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BLADDER: METASTATIC: RECEIVING IMMUNOTHERAPY: 12-15 months without growth: A031901

Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial

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Malignancy

Bladder Cancer, Urothelial Carcinoma, Transitional Cell, Renal Pelvis, ureter, urethra

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

After 1st or 2nd line

Investigational Agent

Pembrolizumab, Nivolumab, Atezolizumab, Durvalumab, Avelumab, or Discontinuation

Drug Class

N/A

PI

Dan Vaena, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Urothelial carcinoma with predominantly transitional-cell features

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed urothelial carcinoma with predominantly transitional-cell features
  • Locally advanced or metastatic disease before starting ICI therapy
  • Must be receiving current active treatment with SOC FDA approved PD-1/L1 ICI containing therapy
  • Tumor decrease (either in target or non-target lesions) after 12-15 months on ICI.  Does not need to be formal PR/CR. Any decrease confirmed by repeat scan 4 weeks later is OK
  • ECOG PS 0-2
  • Adequately treated CNS disease is eligible
  • No current immunosuppresive drugs
BREAST: EARLY STAGE Breast Conservation Selene Margin status

A prospective, multi-center, randomized, double-arm trial to determine the impact of the SELENE system on positive margin rates in breast conservation surgery

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Malignancy

Breast

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Selene

Drug Class

Optical Coherence Tomography (OCT)

PI

Richard Fine, MD

Sponsor

PERIMETER

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
  • May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Male
  • Metastatic cancer (Stage IV)
  • Lobular carcinoma as primary diagnosis
  • Previous ipsilateral breast surgery for benign or malignant disease (this includes implants and breast augmentation)
  • Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
  • Subjects with bilateral disease (diagnosed cancer in both breasts)
  • Participating in any other investigational margin assessment study which can influence collection of valid data under this study
  • Use of cryo-assisted localization
  • Currently lactating
  • Current pregnancy
  • Subjects undergoing breast conserving surgery whose resected specimen will be evaluated with intraoperative pathology, frozen section, or imprint cytology
BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
  • ER/PR <10%, HER2 negative
  • ECOG PS 0-1
  • ANC >1200, Hgb >10, Plt >100,000
  • Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
  • No T3 or T4 tumors
  • No definitive surgical treatment performed yet
  • No evidence of metastatic disease
  • No prior history of ipsilateral DCIS or breast cancer
  • No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
  • No other malignancies within 2 years prior
  • No active cardiac disease
  • No uncontrolled hypertension
  • No known HIV/HBV/HCV
  • No neuropathy grade >=2
BREAST: EARLY STAGE: HER2 POSITIVE: POST-NEOADJUVANT: RESIDUAL CANCER: ASTEFANIA

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

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Malignancy

Breast cancer, HER2 positive

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Roche/Genentech

Path

HER2 positive early breast cancer

Key Eligibility Criteria Details
  • HER2 positive invasive breast cancer
  • Stage at disease presentation: any cT2-4, any cN1-3, M0
    • Patients with cT1-3N0-1/M0 at presentation must have pathologic evidence of residual cancer in the axilla at time of surgery
    • Patients with T4 or N2-3 disease must have pathologic evidence of residual cancer in either the breast and/or the axilla
  • Completion of at least 6 cycles and 16 weeks of pre-operative systemic chemotherapy including 9 weeks of a taxane and 9 weeks of trastuzumab
  • Cannot have had a best response to neoadjuvant therapy of progressive disease
  • < or = 12 weeks since primary surgery and randomization
  • ECOG PS 0-1
  • LVEF >or = 50%
  • No prior T-DM1 or immune checkpoint inhibitors
  • Documentation of PD-L1 status
BREAST: Metastatic: ER+, HER2neg, 1st line: persevERA

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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Malignancy

Breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line (pre-chemo)

Investigational Agent

GDC-9545

Drug Class

Selective estrogen receptor degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-LaRoche

Path

ER+ (positive), HER2 - (negative)

Key Eligibility Criteria Details
  • Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
  • Locally advanced or metastatic adenocarcinoma of the breast not curable
  • Documented ER-positive and HER2-negative
  • No prior systemic anti-cancer therapy for metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
  • No prior SERD
  • No active CNS disease
BREAST: METASTATIC: HER2 low (IHC 1+, 2+): DESTINY-BREAST08

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

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Malignancy

Breast Cancer, IDC, ILC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st, 2nd, or 3rd depending on bucket

Investigational Agent

trastuzumab deruxtecan (T-DXd). Various arms contain durvalumab, paclitaxel, capivasertib, anastrozole, fulvestrant, and capectabine

Drug Class

HER2 antibody drug conjugate

PI

Greg Vidal, MD, PhD

Sponsor

AstraZeneca

Path

HER2 IHC 1+ or IHC2+ with negative ISH

Key Eligibility Criteria Details
  • Breast cancer with history of HER2-low expression, defined as IHC2+/ISH negative or IHC1+ with a validated assay
  • May be either hormone receptor positive or negative
  • ECOG PS 0-1
  • If hormone receptor positive disease
    • Part 1: Must have had at least 1 prior treatment line of endocrine therapy with or without a targeted therapy (CDK4/6, mTOR, or PI3K) and at least one prior line of chemotherapy, all for metastatic disease
    • Part 2: Only 1 prior treatment line of ET with or without a targeted therapy. No prior chemothearpy for MBC
  • If hormone receptor negative disease
    • Part 1: At least 1 prior line of chemotherapy for MBC
    • Part 2: For Module 2, no prior lines of thearpy for MBC. For Modules 1 and 3, only 1 prior line fo chemotherapy for MBC
  • No significant cardiovascular disease
  • No history of pneumonitis requiring steroids
    • No clinically active CNS metastatses or spinal cord compression
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo

Drug Class

PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

ER- (negative), PR- (negative), HER2- (negative)

Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • 2nd line
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
BREAST: METASTATIC: TNBC: PHASE 1: 2nd/3rd LINE: MK-5890-01-ARM2A

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Must have measurable disease by RECIST 1.1
  • Diagnosis of TNBC
  • Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
  • Prior therapy should have included anthracycline and/or taxane
  • LDH must be <2x ULN at screening
  • May be PD-L1 treatment refractory (number capped)
  • ECOG PS 0-1
  • No 2nd malignancy within 2 years
  • No active CNS involvement
  • No history of interstitial lung disease
  • No active pneumonitis or history of non-infectious pneumonitis that required steroids
  • No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
  • No known HIV, HBV, HCV
  • No need for steroids at dose of greater than 10mg prednisone or equivalent daily
  • No recent history of substance abuse
Colon: Metastatic PDL 1+ second or later lines

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

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Malignancy

Colon, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

second or later

Investigational Agent

favezelimab/pembrolizumab

Drug Class

Anti-Lag3 + PDL1 inhibitor

PI

Bradley Somer, MD

Sponsor

Merck Sharp & Dohme Corp.

Path

PDL1+

Key Eligibility Criteria Details
  • Metastatic, unresectable colorectal adenocarcinoma, PDL1+
  • Has measurable disease per RECIST 1.1 
  • Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
  • Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
  • ECOG 0-1
  • Life Expectancy >= 3 months
  • Ability to swallow oral medications
  • Has adequate organ function.
  • MMR proficient
  • Does not have active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
  • Has not received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
  • Has not previously received regorafenib or TAS-102.
  • Has not received prior radiotherapy within 2 weeks of start of study intervention.
GBM: Tumor Treating Fields: Post-Debulking: TRIDENT

EF-32 (TRIDENT): Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

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Malignancy

Glioblastoma multiforme, brain cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Following debulking surgery

Investigational Agent

Optune Tumor Treating Fields

Drug Class

Electric field generation

PI

Manjari Pandey, MD

Sponsor

NovoCure GmbH

Path

GBM

Key Eligibility Criteria Details
  • Histologic confirmed diagnosis of GBM per WHO classification criteria
  • Age >or= 22
  • Recovered from maximal debulking surgery, if applicable (gross total resection, partial resection, and biopsy-only patients are all acceptable)
  • Planned treatment with RT-TMZ followed by TTFields and maintenance TMZ
  • KPS >or= 70%
  • Must have stable or decreasing steroid use
  • Concomitant RT with TMZ planned to start no later than 8 weeks post surgery
  • Able to undergo MRI with contrast of brain
  • No infratentorial or leptomeningeal disease
  • No plts <100, ANC <1.5, AST/ALT > 3xULN, Tbili >1.5x ULN, creatinine >1.7
  • No institutionalized patients
  • No active implanted medical devices, bullet fragments, or other skull defects
HEAD AND NECK: Oropharynx: HPV+: Early Stage: XRT: HN 005

