Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Amivantamab: 1600 or 2240 mg/vial with
concentration of 160 mg/mL
1600 mg (BW less than 80 kg) or
2240 mg (BW more than and equal to 80 kg)
Route of administration: SC
Cycle 1: weekly
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 colorectal cancer through lab tests or tissue samples. 2. Have been diagnosed with KRAS, NRAS, and BRAF wild-type tumor 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 have a cancer which has returned following an initial round of chemotherapy with or without other targeted agents. 4. Must agree to the submission of fresh tumor tissue after disease progressed from last therapy. 5. Participants must have cancer that can be measured using response evaluation criteria in solid tumors (RECIST) v 1.1 guidelines.
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 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, cetuximab or bevacizumab (b) any component of 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. Participants have been treated with irinotecan or any agents that target EGFR or MET. 5. Has active hepatitis of infectious origin at screening. 6. Had radiation therapy within 28 days before starting the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Timepoint: Up to 2 years 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: Up to 4 years 4 months;Objective Response Rate (ORR) as Assessed by BICRTimepoint: Up to 4 years 4 months;Progression Free Survival as Assessed by InvestigatorTimepoint: Up to 4 years 4 months;Objective Response Rate as Assessed by InvestigatorTimepoint: Up to 4 years 4 months;Duration of Response (DoR) as Assessed by BICRTimepoint: Up to 4 years 4 months;Duration of Response as Assessed by InvestigatorTimepoint: Up to 4 years 4 months;Progression Free Survival After Subsequent Therapy (PFS2)Timepoint: Up to 4 years 4 months;Disease Control Rate (DCR) as Assessed by BICRTimepoint: Up to 4 years 4 months;Disease Control Rate as Assessed by InvestigatorTimepoint: Up to 4 years 4 months;Time to Treatment FailureTimepoint: Up to 4 years 4 months;Curative Resection (R0) RateTimepoint: Up to 4 years 4 months;Number of Participants with Adverse Events (AEs) by SeverityTimepoint: Up to 4 years 4 months;Number of Participants with Abnormalities in Laboratory ValuesTimepoint: Up to 4 years 4 months;Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) ScoreTimepoint: Up to 4 years 4 months;Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C29) ScoreTimepoint: Up to 4 years 4 months;Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C29 ScoreTimepoint: Up to 4 years 4 months;Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale ScoreTimepoint: Up to 4 years 4 months | — |
Countries
Australia, Belgium, Brazil, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Republic of Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Pvt Ltd
Outcome results
None listed