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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)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Temporarily On Hold

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
SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details
  • Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
    • CDK4/6 inhibitors (abemaciclib, 
    • PI3 kinase blockers (alpelisib,
    • anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib) 
    • anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
    • anti ALK TKIs (ceritinib, crizotinib)
    • MEK inhibitor (combimetinib) 
    • Anti HER2 TKIs (lapatinib, tucatinib)
  • ECOG PS 0-2
  • Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
  • No diarrhea before enrolling on the study (or starting TKI)
  • No ongoing IBS or colitis
  • Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
  • No laxative use within 7 days prior to randomization
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

VIEW TRIAL ON CLINICALTRIALS.GOV
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
ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line (post standard therapy)

Investigational Agent

COM-701, BMS-986207, nivolumab

Drug Class

PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen, Ltd

Path

PVRL2 high (only for basket cohort)

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
  • ECOG PS 0-1
  • Prior therapy with immune therapy are eligible (except in ovarian cohort)
  • In Expansion cohorts patients must either have
    • Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
    • Advanced MSS endometrial cancer
    • A different malignancy that has high expression of PVRL2
  • No active autoimmune disease
  • No interstitial lung disease
  • No active CNS metastases
  • In ovaran cohort, no prior immunotherapy
  • No prior therapy with PVRIG inhibitor or anti-TIGIT antibody
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 SOLID TUMORS: SCLC, GEJ, PDAC, Endometrial: PEN-866-001

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Anal cancer, Pancreatic cancer, PDAC, Cervix, cervical cancer, Gastric cancer, Gastroesophageal cancer, SCLC, Small cell lung cancer, penile, vulvar

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or later

Investigational Agent

PEN-866

Drug Class

HSP-90 inhibitor

PI

Dan Vaena, MD

Sponsor

Tarveda Therapeutics

Path

adenocarcinoma or squamous cell carcinoma

Key Eligibility Criteria Details
  • One of the following malignancies
    • Small cell lung cancer: locally recurrent or metastatic SCLC whose disease has progressed after at least 1 prior line of chemo
    • Gastric or GEJ adenoCA: Disease that has progressed after at least 1 prior line of chemo
    • SCC of genitalia (anus, cervix, vulva, or penis): disease that has progressed after at least 1 prior line (adjuvant counts as prior line)
    • Pancreatic CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
    • Endometrial CA: Disease that has progressed after at least 1 line of prior therapy (adjuvant tx counts as a line if recurrence is within 6 months)
  • ECOG PS 0-1
  • Measurable disease
  • No prior topoisomerase I inhibitor
  • No symptomatic CNS involvement
  • No known HIV/HBV/HCV
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
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)
MOLECULARLY TARGETED: PTCH/SMO mut: Metastatic; >/= 2nd line; \"My Pathway- PTCH/SMO\"

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

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

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

Stage

Stage 4

Phase

Phase 2

Status

Closed to Accrual

Line Of Therapy

Investigational Agent

Vismodegib

Drug Class

Hedgehog inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Path

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

Key Eligibility Criteria Details


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

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
  •  
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

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