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
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Dec 20, 2024
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a new treatment option for patients with colorectal cancer that has not responded to previous chemotherapy. Specifically, it is comparing the effectiveness of a combination of a drug called amivantamab with a standard chemotherapy regimen (known as FOLFIRI) against another combination of treatments that includes cetuximab or bevacizumab along with FOLFIRI. The goal is to see which treatment helps patients live longer without their disease worsening and to determine overall survival rates.
To participate in this study, individuals must be diagnosed with a specific type of colorectal cancer that hasn't been treated successfully before and must have certain genetic characteristics, specifically having wild-type KRAS, NRAS, and BRAF genes. Participants should also have measurable disease and a good performance status, meaning they are generally well enough to engage in normal activities. Throughout the trial, participants will receive close monitoring and care, and they will contribute to important research that may help improve treatment options for future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
- • Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local 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 RECIST v1.1
- • 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
- 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 unlikely 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)
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Baton Rouge, Louisiana, United States
Temple, Texas, United States
Pessac, , France
Bangkok, , Thailand
Hong Kong, , Hong Kong
Cleveland, Ohio, United States
Denver, Colorado, United States
Houston, Texas, United States
Bangkok, , Thailand
Rozzano, , Italy
Mumbai, , India
Kortrijk, , Belgium
Hull, , United Kingdom
London, , United Kingdom
Los Angeles, California, United States
Athens, Georgia, United States
Shatin, , Hong Kong
Kuala Lumpur, , Malaysia
Atlanta, Georgia, United States
Rotterdam, , Netherlands
London, , United Kingdom
Chiang Mai, , Thailand
Taichung, , Taiwan
Taipei, , Taiwan
Kuala Lumpur, , Malaysia
Nashville, Tennessee, United States
Stockholm, , Sweden
London, , United Kingdom
Tainan, , Taiwan
Stockholm, , Sweden
Edegem, , Belgium
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Leeds, , United Kingdom
Chengdu, , China
Szeged, , Hungary
Hattiesburg, Mississippi, United States
Beijing, , China
Shanghai, , China
Guangzhou, Guangdong, China
Petach Tikva, , Israel
Delhi, , India
Pecs, , Hungary
Hangzhou, , China
Beijing, , China
Northwood, , United Kingdom
Lacey, Washington, United States
Leuven, , Belgium
Harbin, , China
Nijmegen, , Netherlands
Pisa, , Italy
Songkhla, , Thailand
Atlanta, Georgia, United States
Gent, , Belgium
Jonesboro, Arkansas, United States
Seoul, , Korea, Republic Of
Taipei, , Taiwan
Tianjin, , China
Chandler, Arizona, United States
Ann Arbor, Michigan, United States
Tel Aviv, , Israel
Santa Monica, California, United States
Omaha, Nebraska, United States
Kuching, , Malaysia
Chihuahua, , Mexico
Anderlecht, , Belgium
Wuhan, , China
Haifa, , Israel
Beijing, , China
Amersfoort, , Netherlands
Orlando, Florida, United States
Nanchang, , China
Daegu, , Korea, Republic Of
Concord, , Australia
Avignon Cedex 9, , France
Suita Shi, , Japan
Jerusalem, , Israel
Chattanooga, Tennessee, United States
Amsterdam, , Netherlands
Kaohsiung City, , Taiwan
Taoyuan, , Taiwan
Gothenburg, , Sweden
Changsha, Hunan, China
Baltimore, Maryland, United States
Padova, , Italy
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Eger, , Hungary
Seoul, , Korea, Republic Of
Madrid, , Spain
Changchun, , China
Barcelona, , Spain
Pamplona, , Spain
Sevilla, , Spain
Fort Myers, Florida, United States
Pune, , India
Bakersfield, California, United States
Istanbul, , Turkey
Atlanta, Georgia, United States
Los Alamitos, California, United States
Tilburg, , Netherlands
Liege, , Belgium
East Brunswick, New Jersey, United States
Norwich, Connecticut, United States
Hangzhou, , China
Tyler, Texas, United States
Ankara, , Turkey
Konya, , Turkey
San Antonio, Texas, United States
Ankara, , Turkey
Adana, , Turkey
Mainz, , Germany
Ipoh, , Malaysia
Shenyang, , China
Udine, , Italy
Puebla, , Mexico
Santa Rosa, California, United States
Sakarya, , Turkey
Brasov, , Romania
Lanzhou, , China
Kaohsiung City, , Taiwan
Georgetown, , Malaysia
Vellore, , India
Torrance, California, United States
Lund, , Sweden
Munich, , Germany
Aurora, Colorado, United States
Ankara, , Turkey
Caxias Do Sul, , Brazil
Hyderabad, , India
Shirley, New York, United States
Nashville, Tennessee, United States
Huizhou, , China
Sao Paulo, , Brazil
Guangzhou, , China
Kashiwa, , Japan
Tokyo, , Japan
Glendale, California, United States
Ankara, , Turkey
Queretaro, , Mexico
Bronx, New York, United States
Chuo Ku, , Japan
Osaka Sayama Shi, , Japan
Tel Aviv Yafo, , Israel
Richmond, Virginia, United States
Grand Rapids, Michigan, United States
Biala Podlaska, , Poland
Putrajaya, , Malaysia
Dallas, Texas, United States
Seoul, , Korea, Republic Of
Jau, , Brazil
Porto Alegre, , Brazil
Osaka City, , Japan
Sao Paulo, , Brazil
Shizuoka, , Japan
Milano, , Italy
Haine Saint Paul La Louviere, , Belgium
Brzozow, , Poland
Bucuresti, , Romania
Kaohsiung, , Taiwan
Barcelona, , Spain
Pittsburgh, Pennsylvania, United States
Beer Yaakov, , Israel
Chiba, , Japan
Berlin, , Germany
Nagoya Shi, , Japan
Guangzhou, , China
Sao Jose Do Rio Preto, , Brazil
Osaka Shi, , Japan
Ramat Gan, Hamerkaz, Israel
Heidelberg, , Australia
South Woodville, , Australia
St Albans, , Australia
Barrio Monacillos, , Puerto Rico
Gdansk, , Poland
Lodz, , Poland
Ganzhou, , China
Uppsala, , Sweden
Gliwice, , Poland
İstanbul, , Turkey
Barretos, , Brazil
Vitoria, , Brazil
Kolkata, , India
Olsztyn, , Poland
Opole, , Poland
Warszawa, , Poland
Frankfurt Am Main, , Germany
Bialystok, , Poland
Miami Beach, Florida, United States
San Juan, , Puerto Rico
Craiova, , Romania
Suita City, , Japan
Poitiers Cedex, , France
Salvador, , Brazil
Guangzhou, , China
Ciudad De Mexico, , Mexico
Guadalajara, , Mexico
Queretaro, , Mexico
Saint Petersburg, Florida, United States
West Palm Beach, Florida, United States
Abilene, Texas, United States
Varanasi, , India
Prescott, Arizona, United States
Mineola, New York, United States
New York, New York, United States
Heidelberg, , Germany
Tijuana, , Mexico
Arlington, Virginia, United States
Penn Wynne, Pennsylvania, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported