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BILIARY TRACT: METASTATIC: 1st Line: SWOG S1815

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

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Malignancy

Biliary Tract, cholangiocarcinoma, gallbladder cancer, bile duct cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

nab-paclitaxel

Drug Class

taxane

PI

Axel Grothey, MD

Sponsor

Southwest Oncology Group (SWOG)

Path

biliary carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
  • Must have metastatic or unresectable disease and no prior therapy for metastatic disease
  • Does not need to be measurable disease
  • No ampullary cancer
  • No adjuvant therapy within 6 months prior to registration
  • ECOG PS 0-1
  • No other prior malignancy within 2 years
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: ENFORTUMAB VEDOTIN: SGN22E-003

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer 

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Malignancy

Bladder Cancer, Urothelial carcinoma

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st Line

Investigational Agent

Enfortumab Vedotin and Pembrolizumab

Drug Class

ADC, PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Seattle Genetics, Inc.

Path

Transitional cell carcinoma

Key Eligibility Criteria Details
  • Unresectable locally advanced or metastatic urothelial carcinoma
  • Measurable disease
  • No prior systemic therapy for metastatic urothelial carcinoma with following exceptions
    • May have received neoadjuvant chemo with recurrence >12 months from completion of therapy
    • May have received adjuvant chemo with recurrence >12 months from completion of therapy
  • Must be eligible to receive platinum based chemotherapy
  • ECOG PS 0-2
  • No CNS metastases
  • No known HBV, HCV, or HIV
  • No other malignancy within 3 years before study drug
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
MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ROS1 fusion. Any cancer type except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • ROS1 gene fusion positivity
  • No non-small lung cancer (NSCLC)
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: PIK3CA Mutations: myTACTIC Arm B

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmB: GDC-0077 in patients with PI3K activating mutation-positive tumors

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Malignancy

Breast, Lung (NSCLC), Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

GDC-0077

Drug Class

PI3K p110 alpha inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PIK3CA mutation positive. Any malignancy except NOT CNS tumors

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No primary CNS malignancy
  • One of the following PIK3CA mutations:
    • R88Q
    • ​G106A/D/R/S/V
    • K111N/R/E
    • G118D
    • N345D/H/I/K/S/T/Y
    • C420R
    • E453A/D/G/K/Q/R/V
    • E542A/D/G/K/Q/R/V
    • E545A/D/G/K/L/Q/R/V
    • Q546E/H/L/P/R
    • M1043I/T/V
    • H1047D/I/L/M/P/Q/R/T/Y
    • G1049A/C/D/R/S
    • Others only with study medical monitor approval
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No anti-hyperglycemic medication (no treated T2DM or T1DM)
MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Not Non-small cell lung cancer (NO NSCLC)
  • ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PTEN loss or loss of function

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
  • PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No insuline dependent diabetes
MOLECULARLY TARGETED: AKT mutation: myTACTIC Arm D(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

select AKT mutations

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • One of the following mutations in AKT:
    • ​AKT 1 : E17K, L52R, or Q79K
    • AKT 2 : E17K
    • AKT 3: E17K, L51R, or Q78K
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No insulin dependent diabetes
MOLECULARLY TARGETED: TMB high: myTACTIC Arm E(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line but cannot have previously had PD-1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

TMB high, defined as > or = 10 mutations/megabase

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Tumor mutational burden-high (TMB-H) determined by CLIA opr quivalently certified assay, via tissue or blood
  • No prior treatment with anti-PD1 or anti-PD-L1 agents
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: MSI-h/dMMR: myTACTIC Arm E(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior anti-PD-1 or anti-PD-L1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

MSI-h or dMMR

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
  • No prior treatment with anti-PD1 or anti-PD-L1 agents
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: HER2/ERBB2 amplification or mutation: myTACTIC Arms F/G/H/I

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm F: Trastuzumab emtansine plus atezolizumab   Arm G: PH FDC SC  Arm H: PH FDC SC plus chemotherapy Arm I: trastuzumab emtansine plus tucatinib, in patients with ERBB2 gene amplification- or mutation-positive tumors.