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

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Malignancy

Head and Neck, Oropharyx, Oropharyngeal cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Reduced dose radiation with chemo or IO

Drug Class

XRT

PI

Noam VanderWalde, MD

Sponsor

NRG Oncology

Path

HPV positive (+)

Key Eligibility Criteria Details
  • Squamous cell carcinoma of the oropharynx
  • Measurable disease either in primary or lymph node
  • P16 posotive locally
  • T1-2N1M0 or T3N0-1M0
  • No more than 10 pack years of smoking history
  • ECOG PS 0-1
  • No T4 or N2
  • No recurrent disease
  • No supraclavicular nodes
  • No prior malignancy unless disease free for at least 3 years
  • No allergy to cisplatin
Head and neck: Metastatic: 2nd line: Buparlasib: BURAN

The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

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Malignancy

Head and Neck cancer, oropharynx, hypopharynx, larynx, oral cavity, hypopharyngeal, oropharyngeal, laryngeal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

Buparlisib

Drug Class

PI3K inhibitor

PI

Gary Tian, MD

Sponsor

Adlai Nortye Biopharma Co.

Path

Head and neck cancer

Key Eligibility Criteria Details
  • Must have one of the following
    • Disease progression after platinum based chemotherapy (with or without PD-1 therapy) for recurrent or metastatic disease
    • Refractory disease defined as progression or recurrence within six months after the last dose of platinum based chemoradiation for locally advanced disease
  • No more than two prior lines of treatment
  • ECOG PS 0-1
  • Able to swallow and retain oral medications
  • No prior taxane
  • No symptomatic CNS disease
  • No known HIV
  • No symptomatic CHF or LVEF <50%
  • No active psychiatric illness
Head And Neck: Phase 1: NKG2A inhibitor: CA047004

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination with Nivolumab or
Cetuximab in Participants with Advanced Solid Tumors

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Malignancy

Head and neck cancer (SCCHN), laryngeal, hypopharyngeal, oropharyngeal, oral cavity, oropharynx, hypopharynx, larynx

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

BMS-986315 with either nivolumab or cetuximab

Drug Class

NKG2A inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

squamous cell carcinoma

Key Eligibility Criteria Details
  • SCCHN
  • Must have received prior PD-1 or PD-L1 inhibitor
  • ECOG PS 0-1
  • No known autoimmune disease
  • No need for steroids or other immunsuppressive medicine
  • No interstitual lung disease or pulmonary fibrosis
DLBCL: MorphoSys AG: Tafasitamab plus lenalidomide

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the
efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus
R-CHOP in previously untreated, high-intermediate and high-risk patients with newlydiagnosed
diffuse large B-cell lymphoma (DLBCL) [frontMIND]

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Malignancy

Lymphoma

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Tafasitamab plus lenalidomide

Drug Class

Anti-CD19 humanized monoclonal antibody

PI

Jason Chandler, MD

Sponsor

MorphoSys AG

Path

Diffuse Large B cell Lymphoma

Key Eligibility Criteria Details

Major Inclusion Criteria:

  • Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:

    1. DLBCL, NOS including GCB type, ABC type
    2. T-cell rich large BCL
    3. Epstein-Barr virus-positive DLBCL, NOS
    4. Anaplastic lymphoma kinase (ALK)-positive large BCL
    5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
    6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study
    7. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
    8. FL grade 3b
  • Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
  • IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age)
  • Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing lymphoma according to the local pathology report) and the start of treatment (C1D1) ≤ 28 days
  • ECOG performance status of 0, 1, or 2
  • Left ventricular ejection fraction equal to or greater than lower limit of institutional normal range, assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
  • Adequate hematologic function
  •  

Major Exclusion Criteria:

  • Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma
  • History of prior non-hematologic malignancy except for the following:

    1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
    2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
    3. Adequately treated carcinoma in situ without current evidence of disease
  • Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
  • Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
  • Known CNS lymphoma involvement
  • Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
LUNG ROCHE GO41854: SKYSCRAPER-3

