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BLADDER: Metastatic: 1st line: Cisplatin Ineligible: HCRN GU15-215

A Randomized Phase II Trial of Atezolizumab With or Without Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer: Hoosier Cancer Research Network GU15-215

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Malignancy

Bladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Atezolizumab and Bevacizumab

Drug Class

PD-L1 Antibody; VEGFR Antibody

PI

Dan Vaena, MD

Sponsor

Hoosier Cancer Research Network

Path

Transitional Cell Carcinoma

Key Eligibility Criteria Details
  • ECOG PS 0-2
  • Histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
  • Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
  • Evaluable untreated tumor tissue for biomarker analysis.
  • Willing to undergo a core needle or excisional biopsy on-treatment.
  • Measurable disease
  • No prior chemotherapy for locally advanced or metastatic urothelial cancer
    • Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted
  • Ineligible for cisplatin as defined by presence of one or more of the following:
    • Impaired renal function [GFR ≥ 30 but ≤ 60 cc/min].
    • Grade ≥ 2 Hearing Loss (hearing loss measured by audiometry of 25 dB at two contiguous frequencies)
    • Grade ≥ 2 peripheral neuropathy
    • ECOG Performance Status of 2
    • Solitary Kidney
  • No Active or untreated central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
    • Evaluable or measurable disease outside the CNS
    • No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
    • No history of intracranial or spinal cord hemorrhage
    • No evidence of significant vasogenic edema
    • No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose allowed
    • No stereotactic radiation, whole-brain radiation within 4 weeks prior to Cycle 1 Day 1
    • Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy within 3 months prior to Cycle 1 Day 1 will be excluded
  • No malignancies other than urothelial cancer within 5 years prior
  • No history of autoimmune disease
  • Known HIV, HBV, or HCV
  • No inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)
BLADDER: METASTATIC: FIRST LINE: IMMUNOCHEMO COMB: NILE

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

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Malignancy

Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma, Ureter, Renal Pelvis

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Durvalumab, Tremelimumab

Drug Class

PD-L1 antibody, CTLA-4 antibody

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Path

Transitional cell carcinoma

Key Eligibility Criteria Details
  • Unresectable or metastatic transitional cell carcinoma or the urothelium (renal pelvis, ureters, urinary bladder, or urethra)
    • Both transitional cell and mixed transitional/non-transitional cell histologies are permitted
  • No prior 1st line therapy for metastatic disease
    • Prior adjuvant therapy allowed if it has been >12 months since last therapy
    • Prior local intervesical chemo or immune therapy is allowed if at least 28 days before study treatment
  • Either cisplatin-eligible or cisplatin-ineligible but carboplatin eligible patients are allowed
  • Measurable disease
  • ECOG PS 0-1
  • No prior immunotherapy with exception of BCG or antitumor vaccines
  • No autoimmune disease requiring immunosuppression
  • No untreated CNS disease
  • No contraindications to platinum-based doublet chemotherapy
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 BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"
A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Path

Node positive prior to surgery, pathologically node negative at surgery

Key Eligibility Criteria Details
  • Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma).  Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).

  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)

  • Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.

  • HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)

  • Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen

  • For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization

  • Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.

  • At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer

  • ECOG PS 0-1

BREAST: ADJUVANT: ER/PR+: CDK4/6: NATALEE

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

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Malignancy

Breast cancer, Invasive breast cancer, BC

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Aduvant

Investigational Agent

Ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER or PR positive (HR+), adenocarcinoma

Key Eligibility Criteria Details
  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Positive for ER and/or PgR
  • HER2 negative
  • Patient has had surgical resection where tumor was removed completely with negative margins
  • Anatomic Stage II or III
  • Completed neoadjuvant or adjuvant chemotherapy (if indicated)
  • Completed adjuvant XRT (if indicated)
  • Plan to treat pt with endocrine tx for 5 years
  • No prior CDK4/6 inhibitor
  • No prior tamoxifen, ralixofene, or AIs for chemoprevention
  • No prior tx with anthracycline at cumulative doses of 450mg/m2 or more
  • No distant metastatic disease
  • No other cancer within 2 years of study enrollment
  • No known HIV/HBV/HCV
  • No clinically significant cardiac disease
BREAST: Adjuvant: ER/PR+: HER2-; \"e3\"

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy

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Malignancy

Breast, early breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Path

Key Eligibility Criteria Details

High risk early breast cancer as defined as follows:

  • Post adjuvant chemo withTumor >2cm, N0, Oncotype Dx >25 or
  • Post adjuvantchemo with 1-3 positive nodes, OncDx >25 or
  • Post adjuvant chemo with >3 positive nodes or
  • Post neoadjuvant chemo with >3 positive nodes

HER2 negative, ER/PR positive
Completed standard neoadjuvant or adjuvant taxane or anthracycline therapy
No prior receipt of MTOR inhibitors
ECOG PS 0-2
Fasting cholesterol <300, TG <2.5x ULN
HIV positive allowed if controlled CD4 count and NOT on ART

BREAST: METASTATIC: TNBC: AKT/PIK3CA/PTEN: 1st Line: \"IPATunity130\"

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (HR+ ARM CLOSED)

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Malignancy

Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line chemo

Investigational Agent

Ipatasertib

Drug Class

PI3 kinase inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

Triple negative breast cancer

Key Eligibility Criteria Details
  • Triple negative cancer of the breast, locally advanced or metastatic not amenable to curative resection
  • ECOG PS 0-1
  • Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status by NGS
    • AKT1 missense mutations at E17, L52, or Q79
    • PIK3CA missense mutations at R88, G106, K111, G118, N345, C420, E453, E542, E545, Q546, M1043, H1047, or G1049
    • PTEN homozygous deletion, dominant negative short variant (C124S, G129E, or R130X), less of heterozygosity with copy number 1, double hit 
  • No known brain mets
  • No prior cancers within 5 years
  • No known HIV
  • No cirrhosis
  • No active steroid use (> or = 10mg prednisone/daily)
  • No clinically significant cardiac dysfunction including EF<50%
  • No insulin dependent diabetes
  • No Grade >=2 uncontrolled or untreated hyperlipidemia/hypertriglyceridemia
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: 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
BREAST: METASTATIC: HER2+: Prior T-DM1: DESTINY-Breast02

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

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Malignancy

Breast Cancer, Invasive breast Cancer, BC, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line or 3rd line (prior T-DM1)

Investigational Agent

Trastuzumab deruxtecan (DS8201a)

Drug Class

HER-2 targeted ADC

PI

Greg Vidal, MD, PhD

Sponsor

Daiichi Sankyo, Inc.

Path

HER2 positive

Key Eligibility Criteria Details
  • Histologically confirmed unresectable or metastatic breast cancer
  • HER-2 positive (HER2+) by ASCO-CAP guidelines and confirmed by central lab
  • Previously treated with T-DM1
  • Progression following last treatment (cannot go on after stopping treatment for toxicity alone)
  • No prior capecitabine
  • No history of insterstitial lung disease or pneumonitis requiring steroids
  • No active CNS disease
BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: EMERALD

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

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Malignancy

Breast, invasive breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line (post CDK4/6 inh)

Investigational Agent

Elacestrant

Drug Class

Selective Estrogen Receptor Degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Radius Pharmaceuticals, Inc.

Path

adenocarcinoma, ER/PR +, HER2-

Key Eligibility Criteria Details
  • Subjects with adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or XRT, or metastatic disease
  • Must be appropriate candidates for endocrine monotherapy
  • Either measurable disease or bone-only (nonmeasurable) disease
  • Post-menopausal women or men
  • Must be ER+, HER2 -
  • Must have received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer
  • Must have received prior treatment with CDK4/6 inhibitor in combination with either fulvestrant or an AI
  • No more than one line of chemotherapy in the advanced/metastic setting
  • No prior treatment with investigational SERD or ER antagonist
  • No presence of symptomatic visceral 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
  •  
BREAST: METASTATIC: ER/PR+: HER2 neg: No prior taxane: CONTESSA 2

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

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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

1st line chemo (most likely)

Investigational Agent

tesetaxel

Drug Class

oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER/PR positive, HER2 negative

Key Eligibility Criteria Details
  • Pathologically confirmed locally advanced unresectable or metastatic breast cancer
  • HER2 negative (-) disease
  • Hormone receptor (ER and/or PR) positive (+)
  • Measurable disease
  • CNS disease is allowed provided that patient is neurologically stable on maximum dose of 4mg dexamethosone, no leptomeningeal disease, and no local-directed CNS treatmnt is immediately necessary
  • ECOG PS 0-2
  • No limit on number of prior endocrine therapies
  • No more than 2 prior lines of chemotherapy
  • No prior treatment with either capecitabine or any taxane
  • No other malignancies within 5 years except with discussion with medical monitor
  • No HIV, HBV, HCV
  • No Grade 2 or higher neuropathy
  •  
BREAST: METASTATIC: HER2 negative: 1st Line: Older Adults: CONTESSA TRIO >65

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast, Metastatic Breast Cancer, MBC,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Tesetaxel

Drug Class

Oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

HER2 negative (Any ER or PR status)

Key Eligibility Criteria Details
  • Age 65 or older
  • Locally advanced breast cancer not considered curable by surgery or radioation or metastatic breast cancer
  • Measurable Disease
  • Brain mets are allowed
  • ECOG PS 0-2
  • If ER/PR+, must have received prior therapy with endocrine therapy (+/- CDK 4/6 therapy).
  • Any number of prior endocrine or targeted therapies are permitted
  • No prior chemotherapy for metastatic disease
  • No known HIV/HBV/HCV
  • No Grade >1 neuropathy
BREAST: METASTATIC: TNBC: 1st Line: CONTESSA TRIO

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tesetaxel, nivolumab, pembrolizumab, atezolizumab

Drug Class

oral taxane, PD-1 or PD-L1 inhibitors

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • ER -, PR-, HER2 - biopsy proven breast cancer
  • Locally advanced (not curable by surgery or radiation) or metastatic
  • No prior chemotherapy for metastatic disease
  • (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
  • No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
  • Tissue available for PD-1 level determination
  • ECOG PS 0-2
  • No known HIV/HBV/HCV
  • No history of active autoimmune disease
  • No Grade 2 or higher neuropathy
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 2nd 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
  • 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
ENDOMETRIAL: METASTATIC: PHASE 1: 2nd/3rd LINE: MK-5890-001-ARM2B/C

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

Uterine, Endometrial

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

Key Eligibility Criteria Details
  • Must have diagnosis of endometrial cancer
  • Must have received or been intolerant to no more than 2 prior lines of treatment
  • Prior treatment should have included platinum containing regimen
  • May be PD1 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
LUNG: NSCLC: STAGE III: POST-CHEMO-XRT: COAST

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

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Malignancy

Lung cancer, non-small cell lung cancer, NSCLC

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Post-chemoXRT

Investigational Agent

durvalumab alone or in combination with oleclumab or monalizumab

Drug Class

PD-L1 inhibitor, CD73 antibody, NKG2A antibody

PI

David Portnoy, MD

Sponsor

AstraZeneca

Path

adenocarcinoma or squamous cell carcinoma, or large cell carcinoma, or brochoalveolar carcinoma

Key Eligibility Criteria Details
  • NSCLC with locally advanced, unresectable, Stage III disease
  • Must have completed, without progression, definitive chemoradiation within 28 days of randomization
  • ECOG PS 0-1
  • Must have at least one previously irradiated tumor lesion that is measurable at time of study entry
  • No pneumonitis Grade 2 or higher from chemoXRT
  • No tuberculosis, HBV, HCV, or HIV
  • No mixed histology (small-cell and non-small cell)
  • No recent severe cardiac disease
    • No history of other primary malignancy
LUNG: NSCLC: METASTATIC: Non-squamous: 1st Line: LEAP-006

A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

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Malignancy

Lung cancer, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VGFR antibody, PD-1 antibody

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed metastatic nonsquamous NSCLC
  • EGFR wt, ALK-wt, ROS1-wt
  • Measurable disease per RECIST 1.1
  • ECOG PS 0-1
  • No prior PD-(L)1 therapy in adjuvant setting
  • First line metastatic:
    • Prior adjuvant therapy with radiation/surgery/chemo allowed if completed >6 months prior to relapse.
  • Adequately controlled BP defined as BP <150/90 with no change in antihypertensive meds within 1 week prior to randomization
  • No known untreated CNS mets
  • No history of pneumonitis that required steroids
  • No major blood vessel invastion or large volume hemoptysis
  • No known HIV/HBV/HCV
  • No active autoimmune disease
  • No prior hypersensitivity to monoclonal antibodies
LUNG: METASTATIC: PHASE 1: ADENOCA: 1ST LINE: MK-5890-001-ARM3

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

Lung cancer, non-squamous lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st Line (or 2nd line in rare cases)

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Key Eligibility Criteria Details
  • Histologically or cytologicall confirmed Stage IV (M1a or M1b) non-squamous NSCLC
    • Mixed histologies allowed if predominant type non-squamous
    • No small cell allowed (even if non-predominant part of mixed histology)
    • May be untreated or could have received 1 prior regimen
    • EGFR or ALK positive should have had prior treatment with TKI
  • No prior radiation therapy to the lung >30Gy within past 6 months
  • Must have measurable disease by RECIST 1.1
  • 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
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

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Malignancy

Melanoma, Skin Cancer, Cutaneous Melanoma, Mucosal Melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

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: 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: 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

Open to Enrollment

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: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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Malignancy

Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

Key Eligibility Criteria Details
  • Metastatic or surgically unresectable solid tumor
  • Measurable disease
  • Documentation of an FGFR1-3 gene mutation or translocation
  • At least 1 prior line of therapy with progression
  • No other therapy available likely to provide clinical benefit
  • ECOG PS 0-2
  • No other FGFR inhibitors within last 6 months
  • No clinically significant corneal or retinal disorder
  • No untreated CNS disease (except primary brain cancer)
  • No additional malignancy at current time requiring active treatment
  • No history of calcium or phosphate disorder or systemic mineral imbalance
  • No clinically significant cardiac disease
  • No active HBV/HCV
  • No known HIV
MOLECULARLY TARGETED: TMB-high: >/=2nd Line: MY PATHWAY- TMB

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

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Malignancy

Breast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2ndline or later

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech

Path

Solid tumor

Key Eligibility Criteria Details
  • PD-L1 copy number gain/amplification (likely available on Foundation only)
  • Patients with MSI-high
    • Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
  • Patients with dMMR
    • Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
  • Patients with total mutational burden (TMB) high
    • 10 mut/Mb per any CLIA certified test
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
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
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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