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior

Investigational Agent

TDM-1 with atezolizumab, or PH FDC SC with or without chemotherapy, or TDM-1 with tucatinib

Drug Class

Anti-HER2 agents

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB2 amplification or specific mutation

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • ​TMB must be <10 mutations/megabase
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: HER2/ERBB2 amp or mut; TMB-h: myTACTIC Arm J

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Lung, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

TD-M1 + atezolizumab

Drug Class

anti-HER2 agent and anti-PD-L1 agent

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB amplificaiton or mutation AND TMB-h or MSI-h or dMMR

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • No breast cancer (breast cancer is excluded)
  • Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
  • Any of the following ERBB2 mutations:
    • 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896C​​G
  • Must ALSO have one of the following alterations
    • ​TMB > or =10 mutations/megabase
    • MSI-h
    • dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No active autoimmune disease
MOLECULARLY TARGETED: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

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

Key Eligibility Criteria Details
  • Metastatic or surgically unresectable solid tumor
  • Measurable disease
  • Documentation of an FGFR1-3 gene mutation or translocation
  • At least 1 prior line of therapy with progression
  • No other therapy available likely to provide clinical benefit
  • ECOG PS 0-2
  • No other FGFR inhibitors within last 6 months
  • No clinically significant corneal or retinal disorder
  • No untreated CNS disease (except primary brain cancer)
  • No additional malignancy at current time requiring active treatment
  • No history of calcium or phosphate disorder or systemic mineral imbalance
  • No clinically significant cardiac disease
  • No active HBV/HCV
  • No known HIV
MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

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

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Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

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

Key Eligibility Criteria Details
  • Histologically confirmed cancer for which no curative therapy exists
  • Documented HER2 (ERBB2) or HER4 (ERBB4)  mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
    • Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
  • At least one measurable or evaluable lesion
  • LVEF >/=50%
  • ECOG PS 0-2
  • No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
  • No symptomatic or unstable brain mets (stable are allowed)
  • No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
  • No uncontrolled cardiac disease
  • No chronic diarrheal disorder
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

Closed to Accrual

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 SOLID TUMORS: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details
  • Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
  • Must not be eligible for curative resection
  • Must be positive for at least 1 of the following human leukocyte antigens:
    • HLA-A*02:01
    • HLA-A*02:06
    • HLA-A*24:02
    • HLA-A*03:01
    • HLA-B*15:01
  • ECOG PS 0-1
  • No known CNS mets
  • No known HIV/HBV/HCV
ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

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

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

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

VIEW TRIAL ON CLINICALTRIALS.GOV
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 SOLID TUMORS: Phase 1: Immunotherapy Combination: \"NIVO-GITR\"

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd line or later

Investigational Agent

BMS-986156 and nivolumab

Drug Class

GITR agonist, anti-PD-1 antibody

PI

Greg Vidal, MD

Sponsor

Bristol-Myers Squibb

Path

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

Key Eligibility Criteria Details
  • Measurable disease

  • NSCLC

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

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

  • Cervical Cancer

    • Persistent, recurrent, or metastatic disease

    • Squamous, adenosquamous or adenocarcinoma histology

    • At least one prior platinum based regimen

    • Confirmation of HPV status

  • Bladder cancer

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

    • Minor histologic variants are acceptable

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

  • SCCHN

    • Must have documented HPV status and subtype

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

    • Cannot be amenable to local therapy with curative intent

  • Ovarian

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

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

  • HCC

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

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

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

    • No clinical ascites or variceal bleeding

  • No more than 5 prior lines of treatment

  • Acceptable lab parameters

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

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

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

BLADDER: Metasatatic: 1st Line: Immunotherapy: "D419BC00001"
A phase III, open-label, controlled, multi-center, global study of first-line MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus standard of care chemotherapy in patients with unresectable stage IV urothelial bladder cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder Cancer, First Line Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma of Bladder

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st Line

Investigational Agent

Durvalumab (MEDI4736) and Tremelimumab

Drug Class

Anti PD-L1 and Anti-CTLA-4

PI

Brad Somer, MD

Sponsor

AstraZeneca

Path

Transitional Cell Carcinoma

Key Eligibility Criteria Details
  • Unresectable Stage IV transitional cell carcinoma of the urothelium
  • No previous treatment in metastatic setting
  • PD-L1 status to be determined centrally prior to randomization
  • No prior anti-CTLA or anti PD-1 agents
  • No CNS involvement
  • No active or prior autoimmune disease
  • No HIV, HBV, HCV
BLADDER: Metastatic: 2nd Line: Phase 1; "D4884C00001 UBC"
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder, Second Line Metasatic Bladder Cancer

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd

Investigational Agent

Tremelimumab (and Durvalumab)

Drug Class

anti CTLA-4 antibody (and anti PD-L1 antibody)

PI

Ari VanderWalde, MD, MPH

Sponsor

AstraZeneca

Path

Urothelial bladder cancer

Key Eligibility Criteria Details
  • Metastatic urothelial bladder cancer
  • Failed (or intolerant to) exactly one line of prior therapy for metastatic disease, which must have contained platinum
  • Prior surgery, radiation,and neoadj/adj chemo are permitted
  • Measurable disease
  • No active CNS disease
  • No history of leptomeningeal disease
  • No documented autoimmune or inflammatory disorders
ADVANCED TUMORS: Metastatic; PD-1 monotherapy; “Checkmate 627”

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

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

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Bristol-Myers Squibb

Path

tumor type specific

Key Eligibility Criteria Details
  • Measurable disease required
  • ECOG PS <1
  • Brain mets allowed but must not be active, cannot require steroids, have at least one measurable lesion outside of brain
  • Excluded tumors:
    • No Pancreatic
    • No endometrial with ER>10%
    • No ovarian
    • No breast
    • No esophageal
    • No gastric
    • No glioma
    • No hepatocellular carcinoma
    • No lymphoma (except primary CNS lymphoma)
    • No leukemia
    • No melanoma
    • No MDS
    • No lung cancer
    • No renal cell
    • No bladder
  • Must not have had other cancer within 2 years
  • No prior PD-1/L-1 or CTLA-4 therapy
  • No autoimmune disease
  • No active steroids
  • No known HIV, HBV, or HCV
  • See "malignancy" list for accepted tumor types
ADVANCED SOLID TUMORS: Phase 1; "I3Y-MC-JPBE"
Effects of CYP3A inhibition by clarithromycin on the pharmacokinetics of LY2835219 and its metabolites in cancer patients VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

LY2835219

Drug Class

CDK 4/6 Inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Eli Lilly and Company

Path

Any solid tumor

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

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd line or greater

Investigational Agent

Alectinib

Drug Class

ALK inhibitor

PI

Ari VanderWalde

Sponsor

Genentech, Inc.

Path

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

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

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

> or equal to 2nd line

Investigational Agent

Vemurafenib and Cobimetinib

Drug Class

BRAF inhibitor + MEK inhibitor

PI

VanderWalde

Sponsor

Genentech, Inc.

Path

BRAF activating mutation

Key Eligibility Criteria Details


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

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

VIEW TRIAL ON CLINICALTRIALS.GOV
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

Closed to Accrual

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: 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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

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%
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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2ndline or later

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech

Path

Solid tumor

Key Eligibility Criteria Details
  • PD-L1 copy number gain/amplification (likely available on Foundation only)
  • Patients with MSI-high
    • Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
  • Patients with dMMR
    • Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
  • Patients with total mutational burden (TMB) high
    • 10 mut/Mb per any CLIA certified test
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
ADVANCED SOLID TUMORS; Phase 1; BRAF mutation; "113773"
A study to evaluate the effect of repeat oral dosing of GSK2118436 on cardiac repolarization in subjects with V600 BRAF mutation-positive tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

