A phase 1b/2 Study of Ibutinib Combination Therapy in Selected Advanced Gastrointestinal and Genitourinary Tumors.
- Overall Response Rate in Urothelial cohort 5 and 6
- Disease control rate of combination therapy
- Duration of Response
- Overall Survival
- Safety and tolerability
Key Eligibility Criteria
(Not a complete list of inclusion and exclusion criteria, relevant only to Cohort 5 and Cohort 6)
UC Cohort 5:
- Advanced (locally recurrent and/or metastatic) urothellal carcinoma
- 1-2 prior regimens, 1 of which must have included a checkpoint inhibitor
UC Cohort 6:
- Locally advanced or metastatic UC who are not eligible for cisplatin chemo with a PD-L1 score of >= 10
- Locally advanced metastatic UC who have progressed on platinum chemo or within 12 months of neoadjuvant or adjuvant therapy with platinum chemo
UC Cohort 6 only:
- Subjects who have an active, known or suspected autoimmune disease. Subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppresive agents.
- Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
- Non-steroid immunosuppressive medications within 14 days before the first dose of ibrutinib and pembrolizumab.
- Subjects in whom prior anti PD-1 / anti-PD-L1 therapy was intolerable and required discontinuation of treatment.
For additional information on this trial, please visit www.clinicaltrials.gov (NCT02599324)