RightFit
RecruitingPhase 3

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

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

Not stated in the study description — ask the study team about visits and procedures.

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 amivantamab plus FOLFIRI chemotherapy with cetuximab or bevacizumab plus FOLFIRI. It is for people whose colon or rectal cancer has returned, cannot be removed by surgery, or has spread, after prior chemotherapy, and has no certain KRAS, NRAS, or BRAF gene changes. The study measures how long people live and how long their cancer stays from getting worse.

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have adenocarcinoma, a cancer of gland cells, in the colon or rectum, confirmed by tissue or cell tests. The cancer must have returned, be unable to be removed by surgery, or have spread.
  • Have gene tests showing no KRAS or NRAS G12 or G13 changes and no BRAF V600 changes.
  • Agree to provide a new or stored tumor sample taken after the cancer worsened on the most recent treatment, if medically possible.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Have had one round of treatment types for cancer that has spread, using fluoropyrimidine and oxaliplatin chemotherapy. Scans must show the cancer worsened during or after treatment. Prior anti-VEGF treatment, which blocks blood vessel growth, is allowed.

Who can't join

  • Have or have had certain lung inflammation or scarring not caused by infection, or have screening scans that cannot rule it out.
  • Have known allergies, strong reactions, or intolerance to ingredients in amivantamab, cetuximab, bevacizumab, or FOLFIRI.
  • Have or have had another cancer, including one whose course or treatment could affect the study’s safety or treatment results.
  • Have a tumor with dMMR or MSI-H, signs of problems repairing cell DNA, and have not received immunotherapy, a treatment that helps the immune system fight cancer.
  • Have a tumor with too much HER2 protein or extra copies of the HER2 gene.
  • Have previously received irinotecan or medicines that target EGFR or MET, proteins involved in cancer growth.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease * Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing * Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible * Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 * Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy Exclusion Criteria: * Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments * Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor * Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

Study sites (71)

AR

AZ

CA

CO

CT

FL

GA

IA

IL

IN

KS

LA

MD

MI

MO

MS

NE

NJ

NY

OH

OR

PA

TN

TX

VA

WA

WI