Clinical trials provide patients the opportunity to receive drugs or therapies years before they’re approved by the FDA. At West Cancer Center, our patients have advanced access to the therapies of tomorrow – today

Stage
Phase
Status
Bladder: Metastatic: Phase I: 2nd Line: Immunotherapy Combination: B-701-U22

A multi-center, single-arm, open-label phase 1b study of a novel FGFR2 inhibitor (B-701) combined with pembrolizumab in subjects with locally advanced or metastatic urothelial carcinoma who have progresseed following platinum-based chemotherapy

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Malignancy

Bladder, Urothelial, Metastatic Bladder Cancer, MBC, Transitional Cell Carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

B-701, pembrolizumab

Drug Class

FGFR3 inhibitor, PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Bioclin Therapeutics, Inc.

Path

Transitional Cell Carcinoma

Key Eligibility Criteria Details
  • Have histologically confirmed locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic transitional cell carcinoma of the urothelium, including of the urinary bladder, urethra, ureter, and/or renal pelvis.
  • Have relapsed after or refractory disease to at least one prior line of systemic chemotherapy for locally advanced or metastatic disease (at least one cycle). At least one regimen should have included a platinum agent unless contraindicated. A regimen of neoadjuvant or adjuvant chemotherapy will be counted as first line chemotherapy if the patient progressed within 12 months of the last dose.
  • Have measurable disease according to RECIST v1.1.
  • Available archival tumor tissue that was obtained at the time or after the subject was found to have muscle invasive or metastatic disease, and is of suitable quality and quantity
  • No history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest CT scan
  • No previous checkpoint inhibitor or FGFR inhibitor.
  • No History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months.
BREAST: Primary Treatment; T<1.5cm; Age>65; ER/PR+ HER2-: "Ice3"

Cryoablation of low risk breast cancer less than 1.5 cm: An evaluation of local recurrence (Ice-3 trial)

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Malignancy

Breast cancer, early

Stage

Stage 1

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Ice-Sense3TM

Drug Class

Cryoablative device

PI

Richard Fine, MD, FACS

Sponsor

IceCure Medical

Path

Invasive ductal carcinomaER positivePR positiveHER2 negativeKi-67 <14%

Key Eligibility Criteria Details

 

  • Age >65
  • Tumor size <1.5cm in greatest dimension
  • Unifocal Primary DiseaseInvasive Ductal Carcinoma
  • ER+, PR+ HER2-
  • Ki-67<14%
  • Nottingham Grade 1-2
  • No microinvasion or extensive intraductal component
  • No multi-focal calcifications
  • No prior or concurrent neoadjuvant therapy
  • No en bloc open biopsy or lumpectomy on tissue specimen
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

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Malignancy

Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

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
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; axillary dissection vs XRT; “Alliance-011202”

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

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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

N/A

Drug Class

N/A

PI

Richard Fine, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Node-positive any histology

Key Eligibility Criteria Details
  • Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
  • No inflammatory breast cancer
  • No other malignancy within 5 years
  • Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
  • Must have documented ER/PR/HER2 status before neoadjuvant therapy
  • Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
  • Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
  • HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
  • Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
  • No neoadjuvant endocrine or radiation therapy
  • No history of prior breast cancer
  • ECOG PS 0-1
  • Must complete surgery within 56 days of finish of neoadjuvant therapy
  • At least 1 sentinel lymph node identified intra-operatively with at least micromets
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+: 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: HER2 neg: 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

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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

TNBC or HR+. Must be HER2 neg

Key Eligibility Criteria Details
  • TNBC or HR+/HER2- adenocarcinoma 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: HR Positive: HER2 Negative: 1st or 2nd line: "CONTESSA"

Randomized, Phase 3 Study of tesetaxel plus a reduced dose of capecitabine versus capecitabine alone in patients with HER2 Negative, HR Positive, Locally advanced or metastatic breast cancer previously treated with a taxane

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Malignancy

Breast, Breast Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st or 2nd Line Chemotherapy after receipt of adjuvant/neoadjuvant taxane. Any number of prior endocrine tx allowed.

Investigational Agent

Tesetaxel

Drug Class

Orally administered taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics

Path

Hormone Receptor Positive, ER Positive, PR positive, HER2 Negative, HER2-

Key Eligibility Criteria Details
  • HER2 negative disease
  • HR (ER and/or PgR) psoitive disease
  • Measurable disease
  • ECOG PS 0-2
  • Must have received prior taxane containing regimen in the neoadjuvant or adjuvant setting
  • If indicated, must have received prior anthracycline containing regimen in neoadjuvant, adjuvant, or metastatic setting
  • Unless not indicated (e.g. rapidly progressing disease), must have received prior endocrine therapy. No limit on number of prior endocrine therapies or targeted therapies (CDK4/6, everolimus)
  • Documented disease recurrence or progression
  • Ability to swallow pills
  • No more than 1 prior chemotherapy regimen for advanced disease (not including targeted therapy)
  • No prior use of a taxane in the metastatic setting
  • No known CNS involvement
  • No other cancer within 5 years
  • No known HIV/HBV/HCV
  • No neuropathy > Grade 1
BREAST: Metastatic: Triple-Negative: >2nd Line: ASCENT