PI

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Path

BRAF mutation

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

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

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

Any, following prior participation on GSK BRF study

Investigational Agent

Dabrafenib

Drug Class

BRAF inhibitor

PI

Jason Chandler, MD

Sponsor

GlaxoSmithKline

Path

BRAF mutation

Key Eligibility Criteria Details
Currently participating in a trial of dabrafenib
No evidence of progressive disease on dabrafenib
No permanentdiscontinuation of dabrafenib for toxicity
No unresolved toxicity of grade 2 or higher
LVEF >50% at transition to this study
QTc <480 ms
No CHF
SUPPORTIVE CARE: CINV: HEC: 1st Line: "NEPA-15-18"
A phase 3 multicenter, randomized, double-blind, active control study to evaluate the safety and efficacy of IV pro-netupitant/palonosetron (260mg/0.25mg) combination for the prevention of chemotherapy-induced nausea and vomiting in repeated chemotherapy cycles in patients receiving highly emetogenic chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

x- HEC for breast cancer, head and neck cancer, hematologic malignancies, leukemia, lymphoma, lung cancer, bladder cancer

Stage

N/A

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

1st Line (Prior targeted or endocrine therapy allowed)

Investigational Agent

IV Pro-Netupitant/Palonosetron Fixed Dose Combination

Drug Class

Fixed dose combination NK1 antagonist + 5-HT3 antagonist

PI

Lee Schwartzberg, MD

Sponsor

Helsinn Healthcare SA

Path

Any

Key Eligibility Criteria Details
  • Naïve to cytotoxic chemotherapy (endocrine or targeted therapy allowed)
  • Scheduled to receive at least 4 repeated consecutive cycles with one of the following reference HEC (alone or in combination with other chemo agents) on Day 1
    • Cisplatin as single IV dose >70mg/m2
    • Cyclophosphamide >1500mg/m2
    • Carmustine (BCNU) >250 mg/m2
    • Dacarbazine (DTIC)
    • Mechloretamine (nitrogen mustard)
  • ECOG PS 0-2
  • Adequate laboratory values
  • Cannot be scheduled to receive MEC or HEC on Day 2-5 of a cycle
  • No active nausea of vomiting in 24 hours prior to chemo
  • No symptomatic CNS disease
  • No systemic steroids within 3 days of HEC
  • No anti-emetic medicine within 24 hours of HEC
ADVANCED TUMORS: Metastatic: Immunotherapy combination: ≥2nd line: “Keynote-037”

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

≥2nd line

Investigational Agent

Epacadostat and Pembrolizumab

Drug Class

IDO inhibitor and PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Incyte Corporation

Path

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

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • Fresh baseline tumor biopsies are required unless med monitor approval
  • No active ILD or pneumonitis
  • No active receipt of steroids within 7 days or known immunodeficiency
  • No prior anti-PD-1 or CTLA-4 treatment
  • No known or active CNS mets
  • No history of autoimmune disease
  • For MSI-high CRC
    • MMR or MSI status is, respectively, determined by examining either CRC tumor: protein expression by IHC of 4 MMR enzymes (MLH1/MSH2/MSH6/PMS2) or 3 to 5 tumor microsatellite loci using PCR-based assay. Tumors are classified as MSI high when at least 2 allelic shifts among the 3 to 5 analyzed microsatellite markers are detected by PCR or absence of at least 1 of 4 MMR protein expression is detected by IHC
  • For Gastric cancer (COHORT CLOSED)
    • Must have documentation of HER2 status. IF HER2+ must have progressed or been intolerant of HER2 directed therapy
    • No more than 2 prior lines of therapy
  • For Hepatocellular carcinoma
    • Must be Child-Pugh Class A
    • Must be Barcelona Clinic Liver Cancer Stage C disease (or Stage B disease and either refractory to or not amenable to locoregional therapy
    • No more than 2 lines of prior therapy
    • Must have progressed on or intolerant to sorafenib
    • No history of liver transplant, clear invasion of bile duct or main portal branch, hepatorenal syndrome, or required esophageal variceal ablation within 28 days of study start
    • HBV/HCV only allowed if meet certain criteria
  • For melanoma- (COHORT CLOSED)
    • Known BRAF status
    • No ocular melanoma
  • For bladder/transitional cell (COHORT CLOSED)
    • TCC of bladder, ureter, or renal pelvis
    • 2nd line after progression on platinum (if no platinum received must have documented why unable to tolerate)
  • For RCC (COHORT CLOSED)
    • Clear cell histology
    • Following progression on therapies with established clinical benefit
  • For NSCLC (COHORT CLOSED)
    • 2nd line or later after platinum based therapy for metastatic disease
    • If EGFR or ALK positive, must have received targeted therapy
    • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
  • For SCCHN (COHORT CLOSED)
    • No nasopharyngeal, salivary gland, or non-squamous histology
    • 2nd line or later after failure of platinum-based therapy
    • If progressed within 6 months of adjuvant therapy, OK to enroll 1st line
  • For DLBCL
    • No prior allo transplants
    • 2nd line or later
    • Not a candidate for curative tx or SCT
  •  
BLADDER; Metastatic; 2nd-line; PD-1 inh; "KEYNOTE-045"
A phase III randomized clinical trial of pembrolizumab (MK-3475) versus paclitaxel, docetaxel, or vinflunine in subjects with recurrent or progressive metastatic urothelial cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder cancer, urothelial carcinoma, renal pelvis, ureter, urethra

