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

F. Hoffman-La Roche Ltd.0 sites363 target enrollmentJuly 18, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The patient population are patients with metastatic or locally advanced unresectable colorectal adenocarcinoma that have received at least two lines of chemotherapy in this setting. The patients must have received 5-FU, oxaliplatin, and irinotecan. Patients who have received an anti-VEGF and anti-EGFR are eligible.
Sponsor: F. Hoffman-La Roche Ltd.
Enrollment: 363
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

July 18, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

F. Hoffman-La Roche Ltd.

•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
•2\. Patients who have received prior anti\-angiogenic therapy (e.g., bevacizumab) and/or anti epidermal growth factor receptor therapy (e.g., cetuximab) are eligible.
•3\. Patients must have had documented disease progression within 3 months of the last systemic therapy administration.
•4\. Patients who were intolerant to prior systemic chemotherapy regimens are eligible if there is documented evidence of clinically significant intolerance despite adequate supportive measures.

•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 Day 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 catheters (e.g., PleurX ) are allowed.
•Active or untreated CNS metastases are excluded. Patients with treated and asymptomatic CNS metastases are eligible,
•Exclusion criteria related to study medication:
•Any cancer immunotherapy including CD137 agonists, anti\-programmed death\-1, anti PD L1, or anti CTLA4; Any MEK or ERK inhibitor; and Regorafenib
•Patients with active malignancy (other than CRC) or a prior malignancy within the past 3 years are excluded. Patients with completely resected cutaneous melanoma (early stage), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in\-situ, breast carcinoma in\-situ, and localized prostate cancer are eligible.