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

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Malignancy

Breast Cancer, Triple negative, TNBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

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.
BREAST; METASTATIC: PHASE 1: 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
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 VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to enrollment

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

BREAST: METASTATIC: Stable brain mets; prior taxane, anthracycline, capecitabine: “ATTAIN”
A Phase 3 open-label, randomized, multicenter study of NKTR-102 versus treatment of physician’s choice (TPC) in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine (ATTAIN) VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Metastatic Breast Cancer, stable brain metastases, MBC

Stage

Stage 4

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

NEKTR 102 (etirinotecan pegol)

Drug Class

pegylated pro-drug

PI

Lee Schwartzberg, MD

Sponsor

Nektar Therapeutics

Path

Adenocarcinoma (any ER/PR/HER2 status)

Key Eligibility Criteria Details
  • Any gender

  • Single-agent cytotoxic chemotherapy indicated

  • Can be measurable or non-measurable disease

  • Must have a history of brain metastases that are non-progressing

  • In TNBC, must have at least 1 prior lines of metastatic cytotoxic therapy

  • In non-TNBC, prior therapy as indicated is required

  • Have received prior therapy with anthracycline, taxane, and capecitabine in any setting (neo-adj, adj, or metastatic)

  • Most recent anti-cancer therapy within 6 months of randomization

  • ECOG PS 0-1

  • No prior SCT

  • No prior camptothecin-derived agent

  • No leptomeningeal disease

  • No HBV/HCV/HIV

  • No cirrhosis

  • No other malignancy within 5 years

  • No need for O2 supplementation

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

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Malignancy

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

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

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
ALLO-HCT: Supportive Care: GVHD tx: GRAVITAS-301

GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

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Malignancy

Leukemia, Lymphoma, Sickle-cell disease, aplastic anemia

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

First line GVHD

Investigational Agent

Itacitinib

Drug Class

JAK-1 inhibitor

PI

Yasir Khaled, MD

Sponsor

Incyte Corporation

Path

N/A

Key Eligibility Criteria Details
  • Has undergone 1 allogeneic stem cell transplant from any type of donor and any donor source for hematologic disorder. Recipients of myeloablative and reduced-intesity conditioning regimens are eligible
  • Clinically suspected Grade II to IV aGVHD per MAGIC criteria
  • Evidence of myeloid engraftment
  • Creatinine <2
  • No more than 1 prior aHCT
  • No more than 2 days of steroids for GVHD
  • No presence of GVHD overlap syndrome
  • No active HBV or HCV
  • No known HIV
  • No relapse of underlying malignancy post aHCT
LIVER CANCER: Unresectable: Child\'s A: First-Line: Immunotherapy: HIMALAYA

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

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Malignancy

Liver cancer, Hepatocellular cancer: HCC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tremelimumab, durvalumab

Drug Class

CTLA-4 inhibitor, PD-L1 inhibitor

PI

Brad Somer, MD

Sponsor

AstraZeneca

Path

Hepatocellular carcinoma

Key Eligibility Criteria Details
  • Confirmed pathologic diagnosis of HCC (from tumor tissue)
  • Must not be eligible for locoregional therapy for unresectable HCC. Patients who progressed on local regional therapy are eligible if therapy was >28 days prior
  • Barcelona Clinic Liver Cancer (BCLC) stage B or stage C
  • Child-Pugh Score class A
  • ECOG PS 0-1
  • HBV or HCV may be allowed depending on activity (may not have both together)
  • Measurable disease
  • No prior receipt of durvalumab, tremelimumab, or sorafenib
  • No prior receipt of any PD-1, PD-L1, or CTLA-4 antibody
  • No autoimmune disease within the last 5 years
  • No CNS mets
  • No fibrolamellar or sarcomatoid HCC or mixed cholagiocarcinoma with HCC
  • No recent steroid use (>10 mg prednisone/day)
LUNG CANCER: Brain metastases: XRT Device: "METIS"

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

NovoCure TTFields

Drug Class

Device administering alternating electrical fields

PI

Matt Ballo, M.D.

Sponsor

NovoCure Ltd.

