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BILIARY TRACT: METASTATIC: 2nd Line: LEAP-005-Biliary

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Biliary Tract Cancer, Cholangiocarcinoma; Gallbladder cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Biliary Tract Cancer with 1 prior line of therapy
  • Adjuvant therapy only counts as prior line if recurrence within 6 months of completing tx
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
BLADDER: Metastatic: 1st line: Cisplatin Ineligible: HCRN GU15-215

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Atezolizumab and Bevacizumab

Drug Class

PD-L1 Antibody; VEGFR Antibody

PI

Dan Vaena, MD

Sponsor

Hoosier Cancer Research Network

Path

Transitional Cell Carcinoma

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

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Durvalumab, Tremelimumab

Drug Class

PD-L1 antibody, CTLA-4 antibody

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Path

Transitional cell carcinoma

Key Eligibility Criteria Details
  • Unresectable or metastatic transitional cell carcinoma or the urothelium (renal pelvis, ureters, urinary bladder, or urethra)
    • Both transitional cell and mixed transitional/non-transitional cell histologies are permitted
  • No prior 1st line therapy for metastatic disease
    • Prior adjuvant therapy allowed if it has been >12 months since last therapy
    • Prior local intervesical chemo or immune therapy is allowed if at least 28 days before study treatment
  • Either cisplatin-eligible or cisplatin-ineligible but carboplatin eligible patients are allowed
  • Measurable disease
  • ECOG PS 0-1
  • No prior immunotherapy with exception of BCG or antitumor vaccines
  • No autoimmune disease requiring immunosuppression
  • No untreated CNS disease
  • No contraindications to platinum-based doublet chemotherapy
BREAST: NEOADJUVANT: ER+: Post-menopausal: DOD 16-1042

Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer

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Malignancy

Breast cancer, Hormone receptor positive breast cancer, locally advanced BC

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Enzalutamide and fulvestrant

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER positive, HER2 negative

Key Eligibility Criteria Details
  • ER positive breast cancer
  • Tumor stage at least T2
  • Plan to receive local surgery
  • Post-menopausal or if premenopausal will need to have concurrent ovarian suppression
  • ECOG PS 0-2
  • No history of seizures
  • Not on full dose anticoagulation
  • No prior treatment with anti-androgen agents
  • No history of CNS metastases
BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

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

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
  • ER/PR <10%, HER2 negative
  • ECOG PS 0-1
  • ANC >1200, Hgb >10, Plt >100,000
  • Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
  • No T3 or T4 tumors
  • No definitive surgical treatment performed yet
  • No evidence of metastatic disease
  • No prior history of ipsilateral DCIS or breast cancer
  • No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
  • No other malignancies within 2 years prior
  • No active cardiac disease
  • No uncontrolled hypertension
  • No known HIV/HBV/HCV
  • No neuropathy grade >=2
BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"
A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Path

Node positive prior to surgery, pathologically node negative at surgery

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

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

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

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

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

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

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

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

  • ECOG PS 0-1

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

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

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Malignancy

Breast cancer, Invasive breast cancer, BC

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Aduvant

Investigational Agent

Ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER or PR positive (HR+), adenocarcinoma

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

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

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Malignancy

Breast, early breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Path

Key Eligibility Criteria Details

High risk early breast cancer as defined as follows:

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

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

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

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

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Malignancy

Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line chemo

Investigational Agent

Ipatasertib

Drug Class

PI3 kinase inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

Triple negative breast cancer

Key Eligibility Criteria Details
  • Triple negative cancer of the breast, locally advanced or metastatic not amenable to curative resection
  • ECOG PS 0-1
  • Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status by NGS
    • AKT1 missense mutations at E17, L52, or Q79
    • PIK3CA missense mutations at R88, G106, K111, G118, N345, C420, E453, E542, E545, Q546, M1043, H1047, or G1049
    • PTEN homozygous deletion, dominant negative short variant (C124S, G129E, or R130X), less of heterozygosity with copy number 1, double hit 
  • No known brain mets
  • No prior cancers within 5 years
  • No known HIV
  • No cirrhosis
  • No active steroid use (> or = 10mg prednisone/daily)
  • No clinically significant cardiac dysfunction including EF<50%
  • No insulin dependent diabetes
  • No Grade >=2 uncontrolled or untreated hyperlipidemia/hypertriglyceridemia
BREAST: TNBC: 2nd-3rd Line: LEAP-005-TNBC

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or 3rd line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

