Amivantamab and FOLFIRI for Colorectal Cancer

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

Recruiting Phase 3 Interventional Study
Colorectal Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
700 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for people with certain types of colorectal cancer that have come back or spread. Participants will receive either amivantamab combined with chemotherapy or a different combination of treatments.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with colorectal cancer.
  • I have a recurrent, unresectable, or metastatic form of the disease.
  • I have had previous chemotherapy treatment.
  • I have measurable disease.
  • I have a performance status of 0 or 1.
  • My cancer is KRAS/NRAS and BRAF wild type.
  • I agree to provide tumor tissue for testing.

You may not be able to join if

  • I have a history of lung disease or current lung issues.
  • I am allergic to amivantamab, cetuximab, bevacizumab, or FOLFIRI.
  • I have another cancer besides the one being studied.
  • I have mismatch repair deficiency or high microsatellite instability without receiving immunotherapy.
  • I have a HER2-positive tumor.
  • I have previously been treated with irinotecan or certain targeted therapies.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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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…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT