Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase Ib, Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Patients With Previously Treated Metastatic, Microsatellite-Stable Colorectal Adenocarcinoma With High CEACAM5 Expression
Study ID: NCT03866239
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars Sinai Medical Center, Los Angeles, California, United States
UCLA Cancer Center, Santa Monica, California, United States
Stanford Comprehensive Cancer Center, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
Rigshospitalet; Fase 1 Enhed - Onkologi, København Ø, , Denmark
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut Gustave Roussy, Villejuif, , France
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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