Clinical Trial: Study With Atezolizumab Plus Bevacizumab in Patients With Chemotherapy Resistant, MSI-like, Colorectal Cancer
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase II Open-label Study With the Anti-PD-L1 Atezolizumab Monoclonal Antibody in Combination With Bevacizumab in Patients With Advanced Chemotherapy Resistant Colorectal Cancer and MSI-like Molecul
Brief Summary: The primary objective of this study is to determine the anti-tumor activity, as measured by overall response rate (ORR) of atezolizumab in combination with bevacizumab in patients with chemotherapy resistant CRC and positivity for MSI-like molecular signature. This is an international, open-label single arm (non-randomized), one-stage phase II trial.
Detailed Summary:
Sponsor: Vall d'Hebron Institute of Oncology
Current Primary Outcome: Overall Response Rate [ Time Frame: 36 months from first patient in ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Immune-related tumor response [ Time Frame: 36 months from first patient in ]the measurement that will be used is ir-RECIST (Immune-Related Response Criteria).
- Progression Free Survival [ Time Frame: 36 months from first patient in ]
- Overall Survival [ Time Frame: 36 months from first patient in ]
- Safety and tolerability (adverse event assessment according to CTCAE v 4.0) [ Time Frame: 36 months from first patient in ]
Original Secondary Outcome:
- Immune-related tumor response [ Time Frame: 36 months from first patient in ]
- Progression Free Survival [ Time Frame: 36 months from first patient in ]
- Overall Survival [ Time Frame: 36 months from first patient in ]
- Safety and tolerability (adverse event assessment according to CTCAE v 4.0) [ Time Frame: 36 months from first patient in ]
Information By: Vall d'Hebron Institute of Oncology
Dates:
Date Received: December 1, 2016
Date Started: July 2017
Date Completion: March 2020
Last Updated: May 8, 2017
Last Verified: May 2017
