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: 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: 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.
BLADDER: Metastatic: PHASE 1: PD-1 Naive: 2nd Line: "PROPEL BLADDER"

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

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Malignancy

Bladder, Transitional Cell Carcinoma, TCC, Urothelial Carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd (1st if patient refuses platinum-based therapy)

Investigational Agent

NKTR-214, atezolizumab

Drug Class

pegylated IL-2, PD-L1 inhibitor

PI

Dan Vaena, MD

Sponsor

Nektar Therapeutics

Path

Urothelial Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed locally advanced or metastatic urothelial carcinoma
  • ECOG PS 0-1
  • Measurable disease per RECIST 1.1
  • No prior receipt of immunotherapy with immunomodulators (eg. PD-1 inhibitors, CTLA-4 inhibitors, IDO inhibitors)
  • Either;
    • No more than 1 prior line of platinum-containing therapy with disease progression on or following this therapy OR
    • Patient refuses standard of care therapy in the 1st line
  •  No history of or active autoimmune disease (exceptions include Hashimoto's thyroiditis, Graves' disease, TIDDM, or Med Monitor approval)
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: Neoadjuvant: Phase 1: HER2+: Immunotherapy combination: “GO29831- Neoadjuvant”

A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer

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Malignancy

Breast Cancer, Breast Neoadjuvant, HER2+

Stage

Stage 2

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Atezolizumab

Drug Class

PD-L1 antibody

PI

Greg Vidal, MD

Sponsor

Hoffmann-La Roche

Path

HER2 positive

Key Eligibility Criteria Details
  • Men or women

  • Primary tumor size >2cm

  • Stage at presentation cT2-cT4, cN0-cN3, cM0

  • HER2 positive disease (ISH positive and/or 3+ by IHC)

  • HLA-A2 positive (by central laboratory)

  • ECOG PS 0-2

  • Adequate lab tests

  • Baseline LVEF >50% by ECHO or MUGA

  • No prior systemic therapy for treatment or prevention of breast cancer

  • No history of DCIS unless >5 years prior to current diagnosis

  • No Grade 2 or higher peripheral neuropathy

  • No history of autoimmune disease, need for current immunosuppressants

  • No HBV/HCV/HIV

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 (following chemo): ER positive: HER2 negative: \"EarLEE-1\"

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

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Malignancy

Breast Cancer, Hormone Receptor Positive Breast Cancer

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Following (neo)adjuvant chemo

Investigational Agent

ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER/PR +, HER2-

Key Eligibility Criteria Details
  • Histologically confirmed unilateral primary invasive adenocarcinoma of the breast
  • Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer
  • Patient is after surgical resection of the tumor where tumor was removed completely,
  • Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue
  • Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ≥ 4 cycles or ≥ 12 weeks which included taxanes prior to screening
  • Patient has completed adjuvant radiotherapy (if indicated) prior to screening
  • Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
  • ECOG PS 0-1
  • No prior treatment with CDK4/6 inhibitor
  • No prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
  • No prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin
  • No distant metastases of breast cancer beyond regional lymph nodes
  • Uncontrolled hypertension with systolic blood pressure >160 mmHg
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: 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

COLON/RECTAL: Metastatic: 2nd Line: “CanStem303C”

A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)

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Malignancy

Colon, metastatic CRC, rectal cancer, colorectal, rectum

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd line

Investigational Agent

BBI-608 (napabucasin)

Drug Class

STAT3 inhibitor

PI

Brad Somer, MD

Sponsor

Boston Biomedical, Inc.

Path

colorectal

Key Eligibility Criteria Details
  • Metastatic histologically confirmed CRC
  • Must have failed treatment with one regimen containing a fluoropyrimidine and oxaliplatin for metastatic disease. All patients must have received a minimum of 6 weeks of the first line therapy. Treatment failure is defined as radiologic progression during or <6 months after the last dose of first-line therapy (including adjuvant)
  • ECOG PS 0-1
  • Must give access to either archived or new biopsy
  • No more than 1 prior chemo regimen in metastatic setting
  • No other cancers within 3 years 
HEAD AND NECK: ORAL CAVITY: NEOADJUVANT: "INSPIRE"

