Recruiting NCT06750094

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

Phase III Interventional Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Amivantamab, Cetuximab, Bevacizumab, 5-fluorouracil.
Who it may be relevant to: Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, China +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

Biological Amivantamab
Amivantamab will be administered.
Biological Cetuximab
Cetuximab will be administered.
Biological Bevacizumab
Bevacizumab will be administered.
Drug 5-fluorouracil
5-fluorouracil will be administered as chemotherapy regimen.
Drug Leucovorin calcium/Levoleucovorin
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Drug Irinotecan
Irinotecan will be administered as chemotherapy regimen.

Primary outcome measures

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to 2 years 1 month]
Overall Survival (OS) [Time frame: Up to 4 years 4 months]

Secondary outcome measures (12)

Objective Response Rate (ORR) as Assessed by BICR [Time frame: Up to 4 years 4 months]
ORR as Assessed by Investigator [Time frame: Up to 4 years 4 months]
Progression Free Survival as Assessed by Investigator [Time frame: Up to 4 years 4 months]
Duration of Response (DoR) as Assessed by BICR [Time frame: Up to 4 years 4 months]
Duration of Response as Assessed by Investigator [Time frame: Up to 4 years 4 months]
Time to Response (TTR) as Assessed by BICR [Time frame: Up to 4 years 4 months]
TTR as Assessed by Investigator [Time frame: Up to 4 years 4 months]
Progression Free Survival After Subsequent Therapy (PFS2) [Time frame: Up to 4 years 4 months]
Disease Control Rate (DCR) as Assessed by BICR [Time frame: Up to 4 years 4 months]
Disease Control Rate as Assessed by Investigator [Time frame: Up to 4 years 4 months]
Time to Treatment Failure [Time frame: Up to 4 years 4 months]
Curative Resection (R0) Rate [Time frame: Up to 4 years 4 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment