A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

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.
• 5-fluorouracil — DRUG
  5-fluorouracil will be administered as chemotherapy regimen.
• Leucovorin calcium/Levoleucovorin — DRUG
  Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
• Oxaliplatin — DRUG
  Oxaliplatin will be administered as chemotherapy regimen.
• Irinotecan Hydrochloride — DRUG
  Irinotecan hydrochloride 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) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Key Dates

Start date

Oct 18, 2024

Status verified

Jun 2026

Primary completion

Dec 15, 2028

Completion

Jan 20, 2032

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Amivantamab in Combination With Chemotherapy
  Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) 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 in Combination With Chemotherapy
  Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) 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 4 years and 2 months ]

Central Contacts

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

Locations (79)

Find similar trials in Gilbert, AZ

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