Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Phase 3

Active, not recruiting

• Conditions: Metastatic Colorectal Cancer; Advanced Colorectal Cancer
• Interventions: Drug: MRTX849; Drug: mFOLFOX6 Regimen; Drug: FOLFIRI Regimen; Biological: Cetuximab

• Registration Number: NCT04793958
• Lead Sponsor: Mirati Therapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Study Start: 2021-06-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 461

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRTX849 + Cetuximab	MRTX849	-
mFOLFOX6 or FOLFIRI	FOLFIRI Regimen	-
mFOLFOX6 or FOLFIRI	mFOLFOX6 Regimen	-
MRTX849 + Cetuximab	Cetuximab	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	30 months	Defined as time from date of randomization to date of death due to any cause.
Progression-free Survival (PFS)	30 months	Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	30 months	Defined as the percent of patients documented to have a confirmed CR or PR.
Patient Reported Outcomes (PROs)	30 months	To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
Duration of Response (DOR)	30 months	Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Adverse Events	30 months	Defined as number of patients with treatment emergent AEs.
Quality of Life Assessment	30 months	To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

Trial Locations

Locations (419)

Local Institution - 010-855-E; 🇺🇸 Alabaster, Alabama, United States

Local Institution - 010-855-B; 🇺🇸 Bessemer, Alabama, United States

Local Institution - 010-855-D; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 010-855-A; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 010-855-F; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 010-855-C; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 010-855; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 010-996; 🇺🇸 Gilbert, Arizona, United States

Local Institution - 010-566; 🇺🇸 Goodyear, Arizona, United States

Local Institution - 010-989; 🇺🇸 Phoenix, Arizona, United States

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