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COLORECTAL: METASTATIC: 1st LINE: KRAS mutant: CRDF-004

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Onvansertib

Drug Class

Polo-like kinase 1 inhibitor

PI

Brad Somer, MD

Sponsor

Cardiff Oncology

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Metastatic CRC
  • Documented KRAS or NRAS mutation
  • No prior systemic therapy in metastatic setting
  • ECOG PS 0-1
  • No BRAF mutation, no MSI-h
  • No prior treatment with VEG-F inhibitor
  • No DPD dficiency
  • No untreated or symptomatic CNS mets
COLON: METASTATIC: BRAFmt: MSI-h: 1st Line: SEAMARK

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colon cancer, rectal cancer, colorectal cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

encorafenib, cetuximab, pembrolizumab

Drug Class

BRAF inhibitor, EGFR mAb, PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Pfizer

Path

BRAF V600 mutant, MSI-h, dMMR

Key Eligibility Criteria Details
  • Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
  • Locally confirmed BRAF V600E mutation in tumor tissue or blood
  • ECOG PS 0 or 1
  • Have not received prior systemic regimens for metastatic disease.
  • Measurable disease
  • RAS wt
  • No known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
  • No immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
  • No presence of acute or chronic pancreatitis
  • No previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
  • No previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
COLORECTAL: METASTATIC: 3rd Line: cMET+: M24-064

AndroMETa-CRC-064 Abbvie M24-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd or later

Investigational Agent

ABBV-400

Drug Class

Anti-cMET ADC

PI

Axel Grothey, MD

Sponsor

Abbvie

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Histologically or cytologically confirmed unresectable metastatic adenocarcinoma of the colon or recturm
  • Has already received the following regimens for advanced colorectal cancer and has demonstrated PD or intolerance to their last regimen
    • Must have included a fluoropyrimidine, irinotecan, oxaliplatin, and an anti-VEGF monoclonal antibody, as well as an anti-EGFR antibody if indicated
    • Patients who received adjuvant therapy and had recurrence within 12 months can count the therapy as one regimen of therapy for advanced disease
    • No prior lonsurf
    • Patients with MSI-h/dMMR or BRAF mt should have received appropriate therapy
  • Measurable disease
  • ECOG PS 0-1
  • EF >50%
  • No untreated CNS disease
  • No bevacizumab bleeding risks
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