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

2nd line

Investigational Agent

Pembrolizumab (MK-3475)

Drug Class

PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Merck Sharp & Dohme Corp.

Path

transitional cell or mixed transitional/non-transitional with predominant transitional component

Key Eligibility Criteria Details

Predominantly transitional cell urothelial carcinoma of bladder, renal pelvis, ureter, or urethra
Recurred or progressed following platinum-based chemotherapy

Measurable disease
No more than 2 prior lines of systemic�therapy (including adjuvant)
Willing to provide tissue (archived if available, new bx otherwise)
ECOG PS 0-2
No CNS mets
No active autoimmune disease
No active cardiac disease
No interstitial lung dz or non-infectious PNA
No HIV, HBV, or HCV

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)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bladder, Transitional Cell Carcinoma, TCC, Urothelial Carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

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)
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)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Lung, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

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)
ADVANCED SOLID TUMORS: Phase 1; FGFR Positive; "CBGJ398"
A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignancies____ VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

z- Advanced Solid Tumors, Bladder Cancer, Squamous Lung Cancer

Stage

Stage 2

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

last (no further standard therapy),>3rd

Investigational Agent

BJG398

Drug Class

FGF-R (fibroblast growth factor- receptor) kinase inhibitor

PI

Gary Tian, MD

Sponsor

Novartis

Path

FGFR1�or FGFR2 amplification positive (+)or FGFR3 mutation positive__ (+)

Key Eligibility Criteria Details


FGFR1�or FGFR2 amplification positive (+)
� � � � �or FGFR3 mutation positive__ (+)
No CNS involvement.�
No current corneal disorder/keratophathy.�
Normal calcium/phosphate homeostasis
Normal cardiac function (by echo/MUGA)__

MOLECULARLY TARGETED: Metastatic; >/= 2nd line; FGFR mutation; "SIGNATURE CBGJ398XUS04"
Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6- BGJ398 for patients with tumors with FGFR genetic abnormalities VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

BGJ398

Drug Class

FGFR inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

FGFR genetic alteration

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: Metastatic: >/=2nd line; P2P: "SIGNATURE CBKM120ZUS40"
Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 1 - BKM120 for patients with PI3K-activated tumors VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

y- Advanced Cancer; Head and Neck (SCCHN), Non-Hodgkin Lymphoma (NHL), Ovarian, Bladder (Urothelial), Cervical, Liposarcoma, Adenoid Cystic

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

BKM120

Drug Class

PI3K inihibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

PI3K activation (PI3K mutation, PTEN mutation, loss of PTEN, PI3K amplification, or loss-of-function mutation of PI3KR1)

