A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Colorectal Cancer (Morpheus-CRC)
- Conditions
- Colorectal cancer (CRC)MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004566-99-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
-Age >=18 years
-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-Life expectancy >= 3 months, as determined by the investigator
-Disease progression during or following two separate lines of treatment for mCRC that consisted of fluoropyrimidine-, oxaliplatin-, or irinotecan-containing chemotherapy in combination with a biologic agent
-Availability of a representative tumor specimen that is suitable for determination of Programmed cell Death-1 (PD-L1) and/or additional biomarker status by means of central testing
-Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
-Adequate hematologic and end-organ function
-For patients receiving therapeutic anticoagulation: stable anticoagulant regimen during the 14 days prior to initiation of study treatment
-Negative HIV test and hepatitis B surface antigen test at screening
-Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Tumor accessible for biopsy
- For women and men: agreement to remain abstinent or use contraceptive measures as outlined for each specific treatment arm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48
-High microsatellite instability tumor
-Mutation in the BRAF oncogene
-Prior treatment with any of the protocol-specified study treatments with the exception of patients who received bevacizumab for treatment of CRC.
-Prior allogeneic stem cell or solid organ transplantation
-Symptomatic, untreated, or actively progressing central nervous system metastases
-History of leptomeningeal disease
-Active or history of autoimmune disease or immune deficiency, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
-History of malignancy other than CRC within 2 years prior to screening
-Active tuberculosis
-Severe infection within 4 weeks prior to initiation of study treatment
-Significant cardiovascular disease
-Grade >= 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
-Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
-Adverse events from prior anti-cancer therapy that have not improved to Grade <= 1 or better, with the exception of alopecia of any grade and Grade <= 2 peripheral neuropathy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method