Path

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

Key Eligibility Criteria Details
  • New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
  • KPS >70
  • 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
    • Largest tumor volume < 10cc
    • Longest tumor diameter < 3cm
    • Cumulative volume of all tumors < 15cc
  • At least one measurable lesion per RANO-BM
  • May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
  • Patient must be able to operate NovoTTF-100M device independently or with caregiver
  • No ALK/ROS-1 alterations. No BRAF, EGFR mutations
  • No significant edema with risk of brain herniation
  • No midline shift > 10mm
  • No intractable seizures
  • No infratentorial or leptomeningeal mets
  • No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
  • No implantable electronic medical devices in the brain
  • No other concurrent brain directed therapy
Lung: Small Cell: Phase 1: Second Line: Immunotx: KEYNOTE PN758

A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

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Malignancy

Small cell lung cancer, SCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

Pegzilarginase and pembrolizumab

Drug Class

Augmented enzyme and PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Aeglea Biotherapeutics

Path

small cell lung cancer, extensive stage

Key Eligibility Criteria Details
  • Extensive stage small-cell lung cancer
  • Has progressed within 6 months of receiving platinum based therapy or intolerant of platinum based therapy
  • ECOG PS 0-1
  • No more than 2 platinum-based regimens for SCLC
  • No prior receipt of PD-1/L-1 agents or CTLA-4 inhibitors
  • No active CNS mets
    • If history of CNS mets, must be stable for at least 4 weeks, and off steroids for at least 7 days
  • No active autoimmune disease requiring treatment in previous 2 years
  • Cannot be receiving more than 3 anti-hypertensive agents
  • No known HIV/HBV/HCV
LUNG: Metastatic: Phase 1: 2nd line or later: FRACTION-LUNG

A phase 2, fast real-time assessment of combination therapies in immune-oncology study in subjects with advanced non-small cell lung cancer (FRACTION-LUNG)

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Malignancy

Lung, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or later

Investigational Agent

nivolumab with either ipilimumab, dasatanib, LAG-3 inhibitor, IDO inhibitor, or others

Drug Class

CTLA-4 antibody anti-LAG-3 antibody, IDO inhibitor, multi-kinase inhibitor, PD-1 antibody

PI

Ari VanderWalde, MD

Sponsor

Bristol-Myers Squibb

Path

Any

Key Eligibility Criteria Details
  • Metastatic Non-small cell lung cancer
  • At least 1 prior line of therapy (2nd line or later)
    • Current arms require patients to be PD-1 naive (this will change)
  • Patients with EGFR or ALK alterations must have received targeted therapy
  • Measurable disease
  • Palliative XRT must be completed at least 2 weeks prior to enrollment
  • Biopsies required pre-treatment, on-treatment, and at progression
  • No active CNS mets
  • No prior malignancy unless CRR achieved at least 2 years prior and no active therapy required
  • No systemic therapy within 4 weeks of enrollment
  • No active autoimmune disease (except skin disorders, hypothyroidism, T1DM)
  • No severe toxicity due to prior immune therapy
  • No symptomatic interstitial lung disease
  • No known HIV/HBV/HCV
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

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Malignancy

Melanoma, Skin cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

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: 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

 

 

 

 

 

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
OVARIAN: Metastatic: Plat Sensitive: >2nd Line: "LIGHT"

Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 2 Prior Lines of Chemotherapy

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Malignancy

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line or greater

Investigational Agent

Olaparib

Drug Class

PARP inhibitor

PI

Adam ElNaggar, MD

Sponsor

AstraZeneca

Path

High-grade serous; 3 of 4 cohorts must be BRCAmt or HRD-positive

Key Eligibility Criteria Details
  • Histologically diagnosed relapsed high-grade serous ovarian cancer (including primary peritoneal and/or fallopian tube)
  • Must have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer
  • Must be partially platinum sensitive (progression 6-12 months after last platinum therapy) or platinum sensitive (progression >12 months after last platinum therapy)
  • ECOG PS 0-1
  • Available archived tissue for central testing
  • No prior PARP inhibitor therapy
  • No other malignancy within last 5 years
  • No pneumonitis
  • No symptomatic uncontrolled brain metastases
  • No known active HBV or HCV
  • No immunocompromised subjects
PROSTATE: Metastatic: Pre-chemo; enza failure; \"KEYNOTE-199\"

Phase II Trial of Pembrolizumab (MK-3475) in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)  (KEYNOTE-199)

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Malignancy

Prostate, Metastatic Prostate Cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Chemo naive, failing enzalutamide

Investigational Agent

Pembrolizumab (added to enzalutamide)