Key Eligibility Criteria Details
One (or more) of following abnormalities:
PI3K mutation, deletion, or amplification
PTEN mutation
Loss of function of PI3KR1
None of the following malignancies:
CRC, NSCLC, breast, prostate, endometrial, GMB
At least one prior line of therapy
No standard options anticipated to provide benefit
ECOG 0-1
No CNS mets
No significant mood disorder

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

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/= 2nd line

Investigational Agent

Ceritinib

Drug Class

ALK inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

ALK or ROS1 mutation, translocation, rearrangement, or amplification

Key Eligibility Criteria Details

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

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

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

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

No further standard therapies

Investigational Agent

LEE011

Drug Class

CDK4/6 Inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

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

Key Eligibility Criteria Details

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

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

MEK162

Drug Class

MEK 1/2 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

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

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

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

>/=2nd line

Investigational Agent

Dovitinib (TKI258)

Drug Class

Angiogenesis inhibitor

PI

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Path

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

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


FGFR 1/2/3, FLT3, cKIT,VEGFR 1/2, RET,
TrkA (NTRK1),PDGFRa/b,CSF-1R_
None of the following tumors:
Breast
RCC (kidney/renal)
Bladder
HCC (hepatocellular)
Endometrial
Squamous NSCLC
Heme malignancies (exceptFLT3 AML and MM)
At least one prior therapy for disease
ECOG 0-1
No brain mets
No anticoagulation
Bladder: Metastatic: Phase I: 2nd Line: FIERCE-22

A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 1

Status

Closed to Accrual

Line Of Therapy

2nd Line

Investigational Agent

vofatamab, pembrolizumab

Drug Class

FGFR3 inhibitor, PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Rainier Therapeutics

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 progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Have measurable disease according to RECIST v1.1.
  • Has available archival tumor or is willing to undergo diagnostic biopsy at screening
  • ECOG PS 0-1
  • 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 CNS disease or any history of brain metastases
  • No autoimmune disease
  • No history of significant coagulation or platelet disorder in last 12 months
BILIARY TRACT; Metastatic; 2nd Line; "SPI-1620-12-202"
Phase II study of SPI-1620 in combination with docetaxel as a second-line treatment for patients with advanced biliary cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Bile Duct, Gallbladder, Biliary Tract

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

2nd

Investigational Agent

SPI-1620

Drug Class

Endothelin B (ETB) agonist

PI

David Portnoy, MD

Sponsor

Spectrum Pharmaceuticals

Path

Key Eligibility Criteria Details

Histologically confirmed biliary tract or gallbladder cancer
Failure of one prior gemcitabine-based chemo regimen
ECOG PS 0-2
No uncontrolled CNS mets
No significant circulatory disorders in last 6 months
No conmed of phosphodiesterase inhibitor
No high-grade baseline peripheral neuropathy
PROSTATE: Non-metastatic; high-risk; anti-androgen; "SPARTAN"
A multicenter, randomized, double-blind, placebo-controlled, phase III study of ARN-509 in men with non-metastatic (M0) castration-resistant prostate cancer VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate cancer, non-metastatic, castrate resistant prostate, CRPC, PSA recurrent

Stage

Stage 4

Phase

Phase 3

Status

Closed to Accrual

Line Of Therapy

After failure of ADT

Investigational Agent

ARN-509

Drug Class

Anti-androgen

PI

Brad Somer, MD

Sponsor

Aragon Pharmaceuticals

Path

Adenocarcinoma. No neuroendocrine differentiation or small cell features.PSA doubling time of <10 months

Key Eligibility Criteria Details

Adenocarcinoma without neuroendocrine or small cell features
PSADT of < /=10 months (3 rising values during ADT, last >2ng/ml)
No evidence of metastasis (pelvic nodes up to 2cm allowed)
Castrate levels of testosterone x 4 weeks prior
Stable doses of bone resorptive agents x4 weeks prior
No anti-androgen x 4 weeks prior (ie. bicalutamide)
No surgery x 4 weeks prior
ECOG PS 0-1
No prior tx with 2nd gen anti-androgens
No hx of seizures
No prior malignancy (except skin and superficial bladder) within 5 years
No cardiac disease within 5years

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