A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy with the IRX-2 regimen in Patients with Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

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Malignancy

Head and Neck Cancer; SCCHN, Oral Cavity; Squamous cell carcinoma of the oral cavity

Stage

Stage 3

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant/Adjuvant

Investigational Agent

IRX-2, cyclophosphamide, indomethacin

Drug Class

Cell-derived cytokine component injection

PI

Boyd Gillespie, MD

Sponsor

IRX Therapeutics

Path

Squamous cell cancer

Key Eligibility Criteria Details
  • Pathologically confirmed Stage II, III, or IVA SCC of oral cavity (excluding lip)
  • Disease surgically resectable with curative intent
  • Karnofsky PS > or = 70%
  • No prior surgery, XRT, or chemo for this disease other than emergency procedure required for supportive care
  • No oropharynx tumor
  • Heme labs wnl
  • PT/PTT <1.4 uln
  • Creatinine clearance >50mL/min
  • No T4b disease as follows:
    • No involvement of pterygopalatine fossa, maxillary sinus, or facial skin
    • No gross extension of tumor to skull base, no pterygoid plate erosion
    • No sphenoid bone or foramen ovale involvement
    • No direct extension to prevertebral fascia
    • No extension to superior nasopharynx or Eustachian tube
    • No direct extension into neck with deep neck musculature involvement
    • No suspected invasion or encasement of carotid arteries
    • No direct extension of neck disease to involve skin
    • No direct extension to mediastinal structures
    • No regional metastases to supraclavicular neck
  • No need for daily immunosuppression (eg. steroids)
  • No need for continued systemic anticoagulation
  • No symptomatic cardiopulmonary disease
  • No prior diagnosis of cancer that has required treatment in last 5 years
  • No prior axillary dissection
LEUKEMIA: CLL; High-risk or Relapsed/Refractory; “CLL-001”

Phase 1/2 study to determine the safety, pharmacokinetics, and efficacy of single agent CC-122 and the combinations of CC-122 and ibrutinib and CC-122 and obinutuzumab in subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma

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Malignancy

Leukemia, CLL, Chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma

Stage

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st line or later for high-risk disease; 2nd line or later for relapsed/refractory disease

Investigational Agent

CC-122

Drug Class

Thalidomide analog/immune effect modulator

PI

Jason Chandler, MD

Sponsor

Celgene

Path

High-risk or relapsed/refractory

Key Eligibility Criteria Details
  • ECOG PS 0-1

  • Age 18-80 years old

  • Must have CLL/SLL requiring treatment per Hallek, 2008

  • Must have at least one clinically measurable lesions defined as

    • Nodal lesion measuring >1.5cm in longest diameter and >1.0cm in longest perpendicular diameter OR

    • Spleen measuring >14cm in longest vertical dimension with a minimum of 2 cm enlargement OR

    • Liver measuring >20 cm in longest vertical dimenstion with a minimum of 2 cm of enlargement OR

    • Peripheral blood B lymphocyte count >5000/uL

  • For single agent and obinutuzumab combo must have relapsed refractory disease as follows:

    • Must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor unless significant co-morbidities or contraindications

  • For ibrutinib combo arm, must have not received prior treatment with ibrutinib or BTK inhibitors and must have high-risk disease defined as follows:

    • 17p- and/or TP53 mutation positive in treatment naïve CLL OR

    • 17p- and/or TP53 mutation positive, and/or complex karyotype and/or progression <24 months after completion of 1st line chemoimmunotherapy in relapsed/refractory CLL

  • Subjects with R/R SLL or CLL with bulky disease (LN>5.0cm) may only be enrolled after discussion with sponsor medical monitor

  • Must have adequate lab values

  • No prior allo or auto SCT within 12 months

  • No known HIV/HBV/HCV

  • No significant peripheral neuropathy

  • No impaired cardiac function

LUNG: Stage 1; Surgery vs. XRT; JOLT: "STABLE-MATES"

JoLT-Ca A randomized phase III study of sublobar resection (SR) versus stereotactic ablative radiotherapy (SAbR) in high risk patients with stage I non-small cell lung cancer (NSCLC), the STABLE-MATES trial