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB AND TIRAGOLUMAB COMPARED WITH DURVALUMAB IN PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE STAGE III NON-SMALL CELL LUNG CANCER WHO HAVE NOT PROGRESSED AFTER CONCURRENT PLATINUM-BASED CHEMORADIATION (SKYSCRAPER-03)

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Malignancy

Lung

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Atezolizumab + Tiragolumab

Drug Class

PDL -1 Inhibitor + Anti-TIGIT antibody

PI

Jason Porter, MD

Sponsor

Hoffmann-La Roche

Path

Non small cell Lung Cancer

Key Eligibility Criteria Details

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  • Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
  • At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
  • The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
  • No progression during or following concurrent platinum-based CRT
  • A known PD-L1 result
  • Life expectancy >/= 12 weeks
  • Adequate hematologic and end-organ function
  • Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
  • Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
  • Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

Exclusion Criteria:

  • Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  • NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  • Any evidence of Stage IV disease
  • Treatment with sequential CRT for locally advanced NSCLC
  • Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
  • Any Grade >2 unresolved toxicity from previous CRT
  • Grade >= 2 pneumonitis from prior CRT
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
  • Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
  • Treatment with systemic immunosuppressive medication
  • Women who are pregnant, or breastfeeding
LUNG CANCER: Brain metastases: XRT Device: \\\"METIS\\\"

Pivotal, open-label, randomized study of radiosurgery with or without tumor treating fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)

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Malignancy

Lung Cancer; NSCLC, non-small cell lung cancer; brain metastases

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

NovoCure TTFields

Drug Class

Device administering alternating electrical fields

PI

Matt Ballo, M.D.

Sponsor

NovoCure Ltd.

Path

Non-small cell lung cancer. EGFR wt, ALK/ROS normal

Key Eligibility Criteria Details
  • New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
  • KPS >70
  • 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
    • Largest tumor volume < 10cc
    • Longest tumor diameter < 3cm
    • Cumulative volume of all tumors < 15cc
  • At least one measurable lesion per RANO-BM
  • May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
  • Patient must be able to operate NovoTTF-100M device independently or with caregiver
  • No ALK/ROS-1 alterations. No BRAF, EGFR mutations
  • No significant edema with risk of brain herniation
  • No midline shift > 10mm
  • No intractable seizures
  • No infratentorial or leptomeningeal mets
  • No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
  • No implantable electronic medical devices in the brain
  • No other concurrent brain directed therapy
LUNG: NSCLC: 1st Line: KRAS G12C mt: KRYSTAL-7

A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Malignancy

Non small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

MRTX849 (adagrasib), Pembrolizumab

Drug Class

KRAS G12C inhibitor, PD-1 inhibitor

PI

Jason Porter, MD

Sponsor

Mirati Therapeutics Inc.

Path

Non-small cell lung cancer, KRAS G12C mutation

Key Eligibility Criteria Details
  • Histologically confirmed diagnosis of metastatic or unresectable NSCLC (squamous or nonsquamous) not a candidate for definitive therapy
  • KRAS G12C mutation
  • Known PD-L1 status (can enroll regardless of level)
  • 1st line- no prior treatment for metastatic NSCLC
    • OK to have had radiosensitizing chemo >1 year prior
  • ECOG PS 0-1
  • Measurable disease
  • No active CNS mets
  • No XRT to the lungs within 6 months prior to first dose of study treatment
  • No known autimmune disease
MELANOMA: NEOADJUVANT: STAGE III: KEYNOTE U02-C

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab, MK-7684, V937

Drug Class

Anti-PD-1, Anti-TIGIT, Oncolytic virus

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed melanoma
  • Clinically detectable and resectable Stage IIIB, IIIC, or IIID melanoma
  • Has been untreated for the melanoma with the exception that primary lesion may have been resected or irradiated
  • No known CNS mets
  • No ocular or mucosal melanoma
  • No known HIV/HBV/HCV
  • No active autoimmune disease requiring therapy in past 2 years
  • Must not have received prior oncolytic viruses
MELANOMA:Metastatic: 1st Line: KEYNOTE-U02-B

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02B.

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line, PD-1 naive

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease
  • No ocular or mucosal melanoma
  • No known additional malignancy that is progressing or requires active treatment within the past two years
  • No known CNS metastatses
  • No active autoimmune disease requiring systemic treatment in the past two years
  • No known HIV/HBV/HCV
  • Adequate organ function
MELANOMA: Metastatic: PD-1 refractory: KEYNOTE-U02-A

A Phase 1/2 open-lable rolling-arm umbrella platford design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with melanoma (KEYNOTE-U02): Substudy 02A.

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Malignancy

Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line (post PD-1)

Investigational Agent

Multiple

Drug Class

PI

David Portnoy, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Melanoma

Key Eligibility Criteria Details
  • Has unresectable Stage III or Stage IV melanoma not amenable to curative therapy
  • Has progressed on treatment with an anti-PD1/L1 monoclonal antibody administered either as monotherapy or in combination with other therapies
  • Hsa not received more than 3 lines of therapy
  • No known additional malignancy with past 2 years
  • No known CNS metastases
  • No active autoimmune disease requiring systemic treatment in the last 2 years
  • No known HIV/HBV/HCV
MELANOMA: 2nd line: PD-1 + HSV-virus: RPL-001-16

An open-label, multicenter, Phase 1/2 study of RP1 as a single agent and in combination with PD1 blockade in patients with solid tumors

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Malignancy

Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd

Investigational Agent

RP1 + nivolumab

Drug Class

Oncolytic virus

PI

Ari VanderWalde, MD

Sponsor

Replimune Inc.

Path

Melanoma

Key Eligibility Criteria Details
  • Stage IIIB-IV melanoma, following progression on PD-1 containing regimen
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measruable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
OVARIAN: NEOADJUVANT: Intraperitoneal IL12 and chemo: OVATION 2

A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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Malignancy

Ovarian, fallopian tube, primary peritoneal

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

GEN-1

Drug Class

IL-12 plasmid formulated with PEG-PEI-Cholesterol Lipopolymer

PI

Adam ElNaggar, MD

Sponsor

Celsion

Path

high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS

Key Eligibility Criteria Details
  • Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies (laparoscopic or percutaneous)
  • Histologic documentation of the original primary tumor is required
  • FIGO Stage III-IV
  • Following histologic subtypes eligible: high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma NOS.
  • ECOG PS 0-2
  • No need for treatment with immunosuppressive medication
  • No patients receiving treatment for active autoimmune disease
  • No known CNS involvement
  • No prior abdominal radiation or chemotherapy for abdominal or pelvic tumor
OVARIAN: RECURRENT: PLATINUM RESISTANT: MOONSTONE

A phase 2 open-label, single-arm study to evaluate the efficacy and safety of the combination of niraparib and TSR-042 in patients with platinum-resistant ovarian cancer (MOONSTONE)

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Malignancy

Ovarian, Primary Peritoneal Cancer, Fallopian Tube

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd, 3rd, or 4th line

Investigational Agent

Niraparib and TSR-042

Drug Class

PARP inhibitor and PD-1 antibody

PI

Adam ElNaggar, MD

Sponsor

Tesaro, Inc.

Path

High grade serous, endometrioid, or clear cell

Key Eligibility Criteria Details
  • Recurrent high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer
  • Must be considered resistant to the last administered platinum therapy
  • Must be 2nd, 3rd, or 4th line
  • Must have been previously treated with platinu-based regimen, taxane, and bevacizumab
  • Measurable disease
  • ECOG PS 0-1
  • Did not have disease progression within 3 months of starting first-line platinum therapy
  • No known BRCA mutation
  • No prior therapy with PD-1 or PD-L1 agent
  • No known immunodeficiency or on steroids >10mg/day prednisone or equivalent
  • No uncontrolled CNS disease
  • No other cancers within 2 years
  • No known HIV, HBV, HCV
PROSTATE: 1st Line Chemo: Nivo+Taxotere: Checkmate 7DX

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

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Malignancy

Prostate Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue lesions on CT/MRI
  • ECOG PS 0-1
  • Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
  • Documented disease progression per PCWG3 criteria within 6 months prior to screening
  • Only one prior 2nd generation hormonal therapy in the metastatic setting
    • Patients may have received two prior 2nd gen HT (abi + enza or apalutamide or darolutamide) if and only if the first drug had been used in the non-metastatic setting
  • Chemotherapy naive for metastatic CRPC
  • Must have progressed during or after 2nd gen hormonal therapy or have documented intolerance to 2nd gen HT
  • No active brain mets
  • No known or suspected autoimmune disease
  • No condition requiring systemic corticosteroids (>10 mg prednisone or equivalent)
  • No prior treatment with PD-1 or PD-L1 antibodies
  •  
SKIN CANCER: Non-melanoma: PD-1 eligible: PD-1 and oncolytic virus: RP-001-16

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

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Malignancy

Non-melanoma skin cancer, basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

No prior PD-1

Investigational Agent

RP1, nivolumab

Drug Class

oncolytic virus (HSV), PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Replimune, Inc.

Path

Basal cell carcinoma, cutaneous squamous cell carcinoma, Merkel cell carcinoma, basosquamous carcinoma, high-grade dermatofibroma protuberans, angiosarcoma of the skin, non-HIV-related Kaposi sarcoma, sebaceous gland carcinome, eccrine carcinomas

Key Eligibility Criteria Details
  • Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
    • Basal cell carcinoma,
    • Cutaneous squamous cell carcinoma,
    • Merkel cell carcinoma
    • Angiosarcoma of the skin
    • Eccrine carcinoma
    • high grade dermatofibroma protuberans
    • CTCL is NOT allowed
  • Must have exhausted or refused currently available therapy
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measurable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

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Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details
  • Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
    • CDK4/6 inhibitors (abemaciclib), 
    • PI3 kinase blockers (alpelisib),
    • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
    • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
    • anti ALK TKIs (ceritinib, crizotinib)
    • MEK inhibitor (cobimetinib) 
    • Anti HER2 TKIs (lapatinib, tucatinib)
  • ECOG PS 0-2
  • Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
  • No diarrhea before enrolling on the study (or starting TKI)
  • No ongoing IBS or colitis
  • Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
  • No laxative use within 7 days prior to randomization
MOLECULARY TARGETED: ROS1 FUSION (TAPISTRY ARM A)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort A: Entrectinib in patients with ROS1 fusion-positive tumors

 

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Malignancy

Solid Tumors except for NSCLC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Entrectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • ROS1 fusion positive solid malignancies (except for NSCLC)
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: NTRK1/2/3 FUSION (TAPISTRY ARM B)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort B: Entrectinib in patients with NTRK1/2/3 fusion-positive tumors

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Malignancy

any solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Entrectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Any Solid Malignancy with NTRK1/2/3 Fusion Positivity
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: ALK FUSION (TAPISTRY ARM C)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort C: Alectinib in patients with ALK fusion-positive tumors

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Malignancy

any solid tumors except for NSCLC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Alectinib

Drug Class

selective tyrosine kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with any ALK fusion positive solid malignancy except NSCLC
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: PIK3CA Multiple Mutant Tumors (TAPISTRY ARM H)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort H: Inavolisib (GDC-0077) in patients with PIK3CA multiple mutant-positive tumors

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Inavolisib (GDC-0077)

Drug Class

PI3K-p110α (PIK3CA) inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with at metastatic or advanced solid tumors with at least 2 PIK3CA mutations
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: BRAF II Mutant or Fusion/BRAF III Tumors (TAPISTRY ARM I/J)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohorts I/J: Belvarafenib in patients with BRAF class II mutant/fusion-positive tumors (I) BRAF class III mutant positive tumors (J)

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Belvarafenib

Drug Class

Type II pan-RAF kinase inhibitor

PI

Daniel Vaena, MD

Sponsor

Hoffmann-La Roche

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with advanced or solid malignancy with BRAF class II mutation or fusion (ARM I)
  • Patients with advanced or solid malignancy with BRAF class III mutation (ARM J)
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARY TARGETED: RET Fusion Positive Tumors (TAPISTRY ARM K)

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational For You (TAPISTRY) Phase 2 Platform Trial: Cohort K: Pralsetinib in patients with RET fusion-positive tumors

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Malignancy

Solid Tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Pralsetinib

Drug Class

RET tyrosine kinase inhibitor

PI

Sponsor

Path

Key Eligibility Criteria Details

Inclusion Criteria:

  • Patients with advanced or malignant solid cancers with RET-fusion positive tumors.
  • Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), Response Assessment in Neuro-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
  • Performance status as follows: Participantss aged >= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Participantss aged 16 to < 18 years: Karnofsky score >= 50%; Participants aged < 16 years: Lansky score >= 50%
  • For participants aged >= 18 and <18 years: adequate hematologic and end-organ function
  • Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Life expectancy >= 8 weeks
  • Ability to comply with the study protocol, in the investigator's judgment
  • For female participants of childbearing potential: Negative serum pregnancy test <= 14 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of < 1% per year for the period defined in the cohort-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
  • For male participants: Willingness to remain abstinent or use acceptable methods of contraception as defined in the cohort-specific inclusion criteria
  • In addition to the general inclusion criteria above, participants must meet all of the cohort-specific inclusion criteria for the respective cohort
MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

PI

Sponsor

Genentech, Inc.

Path

ROS1 fusion. Any cancer type except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • ROS1 gene fusion positivity
  • No non-small lung cancer (NSCLC)
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

PI

Sponsor

Genentech, Inc.

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Not Non-small cell lung cancer (NO NSCLC)
  • ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: HER2/ERBB2 amplification or mutation: myTACTIC Arms F/G/H/I

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm F: Trastuzumab emtansine plus atezolizumab   Arm G: PH FDC SC  Arm H: PH FDC SC plus chemotherapy Arm I: trastuzumab emtansine plus tucatinib, in patients with ERBB2 gene amplification- or mutation-positive tumors.

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior

Investigational Agent

TDM-1 with atezolizumab, or PH FDC SC with or without chemotherapy, or TDM-1 with tucatinib

Drug Class

Anti-HER2 agents

PI

Sponsor

Genentech, Inc.

Path

ERBB2 amplification or specific mutation

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • ​TMB must be <10 mutations/megabase
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: HER2/ERBB2 amp or mut; TMB-h: myTACTIC Arm J

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

TD-M1 + atezolizumab

Drug Class

anti-HER2 agent and anti-PD-L1 agent

PI

Sponsor

Genentech, Inc.

Path

ERBB amplificaiton or mutation AND TMB-h or MSI-h or dMMR

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • Must ALSO have one of the following alterations
    • ​TMB > or =10 mutations/megabase
    • MSI-h
    • dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
Advanced Solid Tumors: Niraparib and Dostarlimab in HRD Solid Tumors

A Phase II Trial of Niraparib and Dostarlimab Combination Therapy in Patients
with Somatic Homologous Recombination Deficient Advanced or Metastatic
Cancer

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Malignancy

solid tumors

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

any

Investigational Agent

Niraparib and Dostarlimab

Drug Class

PARP inhibitor + IgG4 humanized monoclonal antibody resulting in PDL1/2 inhibition.

PI

Gregory Vidal, MD

Sponsor

West Cancer Center

Path

somatic HRD deficiency

Key Eligibility Criteria Details
  1. Metastatic, recurrent, or unresectable solid tumor with a pathogenic, or presumed pathogenic, somatic mutation of one of the following homologous recombination deficiency (HRD) gene mutations:  BRCA1, BRCA2, ATM, RAD51B, RAD51C, RAD54L, RAD51D, FANC/BRIP1, FANCI, FANCL, FANCN(PALB2), BARD1, CHEK1, CHEK2, CDK12, or PPP2R2A.

  2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  3. Participant must be ≥ 18 years of age
  4. Participant must have adequate organ function, defined as follows:

    • Absolute neutrophil count ≥ 1,500/µL
    • Platelets ≥ 100,000/µL
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min using the Cockcroft-Gault equation
    • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
    • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
    • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  5. Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to use a highly effective method of contraception from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
    • ≥45 years of age and has not had menses for >1 year
    • Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
    • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 5.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

h. Male participant agrees to use a highly effective method of contraception (see Section 5.4 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.

j. If an appropriate archival tumor tissue sample is not available, patient is willing to undergo a pre-treatment tumor biopsy.

Exclusion Criteria:

  1. Patients with the following malignancies will be excluded:

    • Prostate cancer
    • Ovarian, breast, and pancreatic patients with known germline BRCA1 or BRCA2 mutation
    • Platinum sensitive ovarian cancer (defined as recurrence > 6 months from last platinum agent), unless platinum intolerant.
ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

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Malignancy

Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line (post standard therapy)

Investigational Agent

COM-701, BMS-986207, nivolumab

Drug Class

PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen, Ltd

Path

PVRL2 high (only for basket cohort)

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior therapy with immune therapy are eligible (except in ovarian cohort)
  • In Expansion cohorts patients must either have
    • Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
    • Advanced MSS endometrial cancer
    • A different malignancy that has high expression of PVRL2
  • No active autoimmune disease
  • No interstitial lung disease
  • No active CNS metastases
  • In ovaran cohort, no prior immunotherapy
  • No prior therapy with PVRIG inhibitor or anti-TIGIT antibody
ADVANCED SOLID TUMORS: Phase 1: PD1+LAG3+CTLA-4: 1st LINE: CA 224-048

A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

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Malignancy

Part 2A: Head and Neck. Part 2B: NSCLC (lung)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st line

Investigational Agent

Relatlimab with nivolumab and ipilimumab or relatlimab with nivolumab and BMS-986205)

Drug Class

LAG-3 inhibitor with PD-1 inhibitor and either CTLA-4 inhibitor or IDO inhibitor

PI

Ari VanderWalde

Sponsor

Bristol-Myers Squibb

Path

Selected solid tumor types

Key Eligibility Criteria Details

Part 1:

  • Locally advanced or metastatic NSCLC, or SCCHN
    • NSCLC and SCCHN must have received prior platinum-based therapy
    • Patients with targetable mutations (e.g. ALK, ROS, EGFR, etc.) must have had prior treatment with approved targeted therapy
  • 1st line- no prior therapy for metastatic disease
  • ECOG PS 0-1
  • LVEF 50% or higher
  • No known CNS mets
  • No history of pneumonitis
  • No prior cancer within 3 years (except locally curable cancers)
  • No history of life-threatening toxicity to immunotherapy
  • No known HBV/HCV/HIV
ADVANCED SOLID TUMORS: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

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Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
  • Must not be eligible for curative resection
  • Must be positive for at least 1 of the following human leukocyte antigens:
    • HLA-A*02:01
    • HLA-A*02:06
    • HLA-A*24:02
    • HLA-A*03:01
    • HLA-B*15:01
  • ECOG PS 0-1
  • No known CNS mets
  • No known HIV/HBV/HCV
ADVANCED SOLID TUMORS: SCLC, GEJ, PDAC, Endometrial: PEN-866-001

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

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Malignancy

Anal cancer, Pancreatic cancer, PDAC, Cervix, cervical cancer, Gastric cancer, Gastroesophageal cancer, SCLC, Small cell lung cancer, penile, vulvar

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or later

Investigational Agent

PEN-866

Drug Class

HSP-90 inhibitor

PI

Dan Vaena, MD

Sponsor

Tarveda Therapeutics

Path

adenocarcinoma or squamous cell carcinoma

Key Eligibility Criteria Details
  • One of the following malignancies
    • Small cell lung cancer: locally recurrent or metastatic SCLC whose disease has progressed after at least 1 prior line of chemo
    • Gastric or GEJ adenoCA: Disease that has progressed after at least 1 prior line of chemo
    • SCC of genitalia (anus, cervix, vulva, or penis): disease that has progressed after at least 1 prior line (adjuvant counts as prior line)
    • Pancreatic CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
    • Endometrial CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
  • ECOG PS 0-1
  • Measurable disease
  • No prior topoisomerase I inhibitor
  • No symptomatic CNS involvement
  • No known HIV/HBV/HCV
ADVANCED SOLID TUMORS: PHASE 1: NKG2A inhibitor: CA047004

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination with Nivolumab or
Cetuximab in Participants with Advanced Solid Tumors

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Malignancy

Advanced Solid Tumors, renal cell, head and neck cancer (SCCHN), non-small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

BMS-986315 with either nivolumab or cetuximab

Drug Class

NKG2A inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Key Eligibility Criteria Details
  • Renal cell, NSCLC, or SCCHN
  • Must have received prior PD-1 or PD-L1 inhibitor
  • ECOG PS 0-1
  • No known autoimmune disease
  • No need for steroids or other immunsuppressive medicine
  • No interstitual lung disease or pulmonary fibrosis
METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

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Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, metastatic solid malignancy
  • Has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior PD-1/PD-L1 allowed
  • No other malignancy within 2 years prior
  • No active autoimmune disease requiring systemic therapy within last 2 years
  • No chronic steroids or immunosuppressants.
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