TNBC

Key Eligibility Criteria Details
  • Have received one or 2 prior lines of therapy
  • Must have been treated with taxane and antrhacycline in the past
  • Adjuvant/neoadjuvant tx not considered line of therapy unless progressed within 6 months
  • LDH <2.0 ULN
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
BREAST: METASTATIC: ER+: Post-menopausal: DOD 16-1001

Phase II trial of fulvestrant plus enzalutamide in ER+/HER2- advanced breast cancer

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Malignancy

Breast Cancer, Metastatic Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (pre-fulvestrant)

Investigational Agent

Enzalutamide

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER+, HER2-

Key Eligibility Criteria Details
  • ER+, HEr2- metastatic breast cacner
  • Candidate for fulvestrant therapy- patients who ahve started fulvestrant may enter if within 3 months of starting fulvestrant
  • ECOG PS 0-2
  • Willing to provide fresh tissue biopsies
  • Post-menopausal. If pre-menopausal will need to receive concurrent ovarian suppression
  • No CNS disease
  • No history of seizures
  • No prior treatment with anti-androgen agent
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: ER/PR+: HER2 neg: No prior taxane: CONTESSA 2

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st line chemo (most likely)

Investigational Agent

tesetaxel

Drug Class

oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER/PR positive, HER2 negative

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

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

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Malignancy

Breast, Metastatic Breast Cancer, MBC,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Tesetaxel

Drug Class

Oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

HER2 negative (Any ER or PR status)

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

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

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Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tesetaxel, nivolumab, pembrolizumab, atezolizumab

Drug Class

oral taxane, PD-1 or PD-L1 inhibitors

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER negative, PR negative, HER2 negative

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

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

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

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

Drug Class

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

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

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

Key Eligibility Criteria Details
  • Triple negative metastatic breast cancer
  • ECOG PS 0-2
  • No prior treatment with any study agents
  • No history of autoimmune disease
  • Presence of measurable disease
  • No symptomatic or untreated CNS disease
BREAST: METASTATIC: ER/PR+: 3rd Line or later: Sacituzumab: IMMU-132-09

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

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Malignancy

Breast, ER positive breast cancer, MBC, PR positive breast cancer, HER2 negative breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd Line or greater

Investigational Agent

Sacituzumab govitecan

Drug Class

ADC for Trop-2

PI

Lee Schwartzberg, MD

Sponsor

Immunomedics, Inc

Path

ER/PR +, HER2-

Key Eligibility Criteria Details
  • Hormone receptor positive, HER2 negative metastatic breast cancer
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic therapies including;
    • At least 1 prior anticancer hormonal treatment
    • At least 1 CDK4/6 in the metastatic settting
  • Eligible to receive at least 1 of the following chemotherapies; eribulin, capecitabine, gemcitabine, vinorelbine
  • Disease progression after most recent therapy
  • No potential therapy available with curative intent (e.g. surgery)
  • No prior Topo1 inhibitors
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

CERVICAL: METASTATIC: FIRST LINE: IMMUNOTX: KEYNOTE 826

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

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Malignancy

Cervical, cervix cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

First line

Investigational Agent

Pembrolizumab

Drug Class

PD-1 antibody

PI

Adam ElNaggar, MD

Sponsor

Merck Sharp and Dohme Corp.

Path

squamous cell, adenosquamous, or adenocarcinoma of cervix

Key Eligibility Criteria Details
  • Persistent, recurrent, or metastatic cervical cancer (squamous cell, adenosquamous, or adenocarcinoma) not amenable to curative treatment
  • No prior treatment with systemic chemotherapy
  • Measurable disease
  • ECOG PS 0-1
  • No known CNS metastases
  • No other malignancy within 3 years (other than NMSC, in situ cancers)
  • No chronic steroid therapy
  • No autoimmune disease
  • No known HBV, HCV, HIV
CHOLANGIOCARCINOMA: Metastatic: Liver dominant disease: Hepatic Perfusion: PHP-ICC-203

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

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Malignancy

Cholangiocarcinoma, bile duct cancer, intrahepatic cholangiocarcinoma

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Melphalan/HDS by percutaneous hepatic perfusion

Drug Class

chemotherapy perfusion

PI

Evan Glazer, MD

Sponsor

Delcath Systems, Inc.

