Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
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ClinicalTrials.gov Identifier: NCT04793958 |
Recruitment Status :
Recruiting
First Posted : March 11, 2021
Last Update Posted : April 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Colorectal Cancer Metastatic Colorectal Cancer | Drug: MRTX849 Biological: Cetuximab Drug: mFOLFOX6 Regimen Drug: FOLFIRI Regimen | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | March 15, 2021 |
Estimated Primary Completion Date : | September 30, 2023 |
Estimated Study Completion Date : | December 30, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: MRTX849 + Cetuximab |
Drug: MRTX849
28 Day Cycle Biological: Cetuximab 28 Day Cycle
Other Name: Erbitux |
Active Comparator: mFOLFOX6 or FOLFIRI |
Drug: mFOLFOX6 Regimen
Drug: FOLFIRI Regimen
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- Overall Survival (OS) [ Time Frame: 30 months ]Defined as time from date of randomization to date of death due to any cause.
- Progression-free Survival (PFS) [ Time Frame: 30 months ]Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
- Adverse Events [ Time Frame: 30 months ]Defined as number of patients with treatment emergent AEs.
- Objective Response Rate (ORR) [ Time Frame: 30 months ]Defined as the percent of patients documented to have a confirmed CR or PR.
- Duration of Response (DOR) [ Time Frame: 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.
- Patient Reported Outcomes (PROs) [ Time Frame: 30 months ]To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
- Quality of Life Assessment [ Time Frame: 30 months ]To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793958
Contact: Mirati Therapeutics Study Locator Services | 1-844-893-5530 | miratistudylocator@emergingmed.com |

Study Director: | Hirak Der-Torossian, MD | Mirati Therapeutics |
Responsible Party: | Mirati Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT04793958 |
Other Study ID Numbers: |
849-010 KRYSTAL-10 ( Other Identifier: Mirati Therapeutics ) |
First Posted: | March 11, 2021 Key Record Dates |
Last Update Posted: | April 29, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal Cancer Colorectal Cancer Trial Colorectal Carcinoma Rectal Cancer Colon Cancer |
KRAS KRAS G12C RAS Colorectal Adenocarcinoma |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Cetuximab Adagrasib Antineoplastic Agents, Immunological Antineoplastic Agents |