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

Conditions

• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amivantamab — BIOLOGICAL
  Amivantamab will be administered.
• Cetuximab — BIOLOGICAL
  Cetuximab will be administered.
• Bevacizumab — BIOLOGICAL
  Bevacizumab will be administered.
• 5-fluorouracil — DRUG
  5-fluorouracil will be administered as chemotherapy regimen.
• Leucovorin calcium/Levoleucovorin — DRUG
  Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
• Irinotecan — DRUG
  Irinotecan will be administered as chemotherapy regimen.

Study Details

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.

Key Dates

Start date

Dec 12, 2024

Status verified

Jun 2026

Primary completion

Dec 15, 2027

Completion

Apr 13, 2029

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Amivantamab + FOLFIRI
  Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium \[folinic acid\] or levoleucovorin, and irinotecan) as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
• Active Comparator: Arm B: Cetuximab or Bevacizumab + FOLFIRI
  Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

Primary Outcome Measure

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

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (70)

Find similar trials in Chandler, AZ

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