Drug Class

PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Merck Sharp & Dohme

Path

Adenocarcinoma, without small cell histology

Key Eligibility Criteria Details
  • Adenocarcinoma of prostate with no small-cell histology
  • RECIST 1.1 Measurable disease on CT or MRI. Bone met only disease is not currently eligible.
  • Metastatic or locally confined inoperable disease that cannot be treated with curative intent
  • Failing or showing signs of failure on current pre-chemotherapy enzalutamide as defined by PCWG3 guidelines. May have failed prior abiraterone treatment before current enzalutamide treatment.
  • Must have had a clinically meaningful response to enzalutamide therapy
  • Has progression within 6 months prior to screening determined as either of the following:
    • PSA progression (3 rising PSA levels with an interval of at least 1 week between each assessment with screening level at 2 ng/mL or higher) OR
    • Radiographic disease progression in soft tissue or bone
  • Testosterone level <50 ng/dL
  • Must have been on stable doses of bone resorptive agents (if on them at all) for at least 4 weeks
  • ECOG PS 0-2
  • Adequate organ function
  • No other malignancy within the previous 3 years
  • No active autoimmune disease that required systemic treatment in past 2 years
  • No known active CNS disease
  • No prior receipt of immunotherapy
  • No live vaccine within 30 days
  • Measurable disease likely required (one cohort allows bone-only disease but may not be available)
RENAL: METASTATIC: 2nd Line or later: CANTATA

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA

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Malignancy

Renal Cell Carcinoma, Kidney Cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd line

Investigational Agent

CB-839

Drug Class

oral glutaminase inhibitor

PI

Dan Vaena, MD

Sponsor

Calithera Biosciences

Path

Clear cell component

Key Eligibility Criteria Details
  • Metastatic renal cell carcinoma with a clear cell component
  • Karnofsky PS 70% or higher
  • 1-2 lines of prior therapy for advanced or metastaic RCC including at least one antiangiogenic therapy or nivolumab+ipilimumab
  • No prior treatment with cabozantinib or other MET inhibitor
  • No active CNS malignancies
  • No known HIV, HBV, HCV
  • No need for Proton -pump inhibitors
MOLECULARLY TARGETED: MSI-h, TML-h: >/=2nd Line: "MY PATHWAY- MSI, TML"

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Drug Class

PI

Sponsor

Path

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 high
    • As determined by FoundationOne
  • 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: 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

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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

Open to Enrollment

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: Metastatic; Solid Tumors: HER2mt or ERBB3mt: \\\"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, Lung, Colorectal, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Rectal, 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.
  • 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
MOLECULARLY TARGETED: HER2 mut/expr: Metastatic; >/= 2nd line; My Pathway-HER2

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

biliary cancer, cholangiocarcinoma, salivary gland, bladder, transitional cell carcinoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> 2nd line

Investigational Agent

trastuzumab/pertuzumab

Drug Class

anti-HER2 monoclonal antibodies

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Path

HER2 overexpression or amplification

Key Eligibility Criteria Details

 

  • One of the following malignancies
    • Biliary cancer
    • Salivary gland cancer
    • Bladder cancer
  • HER2 overexpression or amplification
  • ECOG PS 0-2
  • No prior treatment with any HER-2 directed therapy
  • No active or untreated CNS metastastasis
  • LVEF must be > or = 50%
ADVANCED SOLID TUMORS: Phase 1: PD1+LAG3+CTLA-4: IO-experienced or naive: 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 1: Non small cell lung cancer (NSCLC), Renal Cell Carcinoma (RCC, kidney cancer), Head and Neck Cancer (Oropharynx, larynx, pharynx, hypopharynx, oral cavity; SCCHN, H+N); Gastric (Stomach) or Gastroesophageal junction (GEJ, GE Junction); Melanoma (Skin). Part 2A: Melanoma, Head and Neck. Part 2B: Melanoma, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

No more than 3 prior lines

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: PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • No active CNS disease (controlled brain mets are allowed)
  • Must have one of the five malignancies below
    • Clear-cell RCC
    • Triple-negative Breast Cancer
    • Squamous cell carcinoma of the head and neck
    • Colorectal cancer
    • Non-small cell lung cancer
  • No other malignancies within 2 years
  • No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
  • No severe autoimmune reactions to immunotherapy
  • No need for active steroid therapy
  • No significant cardiac disease
  • No chronic hepatitis
  • No active interstitial lung disease
  • RCC specific eligibility criteria
    • Previously received one or two anti-VEGFR therapies
    • No more than 3 total prior systemic tx in metastatic setting
    • Must have evidence of progression on or after last treatment received and within 6 months of starting study
  • CRC specific eligibilty criteria
    • Must have received and progressed on at least 1 standard therapy for metastatic disease
    • Must have known MSI status
  • NSCLC specific eligibility criteria
    • Must have progressed on or been refractory to platinum doublet
    • Must have known EGFR, ALK, ROS1 status.
      • Those with EGFR or ALK alterations must have previously received TKI therapy
  • SCCHN specific eligibility criteria
    • Not amenable ot local therapy with curative intent
    • Must have progressed on or been intolerant of platinum containing regimen
  • TNBC specific eligibility criteria
    • Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane
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

Open to Enrollment

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