Path

Cholangiocarcinoma

Key Eligibility Criteria Details
  • Intrahepatic cholangiocarcinoma diagnosed by histology
  • Unresectable disease
  • Less than 50% of liver involved
  • No clinically significant extra-hepatic disease (regional nodes 2cm or less are acceptable)
  • ECOG PS 0-1
  • No history of liver transplantation
  • Hepatic vasculature must be compatible with perfusion (prior Whipple is allowed only if anatomy is compatible)
  • No prior radiation therapy to the liver (including Y-90, I-131, etc.)
  • No prior treatment with percutanous trans-arterial treatment to liver (such as TAE or TACE)
  • No Class II or higher CHF
  • No prior malignancy within 5 years except in-situ disease or non-melanoma skin cancer
  • No active HBV or HCV
  • No CNS disease
  • Plts >100, Hgb >10 (independent of transfusions), ANC >1500
  • Bili <1.5x normal, ALT/AST <5x normal 
COLORECTAL: METASTATIC: BRAF mt: 1st Line: ANCHOR

Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

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Malignancy

Colorectal cancer, colon cancer, rectum cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Encorafenib, Binimetinib, Cetuximab

Drug Class

BRAF inhibitor, MEK inhibitor, EGFR antibody

PI

Axel Grothey, MD

Sponsor

Pierre Fabre Medicament

Path

BRAF V600E mutant

Key Eligibility Criteria Details
  • Metastatic colorectal cancer
  • Presence of BRAF V600E mutation in tumor tissue determined by local assay at any time prior to screening
  • No prior therapy for metastatic disease (this trial is a 1st line trial)
  • Measurable disease
  • ECOG PS 0-1
  • No uncontrolled BP (SBP>149 or DBP >99) despite optimal antihypertensives
  • No symptomatic CNS involvement
  • No history of Inflammatory Bowel Disease (IBD) requiring treatment in last 12 months
  • No thromboembolic events, cerebrovascular events, acute coronary snydromes, or CHF in the past 6 months
  • No known contraindication to cetuximab administration
  • No uncontrolled glaucoma, hyperviscosity syndrome, or hypercoagulability syndrome
  • No other malignancy within 3 years (if definitively treated and not recurrent) or 5 years (if not definitively treated)
  • No known HIV/HBV/HCV
COLORECTAL: METASTATIC: RAS/RAF wt: 3rd line: DS8201-A-J203

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

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Malignancy

Colon cancer, rectal cancer, colorectal cancer, CRC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line or greater

Investigational Agent

Trastuzumab deruxtecan (DS8201)

Drug Class

HER2 targeted antibody

PI

Axel Grothey, MD

Sponsor

Daiichi Sankyo, Inc.

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Metastatic or unresectable colorectal cancer.
  • KRAS, NRAS, and BRAF wt
  • Must have at least 1+ on HER2 testing by central vendor
  • Able to provide archival tumor sample
  • ECOG PS 0-1
  • LVEF > or = 50%
  • No surgery or radiation within 4 weeks prior to enrollment
  • No MI within 6 months
  • No symptomatic CHF or elevated troponins within 4 weeks
  • No corneal disease
  • No active CNS mets
  • No other malignancy within 3 years (except solid tumors curatively treated, in situ dz, or non-melanoma skin cancer)
  • No known HIV/HBV/HC
ENDOMETRIAL: RECURRENT OR METASTATIC; 2nd Line: KEYNOTE-775

A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

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Malignancy

Endometrial, Uterine, Uterus, Endometrium

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

pembrolizumab and lenvatinib vs. MD choice

Drug Class

PD-1 inhibitor + VEGFR TKI

PI

Adam ElNaggar, MD

Sponsor

Eisai Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed endometrial carcinoma
  • Radiographic evidence of disease progression after 1 prior platinum-based therapy for metastatic disease
    • Prior adjuvant platinum counts as a prior line if progression occured within 1 year
  • Measurable disease (confirmed by central review)
  • Adequate organ function
  • No significant proteinuria
  • ECOG PS 0-1
  • No carcinosarcoma, leiomyosarcoma or stromal sarcoma
  • No active CNS disease
  • No major blood vessel infiltration
  • No known HIV, HBV, HCV
  • No history of immunodeficiency or chronic immunosuppresant therapy'
  • No active autoimmune disease (except psoriasis) that has required systemic therapy within last 2 years.
ENDOMETRIAL: PHASE-1 (EXPANSION): RECURRENT: LEAP-ENDOMETRIAL

