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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06750094

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Amivantamab (biological), Cetuximab (biological), Bevacizumab (biological), 5-fluorouracil (drug)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
700
Started
2024-12-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for colorectal neoplasms
  • • Phase3 - 700 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colorectal neoplasms

Where?

  • • Birmingham - Birmingham Heartlands Hospital
  • • Hull - Castle Hill Hospital
  • • Leeds - St James University Hospital
  • • London - St Bartholomew's Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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 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.

Colorectal Neoplasms

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRASBRAFMSIHER2EGFRMET

Treatment history

Treatments you must have had:

  • ✓ recurrent, unresectable or metastatic disease
  • ✓ of therapy

What the study is looking for

  • ✓Have confirmed by testing a sample adenocarcinoma of the colon or rectum. Participants must have...
  • ✓Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if...
  • ✓Have cancer that can be measured on scans according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  • ✓Have an activity scale (ECOG) performance status (PS) of 0 or 1

Who cannot take part

  • ✗Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab...
  • ✗Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not...
  • ✗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...
See the full 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)

Where Is This Study? (7 UK sites)

Birmingham Heartlands Hospital

Birmingham B9 5ST, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Castle Hill Hospital

Hull HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

St James University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting

University College Hospital

London NW1 2BU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

Recruiting

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09