A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT03866239
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
CO40939 is a Phase Ib, open-label, multicenter, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of cibisatamab in combination with atezolizumab administered after pretreatment with obinutuzumab in patients with Stage IV microsatellite stable (MSS) metastatic colorectal cancer (mCRC) whose tumors have high carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expression and who have progressed on two or more chemotherapy regimens. The study is composed of a safety run-in and an exploratory part.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab Obinutuzumab Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days). Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab Cibisatamab Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days). Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab Tocilizumab Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days). Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab Atezolizumab Participants will receive obinutuzumab approximately 2 weeks before receiving atezolizumab and cibisatamab on Day 1 of each treatment cycle (cycle = 21 days).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) Up to 5 years Confirmed Objective Response Rate (ORR) Baseline up to 5 years
- Secondary Outcome Measures
Name Time Method Confirmed ORR, as Determined by an Independent Review Facility (IRF) According to Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) Up to 5 years Duration of Response (DOR) From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) Disease Control Rate (DCR) Up to 5 years Progression Free Survival (PFS) From enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 5 years) Overall Survival (OS) From enrollment to death from any cause (up to 5 years) Total Clearance (CL) for Cibisatamab At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years) Volume of Distribution at Steady State (Vss) of Cibisatamab At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years) Area Under the Concentration-Time Curve (AUC0-t) for Cibisatamab At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years) Maximum Serum Concentration (Cmax) of Cibisatamab At pre-defined intervals from Day 1 to progressive disease and/or treatment discontinuation (up to 5 years) CL of Atezolizumab At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days) Vss of Atezolizumab At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days) AUC0-t of Atezolizumab At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days) Cmax of Atezolizumab At pre-defined intervals from Day 1, Cycle 1 through Cycle 8 (cycle = 21 days) CL of Obinutuzumab At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days) Vss of Obinutuzumab At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days) AUC0-t of Obinutuzumab At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days) Cmax of Obinutuzumab At pre-defined intervals from the start of obinutuzumab pretreatment through Cycle 8 (cycle = 21 days) Incidence of Anti-Drug Antibodies (ADAs) to Cibisatamab Baseline up to 5 years Incidence of ADAs to Atezolizumab Baseline up to 5 years Incidence of ADAs to Obinutuzumab Baseline up to 5 years
Trial Locations
- Locations (13)
Centre Leon Berard; Departement Oncologie Medicale
🇫🇷Lyon, France
Stanford Comprehensive Cancer Center
🇺🇸Stanford, California, United States
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
UCLA Cancer Center
🇺🇸Santa Monica, California, United States
Hospital Univ Vall d'Hebron; Servicio de Oncologia
🇪🇸Sant Andreu de La Barca, Barcelona, Spain
Yale University
🇺🇸New Haven, Connecticut, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Rigshospitalet; Fase 1 Enhed - Onkologi
🇩🇰København Ø, Denmark
Institut Gustave Roussy
🇫🇷Villejuif, France
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Clinica Universitaria de Navarra; Servicio de Oncologia
🇪🇸Pamplona, Navarra, Spain
Duke Cancer Center
🇺🇸Durham, North Carolina, United States