Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares petosemtamab plus chemotherapy with cetuximab plus chemotherapy. It is for people with left-sided colon or rectal cancer that cannot be safely removed by surgery or has spread, and has no RAS or BRAF gene changes. Everyone gets cancer treatment; no one gets a placebo.
The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have left-sided colorectal adenocarcinoma, a cancer of the colon or rectum, confirmed by tissue or cell testing.
- The cancer cannot be removed by surgery or has spread to other parts of the body.
- Tumor tissue testing must show no KRAS or NRAS gene changes. A test called next-generation sequencing (NGS) is required; other listed testing methods are not accepted.
- Have not had treatment that travels through the body for cancer that cannot be removed or has spread.
- Be able to receive the assigned chemotherapy: mFOLFOX6 or FOLFIRI.
Who can't join
- Have a BRAF gene change, a known activating HRAS gene change, or other tumor test results ruled out by the study.
- Have MSI-H or dMMR cancer, which means the cancer has problems repairing its DNA.
- Have previously received medicine targeting EGFR, a protein that helps cells grow.
- Have a known complete lack of DPD, a protein that helps break down certain chemotherapy drugs, or gene changes known to cause this.
- If receiving FOLFIRI, have certain combinations of the UGT1A1 *28 or *6 gene versions.
- Have cancer other than colorectal adenocarcinoma.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: * Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic. * Must have documented KRAS and NRAS wild type (wt) colorectal cancer (CRC), as determined by medical record of results from local testing or as assessed by central testing. Local testing must have been conducted in accordance with local guidelines using an Food and Drug Administration (FDA)-approved test or a laboratory-developed test that is validated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States). Next-generation sequencing (NGS)-based test results from tumor tissue are required for determining eligibility. Polymerase chain reaction (PCR)-based tests, sanger sequencing, or pyrosequencing test results are not allowed. * Has not received any prior systemic therapy for unresectable or metastatic CRC. * Must be eligible for treatment with mFOLFOX6 (if assigned to receive mFOLFOX6) or FOLFIRI (if assigned to receive FOLFIRI) according to local regulatory approvals and SOC guidelines. Key Exclusion Criteria: * BRAF mutation, and/or microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) and/or protocol specified tumor status as documented by local test results in the medical record or from central testing or known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available. * Prior exposure to any agents that target epidermal growth factor receptor (EGFR) (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy). * Known complete dihydropyrimidine dehydrogenase (DPD) deficiency or known homozygous/compound heterozygous dihydropyrimidine dehydrogenase gene (DPYD) variants associated with complete loss of DPD activity. Testing for DPD deficiency should be performed per local guidelines. * For a participant who is to receive FOLFIRI: known to be homozygous for the UGT1A1\*28 or \*6 alleles or compound or double heterozygous for the UGT1A1\*28 and \*6 alleles. Testing for UGT1A1 should be done in accordance with local guidelines. * Participants with non-colorectal adenocarcinomatous disease. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Study sites (7)
AR
- Genesis Cancer Center · Hot Springs, AR 71913More trials in Hot Springs
CA
- Valkyrie Clinical Trials - Los Angeles · Los Angeles, CA 90067More trials in Los Angeles
GA
- Low Country Cancer Care Associates_Savannah_1 · Savannah, GA 31405More trials in Savannah
- Central Georgia Cancer Care - Warner Robins Office · Warner Robins, GA 31088More trials in Warner Robins
IN
- Hematology-Oncology of Indiana, P.C. · Indianapolis, IN 46260More trials in Indianapolis
MO
- Oncology Hematology Associates - Springfield_Springfield_2 · Springfield, MO 65807More trials in Springfield
WA
- Vista Oncology · Olympia, WA 98502More trials in Olympia