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

Study on Treatment Options for Advanced Bowel Cancer

Recruiting
18 years or above
All
Phase 3
700 participants needed
7 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colorectal Neoplasms
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  • Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local 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 RECIST v1.1
  • 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

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 unlikely 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)

Updated on 31 Jan 2025. Study ID: NCT06750094

This study investigates treatment options for people with advanced colorectal cancer, specifically those with certain genetic profiles like KRAS, NRAS, and BRAF wild-type. The purpose is to compare how long participants remain free from disease progression and overall survival when treated with investigational medication and chemotherapy versus standard treatments.

Participants will receive either the investigational medication with chemotherapy or standard treatments. Chemotherapy involves drugs that kill or slow the growth of cancer cells. The study aims to understand the effectiveness of these treatments in managing advanced colorectal cancer.

  • Who can participate: Adults with advanced colorectal cancer who have a specific genetic profile (KRAS, NRAS, and BRAF wild-type) and have previously received chemotherapy may be eligible. Participants must have measurable disease and a performance status of 0 or 1.
  • Study details: Participants will need to agree to provide tumor tissue samples if possible.

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