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer

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Malignancy

Endometrial Cancer, Uterus Cancer

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or later

Investigational Agent

DKN-01

Drug Class

DKK1 monoclonal antibody

PI

Adam ElNaggar, MD

Sponsor

Leap Therapeutics

Path

Epithelial endometrial cancer

Key Eligibility Criteria Details
  • Histologically confirmed recurrent epithelial endometrial cancer
    • Patients with germ cell, sex cord stroma, carcinosarcoma, or sarcoma are only eligible if tumor has mixed endometrioid component with documented Wnt signaling alteration
  • Refractory or intolerant to at least one prior standard therapy for metastatic or locally advanced disease
    • Prior chemoradiation is considered a line of therapy
  • Willing to undergo mandatory pre-treatment and on-treatment biopsies
  • ECOG PS 0-1
  • No recent prior malignanciy
  • No symptomatic CNS metastasis
  • No osteoblastic bone mets
GBM: 2nd Line: Pembro-Lenvatinib: LEAP-005-GBM

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Glioblastoma Multiforme, GBM, malignant glioma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

GBM

Key Eligibility Criteria Details
  • Histologically confirmed WHO Grade IV glioblastoma
  • Failed initial systemic tx
  • At least 3 weeks from prior surgical resection
  • At least 6 months from previous radiation unless new area of enhancement outside the 80% isodose line of originial radiation field
  • At least 6 weeks from prior mAbs
  • Has not required escalting doses of steroids or had progression of neurologic symptoms in last 2 weeks
  • No carcinomatous meningitis
  • No extracranial disease
  • No multifocal tumor
  • No recurrent tumor greater than 6cm
  • No intra- or pertumoral hemorrhage greater than grade 1
  • Measurable Disease per RECIST and RANO
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
GASTRIC: METASTATIC: 3rd Line: LEAP-005-Gastric

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Gastric adenocarcinoma, stomach cancer, Gastroesophageal junction cancer, GEJ cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

3rd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Gastric cancer
  • Exactly 2 prior lines of therapy
  • Neoadj or adjuvant tx not considered prior line unless recurrence within 12 months  
  • Maintenance regimens are not considered lines of therapy
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1 - BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
LUNG: NSCLC: METASTATIC: Non-squamous: 1st Line: LEAP-006

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

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Malignancy

Lung cancer, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VGFR antibody, PD-1 antibody

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma, large-cell carcinoma, broncho-alveolar carcinoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed metastatic nonsquamous NSCLC
  • EGFR wt, ALK-wt, ROS1-wt
  • Measurable disease per RECIST 1.1
  • ECOG PS 0-1
  • Adequately controlled BP defined as BP <150/90 with no change in antihypertensive meds within 1 week prior to randomization
  • No known untreated CNS mets
  • No history of pneumonitis that required steroids
  • No major blood vessel invastion or large volume hemoptysis
  • No known HIV/HBV/HCV
  • No active autoimmune disease
  • No prior hypersensitivity to monoclonal antibodies
LUNG 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
MELANOMA: ADJUVANT: STAGE 2: KEYNOTE-716

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

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Malignancy

Melanoma

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp.

Path

Cutaneous

Key Eligibility Criteria Details
  • Stage IIB or IIC Melanoma  (T3b, T4a, T4b). Must be node-negative
  • No prior treatment for melanoma beyond complete surgical resection of current primary lesion
  • Must have received sentinel lymph node biopsy which was negative
  • 12 weeks or less from surgical resection and first study treatment
  • No evidence of metastatic disease on imaging
  • ECOG PS 0-1
  • No known additional malignancy within the past 5 years
  • Must have recovered adequately from surgery
  • No active autoimmune disease requiring systemic treatment in the past 2 years
  • No history of non-infectious pneumonitis
  • No known HIV/HBV/HCV
  •  
MELANOMA: 1st or 2nd line: PD-1 + HSV-virus: RPL-001-16

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

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Malignancy

Melanoma, Skin Cancer, ocular melanoma, mucosal melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st or 2nd

Investigational Agent

RP1 + nivolumab

Drug Class

Oncolytic virus

PI

Ari VanderWalde, MD

Sponsor

Replimune Inc.

