A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Mirati Therapeutics Inc.
- Enrollment
- 461
- Locations
- 419
- Primary Endpoint
- Progression-free Survival (PFS)
Study Overview
Brief Summary
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Exclusion Criteria
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- Active brain metastasis
Arms & Interventions
MRTX849 + Cetuximab
Intervention: MRTX849 (Drug)
mFOLFOX6 or FOLFIRI
Intervention: mFOLFOX6 Regimen (Drug)
mFOLFOX6 or FOLFIRI
Intervention: FOLFIRI Regimen (Drug)
MRTX849 + Cetuximab
Intervention: Cetuximab (Biological)
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: 30 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Time Frame: 30 months
Defined as time from date of randomization to date of death due to any cause.
Secondary Outcomes
- Objective Response Rate (ORR)(30 months)
- Patient Reported Outcomes (PROs)(30 months)
- Duration of Response (DOR)(30 months)
- Adverse Events(30 months)
- Quality of Life Assessment(30 months)
Investigators
Study Sites (419)
Identifiers
- NCT ID
- NCT04793958
- Other Study IDs
- CA239-0006, KRYSTAL-10, CA239-0006, 849-010
Dates
- First Submitted
- (5 years ago)
- First Posted
- (5 years ago)
- Primary Completion
- (8 months ago)
- Study Completion
- (in 22 days)
- Last Verified
- (29 days ago)
- Last updated
- (2 days ago)
Regulatory & Sharing
- FDA Regulated Drug
- Yes
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html