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BREAST: METASTATIC: TNBC: 1st Line: IPATUNITY-170

A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

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Malignancy

Breast, TNBC, Triple negative breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Ipatasertib, atezolizumab, paclitaxel

Drug Class

PI3-kinase inhibitor, PD-L1 inhibitor, taxane

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-La Roche

Path

ER negative, PR negative, HER2 negative adenocarcinoma

Key Eligibility Criteria Details
  • Triple-negative adenocarcinoma of the breast either unresectable with curative intent and either locally advanced or metastatic 
    • Most recent biopsy shows ER and PR levels <1%, HER2 <3+
  • No prior systemic therapy for metastatic disease
    • No chemotherapy for early disease in last 12 months
  • Appropriate candidate for paclitaxel monotherapy if PD-L1 negative (or unknown)
  • Appropriate candidate for paclitaxel and atezolizumab if PD-L1 status is positive
  • Appropriate lab values
    • CBC: ANC >/= 1500, Hgb >/= 9, plts >/= 100
    • Chem: CrCl >/=50, Alb >/=3, Gluc </=150 and HgbA1c </= 7.5%, ALT/AST </= 2.5x ULN
    • PT/PTT </= 1.5x ULN
  • No known HIV/HBV/HCV
  • No LVEF <50%
  • No requirement for steroids >10mg prednisone or equivalent
  • No known CNS disease or spinal cord mets
  • No other malignancies in last 5 years except in-situ cervical, non-melanoma skin, or stage I endometrial
  • No history of diabetes
  • No Grade 2 or higher neuropathy
  • No active or history of autoimmune disease
BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: ESR1 mutant: SMX 18001

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation

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Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line or later endocrine tx

Investigational Agent

Lasofoxifene

Drug Class

SERM

PI

Lee Schwartzberg, MD

Sponsor

Sermonix Pharmaceuticals LLC

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • Postmenopausal women with locally advanced or metastatic breast cancer
  • Progression on an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor
  • Demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in metastatic setting)
  • Measurable or non-measurable disease allowed
  • One of the following ESR point mutations in cell-free DNA:
    • Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N
  • May have received up to one chemothearpy regimen in adjuvant or neoadjuvant setting
  • ECOG PS 0-1
  • No prior use of any SERM with following exception
    • OK if tamoxifen previously used in adjuvant setting with relapse at least 1 year after stopping tamoxifen
  • No prior everolimus or PI3K inhibitors
  • No presence of CNS disease
  • No immediate need for chemotherapy
  • No HIV, HBV, HCV
  • No prior malignancy in last 5 years except non-melanoma skin cancer or early stage cervical cancer
  • No uncontrolled HTN
  •  
MELANOMA: ADJUVANT: STAGE 2: KEYNOTE-716

Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

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Malignancy

Melanoma

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp.

Path

Cutaneous

Key Eligibility Criteria Details
  • Stage IIB or IIC Melanoma  (T3b, T4a, T4b). Must be node-negative
  • No prior treatment for melanoma beyond complete surgical resection of current primary lesion
  • Must have received sentinel lymph node biopsy which was negative
  • 12 weeks or less from surgical resection and first study treatment
  • No evidence of metastatic disease on imaging
  • ECOG PS 0-1
  • No known additional malignancy within the past 5 years
  • Must have recovered adequately from surgery
  • No active autoimmune disease requiring systemic treatment in the past 2 years
  • No history of non-infectious pneumonitis
  • No known HIV/HBV/HCV
  •  
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.
MELANOMA: OCULAR MELANOMA: Metastatic: Hepatic dominant: Any line: \\\"FOCUS\\\"

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

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Malignancy

Melanoma, Ocular melanoma, hepatic metastases, skin

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Metastatic Any Line

Investigational Agent

Percutaneous hepatic perfusion of melphalan

Drug Class

Percutaneous hepatic perfusion

PI

Evan Glazer, MD

Sponsor

Delcath Systems Inc.

Path

Ocular melanoma

Key Eligibility Criteria Details
  • Histologically or cytologically proven ocular melanoma to the liver
  • No more than 50% liver parenchema involvement
  • Evidence of limited extrahepatic disease allowed as long as life threatening component of disease is in liver
  • ECOG PS 0-1
  • No Child Class B or C cirrhosis
  • No active HBV or HCV
  • No active CNS mets
PROSTATE: POST-PROSTATECTOMY: PSA RECURRENCE: NRG GU 006

A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer

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Malignancy

Prostate Cancer

Stage

Stage 3

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

1st Line post recurrence

Investigational Agent

Radiation +/- apalutamide

Drug Class

Androgen receptor inhibitor

PI

Dan Vaena, MD

Sponsor

NRG Oncology

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Prostate adenocarcinoma
  • Post-prostatectomy (within last 10 years)
  • Detectable serum PSA (between 0.1 and 1.0 ng/mL) at study entry
  • Any of following
    • Gleason score 7-10
    • >= T3a disease
    • PSA never became undetectable following prostatectomy
  • No nodal involvement
  • KPS 70-100
  • Availability of tissue
  • Prior ADT allowed if previously given for <90 days
  • GFR >35
  • No prior invasive malignancy except in-situ disease, stage I resected melanoma, or disease free for at least 2 years
  • No prior chemotherapy for prostate cancer
  • No prior radiation that would result in overlap
  • No history or predisposition to seizures
  • No IBD
  • No severe CAD
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.
MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
    • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
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: Melanoma, 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, melanoma, SCCHN, RCC, or GC/GEJ cancer
    • 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
  • May have had prior therapy with anti-CTLA-4 or anti-PD-1/L1 therapy
  • Prior treatments limited to no more than 3
  • 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 TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

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Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details
  • Advanced solid tumor or relapsed/refractory lymphoma OR
    • eligible to receive single agent pembrolizumab as standard-of-care OR
    • eligible to receive single-agent docetaxel as standard of care OR
      ​advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
  • Measurable disease
  • ECOG PS 0-1
  • No history of severe autoimmune disease
  • Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy
ADVANCED SOLID TUMORS: Phase 1: Immunotherapy Combination: \"NIVO-GITR\"

A Phase 1/2a dose escalation and cohort expansion study for safety, tolerability, and efficacy of BMS-986156 administered alone and in combination with nivolumab in advanced solid tumors

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Malignancy

Non-small cell lung cancer (NSCLC), cervical cancer, bladder cancer (urothelial cancer, transitional cell carcinoma), head and neck (SCCHN, larynx, oropharynx, hypopharynx, oral cavity), ovarian cancer, hepatocellular carcinoma (HCC)

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line or later

Investigational Agent

BMS-986156 and nivolumab

Drug Class

GITR agonist, anti-PD-1 antibody

PI

Greg Vidal, MD

Sponsor

Bristol-Myers Squibb

Path

Histologic or cytologic confirmation of advanced malignancy. Tissue is required.

Key Eligibility Criteria Details
  • Measurable disease

  • NSCLC

    • If EGFR mut or ALK positive must have received targeted therapy

    • Must have progressed on both platinum doublet and PD-1 therapy

  • Cervical Cancer

    • Persistent, recurrent, or metastatic disease

    • Squamous, adenosquamous or adenocarcinoma histology

    • At least one prior platinum based regimen

    • Confirmation of HPV status

  • Bladder cancer

    • Transitional cell carcinoma involving bladder, urethra, ureter, or renal pelvis

    • Minor histologic variants are acceptable

    • Must have progression or recurrence with platinum-containing regimen (in metastatic setting or within 12 months of peri-operative setting)

  • SCCHN

    • Must have documented HPV status and subtype

    • Prior treatment with platinum containing regimen with progression or recurrence within 6 months of last dose

    • Cannot be amenable to local therapy with curative intent

  • Ovarian

    • Can include epithelial ovarian, primary [peritoneal, or fallopian tube cancer

    • Must have received at least 1 standard systemic therapy for metastatic disease

  • HCC

    • Progressive disease to at least one line of therapy or refuse treatment with sorafenib

    • Child-Pugh score of 6 or less. No encephalopathy and Tbili must be <1.5x ULN

    • HBV and HCV must be tested. HBV viral load <100 IU/mL and must be on anti-viral therapy

    • No clinical ascites or variceal bleeding

  • No more than 5 prior lines of treatment

  • Acceptable lab parameters

  • No active CNS metastatases (treated brain mets may be allowed)

  • No prior malignancy within 2 years (except for in-situ or non-melanoma skin)

  • No autoimmune disease, interstitial lung disease, or requiring immunosuppressive meds

MELANOMA: Metastatic; 1st line; T-VEC+PD-1; \"MASTERKEY-265\"

A Phase 1b/3, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresected,Stage IIIB to IVM1c Melanoma (MASTERKEY-265)_

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Malignancy

Melanoma, skin cancer

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st line

Investigational Agent

Talimogene laherparepvec, pembrolizumab

Drug Class

oncolytic virus, PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Amgen

Path

Melanoma, any BRAF status

Key Eligibility Criteria Details
  • Unresected Stage IIIB, IIIC, or IV melanoma
  • No prior therapy for metastatic disease
  • At least 6 months from adjuvant therapy
  • No clinically active CNS disease
  • ECOG PS 0-1
  • Measurable (at least 1 lesion >1cm)
  • Injectable (total cutaneous/subcut/nodal lesions >1cm in aggregate)
  • No prior ipilimumab, PD-1 inhibitors, T-VEC or tumor vaccines
  • Previous BRAF or MEK inhibitors allowed if BRAF mutated
  • No primary uveal or mucosal melanoma
  • No prior intrathoracic XRT
MELANOMA: Neoadjuvant; Injectable disease; "20110266"

   A phase 2, multicenter, randomized, open-label trial assessing the efficacy and safety of talimogene laherparepvec neoadjuvant treatment plus surgery versus surgery alone for resectable, stage IIB to IVM1a melanoma

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Malignancy

Melanoma, Cutaneous Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

Talimogene laherparepvec (T-VEC)

Drug Class

Oncolytic virus

PI

Martin Fleming, MD

Sponsor

Amgen

Path

Cutaneous melanoma

Key Eligibility Criteria Details

-Histologically confirmed diagnosis of stage IIB, IIIC, or IVM1a melanoma elgible for complete surgical resection

