EUCTR2016-000202-11-IT
Active, not recruiting
Phase 1
A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma - A Phase III, open-label, multicenter, three-arm, randomized study to investigate the efficacy and sa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- F. HOFFMANN - LA ROCHE LTD.
- Enrollment
- 363
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Disease specific inclusion criteria:
- •Histologically confirmed adenocarcinoma originating from the colon or
- •rectum (Stage IV American Joint Committee on Cancer 7th edition)
- •Experienced disease progression on at least two prior systemic
- •chemotherapy regimens for mCRC
- •1\. Prior systemic cytotoxic chemotherapy must include ALL of the
- •following agents:
- •a) Fluoropyrimidines
- •b) Irinotecan
- •c) Oxaliplatin
Exclusion Criteria
- •Cancer\-related exclusion criteria:
- •After the approximate 5% cap for MSI\-high patients is reached, only
- •MSI\-stable patients will be eligible.
- •Major surgery or radiotherapy within 21 days prior to Cycle 1 Day 1 or
- •anticipation of needing such procedure while receiving study treatment.
- •Treatment with any anti\-cancer agent within 14 days prior to Cycle 1
- •Uncontrolled tumor\-related pain. Patients requiring narcotic pain
- •medication must be on a stable regimen at study entry.
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring
- •repeated drainage more than once every 28 days. Indwelling drainage
Outcomes
Primary Outcomes
Not specified
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