Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Amivantamab: 1600 mg (BW less than 80 kg) or
2240 mg (BW greater than equal to 80 kg)
Route: SC
Cycle 1: weekly administration
Cycles 2 onwards: biweekly administration
Control Inte
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants can only be included in this study if they meet the following criteria: 1. Have been diagnosed with left-sided colorectal cancer through lab tests or tissue samples. 2. Have been diagnosed with KRAS, NRAS, and BRAF tumors without mutation in genes (segments of DNA that contain information for making specific proteins), as shown by local tests. These tests can be done using either tissue samples or blood. 3. Must agree to the submission of fresh tumor tissue. 4. Participants must have cancer that can be measured using RECIST v1.1 guidelines. 5. Participants should have required renal and hepatic function laboratory value. 6. Participants must not have received any prior systemic therapy for unresectable or metastatic CRC.
Exclusion criteria
Exclusion criteria: Participants cannot be included in this study if they meet the following criteria: 1. Have a history of or currently have non-infectious lung diseases such as interstitial lung disease (ILD) (group of disorders that cause progressive scarring of the lung tissue), inflammation of lung tissue (pneumonitis) or scarring of lungs (pulmonary fibrosis). 2. Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and FOLFIRI. 3. Participants have a current or past second cancer other than the one being studied, unless the second cancer is unlikely to affect the studys safety or treatment results. 4. Has active hepatitis of infectious origin at screening. 5 Had radiation therapy within 28 days before starting the study treatment. 6 Has prior exposure to any agents that target EGFR or MET.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Timepoint: Up to 4 years and 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Abnormalities in Laboratory ValuesTimepoint: Up to 7 Years 3 Months;Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) ScoreTimepoint: Up to 7 Years 3 Months;Overall Survival (OS)Timepoint: Up to 7 Years 3 Months;Objective Response Rate (ORR) as Assessed by BICRTimepoint: Up to 7 Years 3 Months;Progression Free Survival (PFS) as Assessed by InvestigatorTimepoint: Up to 7 Years 3 Months;Objective Response Rate (ORR) as Assessed by InvestigatorTimepoint: Up to 7 Years 3 Months;Duration of Response (DOR) as Assessed by BICRTimepoint: Up to 7 Years 3 Months;Duration of Response (DOR) as Assessed InvestigatorTimepoint: Up to 7 Years 3 Months;Progression-free Survival After Subsequent Therapy (PFS2)Timepoint: Up to 7 Years 3 Months;Disease Control Rate (DCR) as Assessed by BICRTimepoint: Up to 7 Years 3 Months;Disease Control Rate (DCR) as Assessed by InvestigatorTimepoint: Up to 7 Years 3 Months;Time to Treatment FailureTimepoint: Up to 7 Years 3 Months;Curative Resection (R0) RateTimepoint: Up to 7 Years 3 Months;Number of Participants with Adverse Events (AEs) by SeverityTimepoint: Up to 7 Years 3 Months | — |
Countries
Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Republic of Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Pvt Ltd.
Outcome results
None listed