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NCT06750094 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Colorectal Neoplasms, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
- 20
- Study locations
NCT06750094: Recruiting Phase 3 study of Colorectal Neoplasms, sponsored by Janssen Research & Development.
NCT06750094 is a Phase 3 study of Colorectal Neoplasms that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 700 participants, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06750094, a Phase 3 study of Colorectal Neoplasms, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- BIOLOGICAL Amivantamab
- BIOLOGICAL Bevacizumab
- DRUG 5-fluorouracil
- DRUG Leucovorin calcium/Levoleucovorin
Study Locations (20)
California
- CBCC Global Research - Bakersfield
- Los Angeles Cancer Network - Glendale
- Cancer and Blood Specialty Clinic - Los Alamitos
- USC Norris Comprehensive Cancer Center - Los Angeles
- UCLA - Santa Monica
- Providence Medical Foundation - Santa Rosa
- Torrance Memorial Physicians Network - Torrance
Florida
- Florida Cancer Specialists South - Fort Myers
- Mount Sinai Medical Center Campus - Miami Beach
- AdventHealth Cancer Institute - Orlando
- Florida Cancer Specialists North Region - St. Petersburg
- Florida Cancer Specialists East - West Palm Beach
Arizona
- Ironwood Cancer and Research Center - Chandler
- Banner MD Anderson Cancer Center - Gilbert
- Arizona Oncology Associates PC NAHOA - Prescott
Arkansas
- St. Bernard's Medical Center - Jonesboro
- Highlands Oncology Group - Springdale
Colorado
- University of Colorado Denver Anschultz Medical Campus - Aurora
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Eastern Connecticut Hematology & Oncology Assoc. - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2024-12-12 |
| Est. Completion | 2029-04-13 |
| Phase | Phase 3 |
What NCT06750094 shows while recruiting
NCT06750094 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 564-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Cetuximab is the first listed.
NCT06750094 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06750094 about?
NCT06750094 is a clinical study titled "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". 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 levoleucovor...
What is the current status of trial NCT06750094?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 700 participants. The study started on 2024-12-12. Estimated completion is 2029-04-13.
What conditions does trial NCT06750094 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT06750094?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Amivantamab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), 5-fluorouracil (DRUG), Leucovorin calcium/Levoleucovorin (DRUG).
Who is sponsoring clinical trial NCT06750094?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06750094 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06750094's enrollment target sits among peer trials
700 8th of 54 higher than 46 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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