- Measurable disease

- Injectable disease (cutaneous, subcutanous, or nodal lesions) measuring in aggregate > 10mm in diameter

- ECOG PS 0-1

- No ocular or mucosal melanoma

- No history of autoimmune disease

- No known HBV/HCV/HIV

ADVANCED TUMORS: Metastatic; PD-1 monotherapy; “Checkmate 627”

An open label phase 2 multi-cohort trial of nivolumab in advanced or metastatic malignancies

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Malignancy

Histiocytosis, Lynch Syndrome Cancer (non-CRC), Medullary Thyroid, Merkel Cell, Abdominal Mesothelioma, Nasopharyngeal, Small cell (non-lung), Penile, Testicular, Thyroid (papillary or follicular), Thyroid (anaplastic-1st line), Uterine Sarcoma, Vulvar Cancer, Small bowel, Adrenocortical, Appendix, endocervical, adenoid-cystic like (HPV+), Cutaneous Adenocarcinoma, Schwannoma

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or later (unless no primary therapy standard)

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Bristol-Myers Squibb

Path

tumor type specific

Key Eligibility Criteria Details
  • Measurable disease required
  • ECOG PS <1
  • Brain mets allowed but must not be active, cannot require steroids, have at least one measurable lesion outside of brain
  • Excluded tumors:
    • No Pancreatic
    • No endometrial with ER>10%
    • No ovarian
    • No breast
    • No esophageal
    • No gastric
    • No glioma
    • No hepatocellular carcinoma
    • No lymphoma (except primary CNS lymphoma)
    • No leukemia
    • No melanoma
    • No MDS
    • No lung cancer
    • No renal cell
    • No bladder
  • Must not have had other cancer within 2 years
  • No prior PD-1/L-1 or CTLA-4 therapy
  • No autoimmune disease
  • No active steroids
  • No known HIV, HBV, or HCV
  • See "malignancy" list for accepted tumor types
BREAST: METASTATIC: Triple Negative: 1st line or >2nd Line: “CX-839-007”

A multicenter phase 2 study of the glutaminase inhibitor CB-839 in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC) including patients of African ancestry and non-African ancestry

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Malignancy

Breast, Metastatic Breast Cancer, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Cohorts 2 and 4- 1st line; Cohorts 1 and 3- 3rd line or higher

Investigational Agent

CB-839

Drug Class

Glutaminase Inhibitor

PI

Greg Vidal, MD

Sponsor

Calithera Biosciences, Inc.

Path

Triple negative

Key Eligibility Criteria Details
  • Females >18 years old

  • TNBC defined as ER/PR <1%, HER2 negative

  • ECOG PS 0-1

  • Labs within standard limits

  • No known CNS disease unless adequately treated with XRT or surgery and stable by symptoms for at least 2 months prior

  • No other malignancy within 3 years (except non-melanoma skin cancer or in situ cancers)

  • No unstable cardiac disease

  • No known sensitivity Cremaphor

  • Cohort 1- 3rd+ line in African ancestry

    • Must have received prior taxane for metastatic disease but not in most recent treatment

    • Adjuvant therapy counts as therapy if time to recurrence <12 months

  • Cohort 2- 1st line in African ancestry- no prior systemic tx for advanced disease

    • Adjuvant therapy only allowd if time to recurrence >12 mo

  • Cohort 3- 3rd+ line in non-African ancestry

    • Similar to Cohort 1

  • Cohort 4- 1st line in non-African ancestry

    • Similar to cohort 2

COLORECTAL: METASTATIC: RAS/RAF wt: 3rd line: DS8201-A-J203

A phase 2, multicenter, open-label study of DS-8201A in subjects wtih HER2- expressing advanced colorectal cancer

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Malignancy

Colon cancer, rectal cancer, colorectal cancer, CRC

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

3rd Line or greater

Investigational Agent

Trastuzumab deruxtecan (DS8201)

Drug Class

HER2 targeted antibody

PI

Axel Grothey, MD

Sponsor

Daiichi Sankyo, Inc.

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Metastatic or unresectable colorectal cancer.
  • KRAS, NRAS, and BRAF wt
  • Must have at least 1+ on HER2 testing by central vendor
  • Able to provide archival tumor sample
  • ECOG PS 0-1
  • LVEF > or = 50%
  • No surgery or radiation within 4 weeks prior to enrollment
  • No MI within 6 months
  • No symptomatic CHF or elevated troponins within 4 weeks
  • No corneal disease
  • No active CNS mets
  • No other malignancy within 3 years (except solid tumors curatively treated, in situ dz, or non-melanoma skin cancer)
  • No known HIV/HBV/HC
CHOLANGIOCARCINOMA: Metastatic: Liver dominant disease: Hepatic Perfusion: PHP-ICC-203

Randomized, controlled study to compare the efficacy, safety and pharmacokinetics of melphalan/HDS treatment given sequentially following cisplatin/gemcitabine versus cisplatin/gemcitabine in patients with intrahepatic cholangiocarcinoma

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Malignancy

Cholangiocarcinoma, bile duct cancer, intrahepatic cholangiocarcinoma

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Any line

Investigational Agent

Melphalan/HDS by percutaneous hepatic perfusion

Drug Class

chemotherapy perfusion

PI

Evan Glazer, MD

Sponsor

Delcath Systems, Inc.

Path

Cholangiocarcinoma

Key Eligibility Criteria Details
  • Intrahepatic cholangiocarcinoma diagnosed by histology
  • Unresectable disease
  • Less than 50% of liver involved
  • No clinically significant extra-hepatic disease (regional nodes 2cm or less are acceptable)
  • ECOG PS 0-1
  • No history of liver transplantation
  • Hepatic vasculature must be compatible with perfusion (prior Whipple is allowed only if anatomy is compatible)
  • No prior radiation therapy to the liver (including Y-90, I-131, etc.)
  • No prior treatment with percutanous trans-arterial treatment to liver (such as TAE or TACE)
  • No Class II or higher CHF
  • No prior malignancy within 5 years except in-situ disease or non-melanoma skin cancer
  • No active HBV or HCV
  • No CNS disease
  • Plts >100, Hgb >10 (independent of transfusions), ANC >1500
  • Bili <1.5x normal, ALT/AST <5x normal 
ADVANCED SOLID TUMORS: Phase 1; "I3Y-MC-JPBE"
Effects of CYP3A inhibition by clarithromycin on the pharmacokinetics of LY2835219 and its metabolites in cancer patients VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- Advanced Solid Tumors, Breast, Colon, Lung, Prostate, Sarcoma, Bladder, Kidney, Renal, Melanoma, Esophagus, Stomach, Head and Neck, Liver, Pancreatic

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

LY2835219

Drug Class

CDK 4/6 Inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Eli Lilly and Company

Path

Any solid tumor

Key Eligibility Criteria Details
Metastatic solid tumors
ECOG PS 0-2
No symptomatic CNS disease
MOLECULARLY TARGETED: ALK alteration: METASTATIC: >/= 2nd Line: \"MY PATHWAY- ALK\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, breast, CNS (GBM), Liver (HCC), Head and neck (SCCHN), colon, rectum (CRC) bladder, kidney (RCC), prostate, breast, gastric, pancreatic, melanoma (skin)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or greater

Investigational Agent

Alectinib

Drug Class

ALK inhibitor

PI

Ari VanderWalde

Sponsor

Genentech, Inc.

Path

ALK gene rearrangements (by NGS or FISH), ALK mutations (NGS), ALK copy number gain (NGS)

Key Eligibility Criteria Details
  • Metastatic solid tumor
  • ALK alterations as follows
    • ALK gene rearrangements by NGS or FISH using Vysis ALK Break Apart FISH Probe Kit
    • Activating non-synonymous mutations in and around the ALK kinase domain by NGS
    • ALK copy number gains by NGS
    • Patients with melanoma and high ALK expression by IHC
  • ECOG PS 0-2
  • No prior treatment with any ALK inhibitor
  • Following tumor types are not eligible
    • Non-small cell lung cancer (NSCLC)
    • Neuroblastoma
    • Childhood tumors
MOLECULARLY TARGETED: BRAF mut: Metastatic; >/= 2nd line; \"My Pathway- BRAF\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Genital tract (bladder, kidney, ureter), ovarian (ovary), biliary tract (bile duct), endometrial (uterus), prostate

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

> or equal to 2nd line

Investigational Agent

Vemurafenib and Cobimetinib

Drug Class

BRAF inhibitor + MEK inhibitor

PI

VanderWalde

Sponsor

Genentech, Inc.

Path

BRAF activating mutation

Key Eligibility Criteria Details


Metastatic solid tumor_
No known RAS mutation
No melanoma, papillary thyroid, colorectal, or hematologic malignancies2nd line or greater
ECOG PS 0-2
No prior treatment with any BRAF inhibitor (sorafenib is allowed)
No prior treatment with a MEK inhibitor
No active or untreated CNS metastastasis

ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; "113773"
A study to evaluate the effect of repeat oral dosing of GSK2118436 on cardiac repolarization in subjects with V600 BRAF mutation-positive tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- melanoma, colorectal cancer, colon cancer, rectal cancer, lung, brain, pancreas, gastric, stomach, head and neck, prostate, bladder, sarcoma, brain

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

PI

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Path

BRAF mutation

Key Eligibility Criteria Details
Confirmed diagnosis of V600 BRAF-mutation positive tumor
ECOG PS 0-1
No significant ECG abnormalities
No recent CHF, MI, unstable angina, or symptomatic peripheral vascular disease
LVEF >50%
No anti-cancer therapy within 28 days
No known HIV, HBV, HCV
No symptomatic brain mets or >1cm
ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; roll-over; "114144"
A rollover study to provide continued treatment with GSK2118436 to subjects with BRAF mutation-positive tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- melanoma, gastric, colorectal, breast, lung, prostate, pancreas, biliary, head and neck, kidney, bladder, sarcoma, brain

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any, following prior participation on GSK BRF study

