West Cancer Center

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

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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

COLORECTAL: METASTATIC: 1ST LINE: BRAF MT: BREAKWATER

An open-label, multicenter, randomized Phase 3 study of first-line encorafenib plus cetuximab with or without chemotherapy versus standard of care therapy with a safety lead-in of encorafenib and cetuximab plus chemotherapy in participants with metastatic BRAF V600E-mutant colorectal cancer

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Malignancy

Colon, Rectum, Colorectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Encorafenib, cetuximab

Drug Class

BRAF inhibitor, EGFR antibody

PI

Sponsor

Pfizer

Path

Key Eligibility Criteria Details

Age 16 or greater
Histologically or cytologically confirmed Stage IV CRC
Must contain a BRAF V600E mutation on local (FMI or Caris) or central testing
No prior systemic treatment in metastatic setting
Prior adjuvant or neoadjuvant therapy is OK only if relapse/metastasis is 6 months or greater from the end of the neo/adjuvant treatment
No history of acute or chronic pancreatitis
No symptomatic brain mets
Must have measurable disease

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

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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).