Colorectal Neoplasms
Conditions
Interventions
Experimental: Arm A: Amivantamab + FOLFIRI
Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium [folinic acid] or levoleucovorin, and irinotecan)
Sponsors
Yoshinari Nozomi
Eligibility
Sex/Gender
All
Inclusion 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. Local PCR testing (either tissue [preferred] or blood-based) is permitted if NGS cannot be performed (applicable to Japan only) - 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date. [Time Frame: Up to 2 years 1 month] 2. Overall Survival (OS) OS is defined as the time from the date of randomization to the date of participant's death due to any cause. [Time Frame: Up to 4 years 4 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Countries
Australia, Belgium, Brazil, China, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea Republic Of, Malaysia, Mexico, Netherlands Kingdom Of The, Poland, Romania, Spain, Sweden, Taiwan Province Of China, Thailand, Turkiye, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed