West Cancer Center

COLON: ADJUVANT: Treatment based on MRD: NRG-GI008

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

VIEW TRIAL ON CLINICALTRIALS.GOV

Malignancy

Colon

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

FOLFOX vs FOLFIRINOX vs active surveillance

Drug Class

chemo

Noam VanderWalde, MD

Sponsor

NRG

Path

Adenocarcinoma

Key Eligibility Criteria Details

Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
No radiographic evidence of overt metastatic disease
Distal extent of tumor must be greater than or equal to 12cm from the anal verge
Must have had curative resection (en bloc)
Resected tumor specimen and blood must have central testing for ctDNA useing the Signatera assay
Must be microsatellite stable or have intact mismatch proteins
No more than 60 days post surgery to study entry
No other invasive malignancy within 5 years
No known active cardiac 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

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

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).