Protocol: PCYC-1128-CA

Disease: Metastatic Renal Cell Carcinoma (RCC); Advanced Urothelial Carcinoma (UC); Advanced Gastric Adenocarcinoma (GA); Metastatic Colorectal Adenocarcinoma (CRC)

A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

Study Schema (N = up to 348)

  • Currently enrolling subjects with Advanced Urothelial Carcinoma only (Cohorts 5 & 6)
Recruiting   CheckMark
Protocol PCYC-1128-CA

A phase 1b/2 Study of Ibutinib Combination Therapy in Selected Advanced Gastrointestinal and Genitourinary Tumors.


Study Schema


BTKTrials 1128-CA Image

Primary Objective


  • Overall Response Rate in Urothelial cohort 5 and 6

Secondary Objectives

  • PFS
  • 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)

Inclusion Criteria:
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

Exclusion Criteria:
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 (NCT02599324)


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The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.