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Malignancy

Lung cancer, Early lung cancer; NSCLC

Stage

Stage 1

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Primary treatment

Investigational Agent

SR vs. SAbR

Drug Class

Surgery vs. XRT

PI

Benny Weksler, MD

Sponsor

University of Texas Southwestern Medical Center

Path

Non-small cell lung cancer

Key Eligibility Criteria Details
  • Radiographic findings c/w and biopsy proven NSCLC
  • Tumor <4 cm maximum diameter (clinical stage IA and selected IB within 60 days of tx)
  • All clinically suspicious mediastinal nodes confirmed negative for cancer histologically
  • Tumor verified by thoracic surgeon to be in a location that will permit sublobar resection
  • Tumor must be peripheral (not touching any surface within 2 cm of proximal bronchial tree)
  • Patient must be at high risk for surgery by meeting 1 major or 2 minor criteria
  • No prior malignancy unless disease free for >3 years (except skin CA and in-situ disease)
  • No evidence of distant mets
  • No prior intrathoracic radiation therapy
  • ECOG PS 0-2
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: METASTATIC: PHASE 1: PD-1 NAIVE: 2nd Line: "PROPEL LUNG"

A Study of a CD122-Biased Cytokine (NKTR-214) in Combination WithAnti-PD-L1 (Atezolizumab) in Patients WIth Metastatic Urothelial Bladder Cancer or Metastatic Non-Small Cell Lung Cancer (PROPEL)

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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 (1st if patient refuses platinum-based therapy)

Investigational Agent

NKTR-214, atezolizumab

Drug Class

pegylated IL-2, PD-L1 inhibitor

PI

Dan Vaena, MD

Sponsor

Nektar Therapeutics

Path

EGFR wild type, ALK normal

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed non-small cell lung cancer lacking EGFR sensitizing mutations and lacking ALK translocation
  • ECOG PS 0-1
  • Measurable disease per RECIST 1.1
  • No prior receipt of immunotherapy with immunomodulators (eg. PD-1 inhibitors, CTLA-4 inhibitors, IDO inhibitors)
  • Either;
    • No more than 1 prior line of platinum-containing therapy with disease progression on or following this therapy OR
    • Patient refuses standard of care therapy in the 1st line
  •  No history of or active autoimmune disease (exceptions include Hashimoto's thyroiditis, Graves' disease, TIDDM, or Med Monitor approval)
LUNG: Metastatic: Phase 1: 2nd line or later: "FRACTION-LUNG IDO/IPI"

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
LYMPHOMA: NHL; DLBCL; Phase 1; "CC-122-DLBCL-001"

A phase 1b, multi-center, open-lable study of novel combinations of CC-122, CC-223, CC-292 and rituximab in diffuse large B-cell lymphoma

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Malignancy

Lymphoma, Diffuse Large B-cell lymphoma, DLBCL

Stage

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>2nd line

Investigational Agent

CC-122 and/or CC-223 and/or CC-292

Drug Class

anti-CRBN (CC-122); mTOR kinase inhibitor (CC-223); BTK ihibitor (CC-292)

PI

Daruka Mahadevan, MD, PhD

Sponsor

Celgene Corporation

Path

Key Eligibility Criteria Details

Biopsy proven DLBCL
Relapsed or refractory to standard treatment
ECOG PS 0-1
Measurable disease
ANC>1.5, plts>50
No CNS involvement
No impared cardiac function
No active tx for diabetes (if on CC-223 arm only)
No prior allo HCT
No auto HCT within 3 months
No systemic anti-cancer tx within 4 weeks_

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; 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

Open to Enrollment

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: 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)
PROSTATE: METASTATIC: CASTRATE RESISTANT: DNA-Repair mutation: "PROfound"

A phase III, open label, randomized study to assess the efficacy and safety of olaparib (Lynparza) versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations (PROfound)

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Malignancy

Prostate cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd (Following failure of one anti-androgen)

Investigational Agent

Olaparib

Drug Class

PARP inihibitor

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Path

Homologous recombination repair deficiency gene mutations: BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L

Key Eligibility Criteria Details
  • Metastatic castration resistant prostate cancer
  • Progression on abiraterone or enzalutamide but not both
  • Prior anti-cancer therapy (e.g. docetaxel) permitted but not required
  • Ongoing therapy with LHRH analog or orchiectomy
  • Qualifying HRR mutation in tumor tissue (see path tab for full complement of qualifying mutations)
  • No prior treatment with PARP inhibitor
  • No prior treatment with platimum or mitoxantrone
  • No known brain metastases
  • No other malignancy within 5 years
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: 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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

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

MOLECULARLY TARGETED: EGFR mut: Metastatic; >/= 2nd line; "My Pathway- EGFR"

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

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Malignancy

y- Peritoneum, Prostate, CNS (brain), stomach (gastric), ovarian, adrenal, biliary tract (bile duct), salivary gland, thyroid, kidney (RCC), urinary tract (bladder), Head and neck (SCCHN), esophagus

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

erlotinib

Drug Class

EGFR inhibitor

PI

VanderWalde

Sponsor

Genentech, Inc.

Path

EGFR activating mutation (not exon 20)

Key Eligibility Criteria Details


Metastatic cancer
EFGR activatingmutation (not exon 20)
NSCLC or pancreatic must not haveexon 19 deletions or exon 21 L858R substitution2nd line or greater
ECOG PS 0-2
No prior treatment with any EGFR inhibitor
No active or untreated CNS metastastasis

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

Ovarian (ovary, ovarian cancer); CNS (brain cancer, central nervous system); Liver (hepatocellular, HCC), Lung (SCLC, NSCLC); Head and neck (SCCHN; oropharynx, larynx, hypopharynx, oral cavity); colon, CRC, (KRAS-mt excluded); pancreatic; breast; gastric

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, amplification, or activating mutation

Key Eligibility Criteria Details


Metastatic solid tumor
HER2 overexpression, amplification, or HER2 activating mutation
Breast, gastric, or GE junction may enter only if HER2 mutation2nd line or greater

No KRAS-mt colorectal cancer

No HER2-mutant lung cancer
ECOG PS 0-2
No prior treatment with any HER-2 directed therapy
No active or untreated CNS metastastasis
LVEF must be>_50%

MOLECULARLY TARGETED: PTCH/SMO mut: Metastatic; >/= 2nd line; "My Pathway- PTCH/SMO"

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

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Malignancy

y- Head and neck (SCCHN, oropharynx, larynx, hypopharyx, oral cavity); liver (hepatocellular, HCC); ovarian; colorectal (colon, CRC); esophageal, CNS (brain), breast, lung

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Vismodegib

Drug Class

Hedgehog inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Path

Hedgehog activation mutations (PTCH loss of function, SMO gain of function)

Key Eligibility Criteria Details


Metastatic solid tumor
Loss of function mutation in PTCH or gain of function mutation in SMO
No basal cell CA, medulloblastoma, or SCLC2nd line or greater
ECOG PS 0-2
No prior treatment with any hedgehogdirected therapy
No active or untreated CNS metastastasis_

MOLECULARLY TARGETED: PIK3CA mutations: "PMT4979g"

An open-label, phase I/II, dose-escalation study evaluating the safety and tolerability of GDC-0032 in patients with locally advanced or metastatic solid tumors or non-Hodgkin's lymphoma and in combination with endorcrine therapy in patients with locally advaned or metastatic hormone receptor-positive breast cancer.

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Malignancy

Bladder, Head and Neck, Gastric, TNBC, Ovarian

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

taselisib (GDC-0032)

Drug Class

PI3 kinase delta inhibitor

PI

Ari VanderWalde, MD

Sponsor

Hoffman-La Roche

Path

PIK3CA mutation

Key Eligibility Criteria Details
  • Advanced solid malignancies with PIK3CA mutations (see "malignancies" tab for current eligible disease states)
  • No  untreated or active CNS mets
  • No diabetes requiring active treatment
  • No active CHF or ventricular arryhtmias requiring treatment
  • Measurable disease via RECIST 1.1
  • ECOG PS 0-1
  • No O2 requirements
  • No XRT within previous 2 weeks (for bony mets) or 4 weeks for all other reasons
  • No requirements for immunosuppression

 

 

 

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

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
  •  
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