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

PI

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Path

BRAF mutation

Key Eligibility Criteria Details
Currently participating in a trial of dabrafenib
No evidence of progressive disease on dabrafenib
No permanentdiscontinuation of dabrafenib for toxicity
No unresolved toxicity of grade 2 or higher
LVEF >50% at transition to this study
QTc <480 ms
No CHF
MELANOMA: Adjuvant: BRAF mutant: "BRIM-8"
A phase III, randomized, double-blind, placebo-controlled study of vemurafenib (RO5185426) adjuvant therapy in patients with surgically resected, cutaneous BRAF mutant melanoma at high risk for recurrence VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Skin Cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

Vemurafenib

Drug Class

BRAF inhibitor

PI

Brad Somer, MD

Sponsor

Hoffman-La Roche

Path

BRAF mutation

Key Eligibility Criteria Details
BRAF mutation (may be enrolled with unknown status as central testing required)
Stage IIC-III

Complete surgical excision within 90 days of start
ECOG PS 0-1
Life expectancy of at least 5 years
No history of limb-perfusion therapy
No history of XRT for melanoma
No prior melanoma systemic therapy
BREAST: Metastatic: Triple-Negative: >2nd Line: ASCENT

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Triple negative, TNBC

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

3rd Line or later

Investigational Agent

Sacitzumab govitecan

Drug Class

Antibody-drug conjugate (ADC) of TROP-2 antibody

PI

Lee Schwartzberg

Sponsor

Immunomedics, Inc

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.
  • Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC. Prior use of cisplatin (or carboplatin) is permitted.
  • Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.
  • Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
  • ECOG performance score of 0 or 1 .
  • Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
  • Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.
  • No Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
  • No Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  • No patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
ADVANCED TUMORS: Metastatic: Immunotherapy combination: ≥2nd line: “Keynote-037”

A Phase 1/2 study exploring the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with epacadostat (INCB024360) in subjects with selected cancers

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

MSI-high colorectal (CRC, colon, rectum); Hepatocellular carcinoma (HCC, liver); Gastric (Stomach)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

≥2nd line

Investigational Agent

Epacadostat and Pembrolizumab

Drug Class

IDO inhibitor and PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Incyte Corporation

Path

if CRC, MSI high. If HCC, no gastric varices by EGD.

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • Fresh baseline tumor biopsies are required unless med monitor approval
  • No active ILD or pneumonitis
  • No active receipt of steroids within 7 days or known immunodeficiency
  • No prior anti-PD-1 or CTLA-4 treatment
  • No known or active CNS mets
  • No history of autoimmune disease
  • For MSI-high CRC
    • MMR or MSI status is, respectively, determined by examining either CRC tumor: protein expression by IHC of 4 MMR enzymes (MLH1/MSH2/MSH6/PMS2) or 3 to 5 tumor microsatellite loci using PCR-based assay. Tumors are classified as MSI high when at least 2 allelic shifts among the 3 to 5 analyzed microsatellite markers are detected by PCR or absence of at least 1 of 4 MMR protein expression is detected by IHC
  • For Gastric cancer (COHORT CLOSED)
    • Must have documentation of HER2 status. IF HER2+ must have progressed or been intolerant of HER2 directed therapy
    • No more than 2 prior lines of therapy
  • For Hepatocellular carcinoma
    • Must be Child-Pugh Class A
    • Must be Barcelona Clinic Liver Cancer Stage C disease (or Stage B disease and either refractory to or not amenable to locoregional therapy
    • No more than 2 lines of prior therapy
    • Must have progressed on or intolerant to sorafenib
    • No history of liver transplant, clear invasion of bile duct or main portal branch, hepatorenal syndrome, or required esophageal variceal ablation within 28 days of study start
    • HBV/HCV only allowed if meet certain criteria
  • For melanoma- (COHORT CLOSED)
    • Known BRAF status
    • No ocular melanoma
  • For bladder/transitional cell (COHORT CLOSED)
    • TCC of bladder, ureter, or renal pelvis
    • 2nd line after progression on platinum (if no platinum received must have documented why unable to tolerate)
  • For RCC (COHORT CLOSED)
    • Clear cell histology
    • Following progression on therapies with established clinical benefit
  • For NSCLC (COHORT CLOSED)
    • 2nd line or later after platinum based therapy for metastatic disease
    • If EGFR or ALK positive, must have received targeted therapy
    • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
  • For SCCHN (COHORT CLOSED)
    • No nasopharyngeal, salivary gland, or non-squamous histology
    • 2nd line or later after failure of platinum-based therapy
    • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
  • For DLBCL
    • No prior allo transplants
    • 2nd line or later
    • Not a candidate for curative tx or SCT
  •  
SKIN CANCER: Squamous cell: Adjuvant: KEYNOTE-630

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Skin cancer; squamous cell skin cancer, non-melanoma skin cancer; SCC, cSCC

Stage

Stage 3

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Squamous cell skin cancer

Key Eligibility Criteria Details
  • Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
  • Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
  • Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins
  • Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
  • Has completed at least 50 Gray (Gy) 25 fractions of adjuvant RT for LA cSCC prior to study entry
  • Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
  • Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
  • ECOG PS 0-1
  • No other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation, Merkel cell carcinoma; or melanoma
  • No prior immunotherapy
  • Must have recovered from all radiation-related toxicities; must have not required corticosteroids; and has not had radiation pneumonitis
  • No active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • No known HIV/HBV/HCV
BREAST: NEOADJUVANT: TRIPLE NEGATIVE: \\\\\\\"KEYNOTE 522\\\\\\\"

A phase III, randomized, double-blind study to evaluate pembrolizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy for triple negative breast cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Neoadjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Merck Sharp & Dohme Corp.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • Previously untreated locally advanced non-metastatic TNBC definedn as one of the following TNM classifications:
    • T1c, N1-N2
    • T2, N0-N2
    • T3, N0-N2
    • T4a-d, N0-N2
  • ECOG Performance Status 0-1
  • No history of other malignancy within 5 years except cervical CIS, or non-melanoma skin cancer
  • No prior therapy with anti-PD-1
  • No active autoimmune disease that required systemic treatment in past 2 years
MOLECULARLY TARGETED: Metastatic; >/= 2nd line; FGFR mutation; "SIGNATURE CBGJ398XUS04"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6- BGJ398 for patients with tumors with FGFR genetic abnormalities VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- breast, lung, melanoma, prostate, colorectal, head and neck, gastric, renal, leukemia, lymphoma, sarcoma, ovarian

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

BGJ398

Drug Class

FGFR inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

FGFR genetic alteration

Key Eligibility Criteria Details

Must have FGFR gene alteration as measured in CLIA-certified lab
None of the following malignancies:
Bladder cancer (urothelial)
Cholangiocarcinoma
Endometrial cancer
Glioblastoma multiforme (GBM)
Received at least 1 prior line of therapy
No standard therapy expected to result in durable remission
ECOG PS 0-1
No CNS disease
No acute/chronic pancreatitis
No impared cardiac function
No corneal or retinal disorder
No other cancer within 3 years
_

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; ALK/ROS1+; "SIGNATURE CLDK378AUS23"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module-7; ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1 VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- breast, colon, prostate, colorectal, sarcoma, melanoma, bladder, renal, head and neck, leukemia, lymphoma, gastric, esophageal, ROS1 positive lung

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

Ceritinib

Drug Class

ALK inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

ALK or ROS1 mutation, translocation, rearrangement, or amplification

Key Eligibility Criteria Details

ALK or ROS1 mutation, trnaslocation, rearrangement, or amplification by CLIA-certified laboratory (IHC or FISH allowed)

May not have ALK+ lung cancer (butROS1 positive lung CA allowed)
Relapsed or progressive disease
ECOG PS 0-1
2nd line or higher
No standard therapy withdurable remission expected
No CNS disease

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; CDK4/6 pathway activation: "SIGNATURE CLEE011XUS03"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8- LEE011 for patients with CDK4/6 pathway activated tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Colorectal, Ovarian, Gastric, Kidney, Leukemia, Lymphoma, Head and Neck, Breast Cancer, Esophagus, Liver, Bladder

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

No further standard therapies

Investigational Agent

LEE011

Drug Class

CDK4/6 Inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

CDK4/6, cyclin D1/3, or p16 aberrations

Key Eligibility Criteria Details

Any of the following molecular alterations
CDK4 amplification or mutation
CDK6 amplification or mutation
Cyclin D1 (CCND1) amplification
Cyclin D2 (CCND3) amplifcation
p16 (CDKN2A) mutationNone of the following malignancies:
ER/PR or HER2 positive breast cancer (TNBC only allowed)
Sarcoma (Eligible but cohort on hold)
Lung Cancer (Eligible but cohort on hold)
liposarcoma
prostate cancer
melanoma
teratoma
mantle cell lymphoma_
ECOG PS 0-1
No CNS involvement
At least one prior metastatic therapy
No expectation that further therapy will result in durable remission
MOLECULARLY TARGETED; Metastatic; >/=2nd line; P2P: "SIGNATURE CMEK162AUS11"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 3- MEK162 for patients with RAS/RAF/MEK activated tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; Bladder, Esophagus, AML (acute myeloid leukemia), small intestine, papillary thyroid

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

MEK162

Drug Class

MEK 1/2 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

Any of following:RAS mutation RAF mutation NF1 mutation MEK mutation

Key Eligibility Criteria Details
None of the following malignancies:
NSCLC (non-small cell lung cancer)
CRC (colorectal cancer)
Melanoma
Pancreatic
Biliary
Low-grade serous ovarian
Mutation in any of the following:
RAF, RAS, NF1, MEK
MOLECULARLY TARGETED: Metastatic; >/=2nd line; P2P; "SIGNATURE CTKI258AUS26"
Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 2 - Dovitinib for patients with tumor pathway activations inhibited by dovitinib including tumors with mutations or translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk, and RET VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; non-squamous NSCLC (non-small cell lung), Melanoma, Ovarian, Thyroid, Multiple Myeloma, GIST (gastrointestinal stromal tumor), AML (acute myeloid leukemia)

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

Dovitinib (TKI258)

Drug Class

Angiogenesis inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

Mutations or transolocations in: FGFR PDGFR VEGF cKIT FLT3 CSFR1 Trk RET

Key Eligibility Criteria Details
Mutation or translocation of at least one of following genes:


FGFR 1/2/3, FLT3, cKIT,VEGFR 1/2, RET,
TrkA (NTRK1),PDGFRa/b,CSF-1R_
None of the following tumors:
Breast
RCC (kidney/renal)
Bladder
HCC (hepatocellular)
Endometrial
Squamous NSCLC
Heme malignancies (exceptFLT3 AML and MM)
At least one prior therapy for disease
ECOG 0-1
No brain mets
No anticoagulation
HEAD AND NECK: LOCALLY ADVANCED: CHEMORAD+/-PD-L1: JAVELIN HEAD+NECK

A randomized double-blind phase 3 study of avelumab in combination with standard of care chemoradiotherapy (cisplatin plus definitive radiation therapy) versus standard of care chemoradiotherapy in the front-line treatment of patients with locally advanced squamous cell carcinoma of the head and neck

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Head and Neck Cancer, Oral cavity, oropharynx, larynx, hypopharynx, SCCHN

Stage

Stage 3

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st

Investigational Agent

Avelumab

Drug Class

PD-L1 inhibitor

PI

Moon Fenton

Sponsor

Pfizer

Path

Squamous cell carcinoma

Key Eligibility Criteria Details
  • Histological diagnosis of squamous cell carcinoma of hte oral cavity, oropharynx, hypopharynx, or larynx
  • Eligible for the following stages:
    • For HPV negative disease
      • Stage III, IVA, or IVB
    • For HPV positive disease that is not oropharyngeal
      • Stage III, IVA, or IVB
    • For oropharyngeal HPV positive disease
      • T4 or N2c or N3
  • No prior therapy for advanced stage SCCHN, must be eligible for CRT with curative intent
  • ECOG PS 0-1
  • No prior immunotherapy
  • No other malignancy within 5 years except CIS or non-melanoma skin cancer
  • No active autoimmune disease
  • No severe cardiac issues with preiouvs 6 months
  • No known HBV/HCV/HIV
MELANOMA; Adjuvant; Stage 2B/C or 3; \"MAVIS\"

A multicenter, double-blind, placebo-controlled, adaptive phase 3 trial of POL-103A polyvalent melanoma vaccine in post-resection melanoma patients with a high risk of recurrence

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Early Melanoma

Stage

Stage 2

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

N/A

Investigational Agent

Seviprotimut-L

Drug Class

Polyvalent Melanoma Vaccine

PI

Ari VanderWalde, MD

Sponsor

Polynoma

Path

Cutaneous (not mucosal or ocular)

Key Eligibility Criteria Details

Stage IIB, IIC, or III Melanoma
Last definitive resection within 90 days of first dose
Complete resection of all known disease
ECOG PS 0-1
Either known BRAF status or 10 unstained slides for BRAF testing
No adjuvant therapy except surgery/radiation, except-
May have had interferon if no longer than 7 days
No use of chronic steroids

MELANOMA: Adjuvant: Stage III-IV(resected): Immunotherapy: "SWOG S1404"

A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High Risk Resected Melanoma

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Skin Cancer, Melanoma, Cutaneous Melanoma, Mucosal Melanoma

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

SWOG

Path

Cutaneous or mucosal melanoma

Key Eligibility Criteria Details
  • Completely resected cutaneous or mucosal melanoma (or unknown primary)

  • Stage IIIB, IIIC, or IV (M1a, M1b, or M1c allowed). IIIA allowed only if N2a

  • May be eligible either at initial presentation or following resection of recurrence

  • Must have undergone wide excision of primary lesion (if present)

  • Full lymphadenectomy required for all patients with positive sentinel nodes

  • Must be registered within 98 days of final surgery for melanoma

  • Must have 5 unstained slides available from original or current tumor

  • Must be disease free on scans within 42 days of therapy

  • ECOG PS 0-1

  • No prior systemic therapy for melanoma

  • Prior radiation is allowed

  • No brain mets (or history of brain mets)

  • No autoimmune disease

  • No HBV or HCV

  • HIV allowed if CD4 counts >350, viral load <25,000

MELANOMA: METASTATIC: 2nd Line post PD-1; Immunotherapy: \"SWOG S1616\"

A Phase II Randomized Study of Nivolumab (NSC-732442) With Ipilimumab (NSC-748726) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Skin Cancer, Cutaneous Melanoma, Mucosal Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or later

Investigational Agent

Nivolumab and Ipilimumab

Drug Class

PD-1 inhibitor and CTLA-4 inhibitor

PI

Ari VanderWalde, MD

Sponsor

SWOG

Path

Cutaneous or Mucosal Melanoma

Key Eligibility Criteria Details
  • Stage 4 or unresectable Stage III melanoma
  • Must have had prior treatment with PD-1 or PD-L1 antibody
    • Must have had best response of SD (no PR or CR) on PD-1 or PD-L1 antibody
    • Must have documented disease progression either while on PD-1 or PD-L1 agents or since stopping therapy with these agents with no intervening treatment
  • No prior therapy with ipilimumab or other anti-CTLA-4 agents
  • No systemic therapy between progression on the PD(L)-1 therapy and registration
  • ECOG PS 0-2
  • No active CNS disease
    • Patients with history of CNS disease must have been treated with XRT or surgery and have no evidence of CNS progression, and been off steroids for at least 14 days
  • No history of autoimmune pneumonitis or colitis that required interruption fo therapy or steroid treatment
  • No known HBV or HCV. HIV is allowed if CD4 count is normal.
  • No ocular melanoma

 

 

 

 

 

OVARIAN: METASTATIC: Platinum Resistant: PHASE 1: 2nd to 5th line: “KEYNOTE-162 Ovarian”

Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian cancer, fallopian tube cancer, primary peritoneal cancer

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line to 5th line

Investigational Agent

Niraparib, Pembrolizumab

Drug Class

PARP inhibitor, PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Tesaro, Inc

Path

High-grade serous

Key Eligibility Criteria Details
  • High-grade serous ovarian, fallopian tube, or primary peritoneal cancer who have recurrent disease and have been previously treated with chemotherapy for advanced/metastatic disease and who experience a response lasting at least 6 months to first-line platinum based-therapy but currently considered platinum-resistant
  • Up to 4 lines of prior therapy allowed in Phase 1 portion, Up to 3 lines allowed in Phase 2 portion
  • May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
  • No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
  • No chronic systemic steroid use
  • No active autoimmune disease that has required treatment in last 2 years
  • No history of interstitial lung disease
  • No history of platelet transfusion for chemo-induced thrombocytopenia
  • No prior anti-PD1 or PARP therapy
BREAST: METASTATIC: TNBC: PHASE 1: 2nd to 4th line:: “KEYNOTE-162 TNBC

Phase 1/2 clinical study of niraparib in combination with pembrolizumab in patients with advanced or metastatic triple-negative breast cancer and in patients with recurrent ovarian cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line to 4th line

Investigational Agent

Niraparib, Pembrolizumab

Drug Class

PARP inhibitor, PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Tesaro, Inc

Path

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

Key Eligibility Criteria Details
  • TNBC who have been treated with at least 1 prior regimen for advanced/metastatic disease or who relapsed/progressed while on or within 1 month from completion of adjuvant chemotherapy
  • Up to 3 lines of prior therapy allowed in Phase 1 portion, Up to 2 lines allowed in Phase 2 portion
  • May not have progressed while on platinum treatment or within 1 month from completion of platinum-containing regimen in any line
  • Measurable disease by RECIST 1.1
  • ECOG PS 0-1
  • No active CNS mets (stable for at least 4 weeks and resolution of symptoms are allowed)
  • No additional malignancy within 5 years (except non-melanoma skin, in situ of  cervix)
  • No chronic systemic steroid use
  • No active autoimmune disease that has required treatment in last 2 years
  • No history of interstitial lung disease
  • No history of platelet transfusion for chemo-induced thrombocytopenia
  • No prior anti-PD1 or PARP therapy
MELANOMA: Metastatic: BRAFmt: \"20149189\"

A Phase 1b trial of talimogene laherparepvec in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Skin cancer

Stage

Stage 4

Phase

Phase 2

Status

Temporarily On Hold

Line Of Therapy

Any, provided no prior therapy with T-VEC or combination of dabrafenib/trametinib

Investigational Agent

Talimogene laherparepvec (T-VEC)

Drug Class

Oncolytic virus

PI

Ari VanderWalde

Sponsor

West Cancer Center/Amgen

Path

Superficial spreading, nodular, lentigo maligna, acral lentiginous, desmoplastic, mucosal

Key Eligibility Criteria Details
  • Age >18 years at the time of informed consent
  • Histologically confirmed diagnosis of melanoma
  • Primary or recurrent Stage IIIB to IV M1c disease for whom surgery is not recommended
  • Must have an activating BRAF mutation (limited to V600E or V600K mutations if subject is being treated first line, but can include any well-defined BRAF mutation after failure of prior immunotherapy)
  • Measurable disease per RECIST 1.1
  • Injectable disease defined as either of the following:
    • At least one injectable cutaneous, subcutaneous, or nodal melanoma lesion >10mm in longest diameter
    • Multiple injectable melanoma lesions that in aggregate have a longest diameter of >10mm
  • ECOG Performance Status 0-1
  • Any number of prior treatment regimens, provided that subject has not previously received T-VEC or combination of dabrafenib/trametinib
  • No clinically active CNS mets
  • No active herpes infection or prior complications of herpetic infections
  • No known HIV, HBV, HCV
  • No known severe autoimmune disease
MELANOMA: Metastatic/Unresectable: Non-visceral: "20120324"
A phase II, multicenter, single-arm trial to evaluate the biodistribution and shedding of talimogene laherparepvec in subjects with unresected, stage IIIB to IVM1c melanoma VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Melanoma, Skin Cancer

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Any (1st, 2nd, 3rd, etc.)

Investigational Agent

T-VEC (talimogene laherparepvec)

Drug Class

oncolytic virus

PI

Ari VanderWalde, MD

Sponsor

Amgen

Path

Any

Key Eligibility Criteria Details

Unresectable IIIB, IIIC, or IV�disease._
Cutaneous, subcutaneous, or nodal disease amenable to intralesional therapy
ECOG PS 0-1
No primary ocular or mucosal melanoma
No symptomatic autoimmune disease
At least one injectable lesion below the waist

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