Path

Melanoma

Key Eligibility Criteria Details
  • Stage IIIB-IV melanoma, either PD-1 naive or following progression on PD-1 containing regimen
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measruable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
MELANOMA: 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: PHASE-1: RECURRENT: PLAT-REFRACT: wnt pathway mut: P204-OVARIAN

A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer

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Malignancy

Ovarian

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

DKN-01

Drug Class

DKK1 monoclonal antibody

PI

Adam ElNaggar, MD

Sponsor

Leap Therapeutics

Path

Epithelial ovarian cancer, platinum-resistant or refractory

Key Eligibility Criteria Details
  • Currently open cohorts must have documented Wnt signaling alteration
  • Histologically confirmed recurrent platinum-resistant/regractory epithelial ovarian cancer
    • Patients with germ cell, sex cord stroma, carcinosarcoma, or sarcoma are only eligible if tumor has mixed endometrioid component with documented Wnt signaling alteration
  • Refractory or intolerant to at least one prior standard therapy for metastatic or locally advanced disease
    • Prior chemoradiation is considered a line of therapy
  • Willing to undergo mandatory pre-treatment and on-treatment biopsies
  • ECOG PS 0-1
  • No recent prior malignanciy
  • No symptomatic CNS metastasis
  • No osteoblastic bone mets
OVARIAN: 4th Line: Plat-Resistant: LEAP-005

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Ovarian, Primary Peritoneal Cancer, Fallopian Tube

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

4th line (not including maintenance therapies)

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Mer

Path

Ovarian carcinoma

Key Eligibility Criteria Details
  • Ovarian cancer with 3 prior lines of thearpy
  • Neoadjuvant/adjuvant IS considered prior line
  • Maintenance regimens regimens are NOT considered prior line
  • Measurable Disease per RECIST 1.1
  • Archival tissue or newly obtained tissue available
  • ECOG PS 0-1
  • BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
  • No evidence of malabsorption syndrome
  • No evidence of major blood vessel involvement
  • No clinically significant hemoptysis or tumor bleeding
  • No arterial thromboembolism within 12 months
  • No significant CAD within 12 months
  • No prior lenvatinib or checkpoint inhibitor therapy
  • Prior bevacizumab is allowed
  • No proteinuria defined as Uprotein >1g/24 hours
  • LVEF must be 55% or greater
  • No chronic systemic steroid or immunosuppressive therapy
  • No diagnosis of immunodeficiency
  • No active CNS metastases
  • No tumor involving the brain stem
  • No active autoimmune disease that has required treatment within last 2 years
  • No known HIV/HBV/HCV
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
SKIN CANCER: Squamous cell: Adjuvant: KEYNOTE-630

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

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Malignancy

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

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Pembrolizumab

Drug Class

PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Squamous cell skin cancer

Key Eligibility Criteria Details
  • Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
  • Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
  • Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins
  • Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
  • Has completed at least 50 Gray (Gy) 25 fractions of adjuvant RT for LA cSCC prior to study entry
  • Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
  • Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
  • ECOG PS 0-1
  • No other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation, Merkel cell carcinoma; or melanoma
  • No prior immunotherapy
  • Must have recovered from all radiation-related toxicities; must have not required corticosteroids; and has not had radiation pneumonitis
  • No active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • No known HIV/HBV/HCV
SKIN CANCER: Non-melanoma: PD-1 eligible: PD-1 and oncolytic virus: RP-001-16

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

No prior PD-1

Investigational Agent

RP1, nivolumab

Drug Class

oncolytic virus (HSV), PD-1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Replimune, Inc.

Path

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

Key Eligibility Criteria Details
  • Diagnosis of locally advanced or metastatic non-melanoma skin cancer not considered treatable by surgery. Could include;
    • Basal cell carcinoma,
    • Cutaneous squamous cell carcinoma,
    • Merkel cell carcinoma
    • Angiosarcoma of the skin
    • Eccrine carcinoma
    • high grade dermatofibroma protuberans
    • CTCL is NOT allowed
  • Must have exhausted or refused currently available therapy
  • ECOG PS 0-1
  • At least one injectable tumor (visceral or deep nodal lesions may be injectable)
  • Measurable disease by RECIST 1.1
  • No prior oncolytic virus therapy (no prior T-VEC)
  • No active CNS disease
  • No history of major autoimmune disease
  • No known HBV, HCV, or HIV
  • No need for steroids >20mg prednisone daily or equivalent
  • No need for chronic use of anti-virals (e.g. acyclovir)
  • No prior malignancy in past 3 years except locally curable cancers such as non-melanoma skin cancer, or carcinoma in situ.
MOLECULARLY TARGETED: TMB-high: >/=2nd Line: MY PATHWAY- TMB

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

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Malignancy

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 (TMB) high
    • 10 mut/Mb per any CLIA certified test
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
MOLECULARLY TARGETED: 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 ERBB4mt: SUMMIT

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

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Malignancy

Bladder, Breast, 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 (ESCALATION): 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
METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

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