for people ages 18 years and up (full criteria)
at UC Irvine UCLA UCSD
study started
estimated completion



The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

Official Title

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


Metastatic Renal Cell Carcinoma Advanced Urothelial Carcinoma Advanced Gastric Adenocarcinoma Metastatic Colorectal Adenocarcinoma Carcinoma Adenocarcinoma Carcinoma, Renal Cell Paclitaxel Docetaxel Pembrolizumab Everolimus Cetuximab Ibrutinib Renal Cell Carcinoma - Enrollment Closed Urothelial Carcinoma - Enrollment Closed Gastric Adenocarcinoma - Enrollment Closed Colorectal Adenocarcinoma - Enrollment Closed Urothelial Carcinoma Ibrutinib- Enrollment Closed


You can join if…

Open to people ages 18 years and up

  • RCC (clear cell), urothelial carcinoma (UC) (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
  • For cohort 1 RCC: minimum of 1 and maximum of 4 prior regimens, one or more of which must have included a VEGF-TKI
  • For UC cohort 2: minimum of 1 and maximum of 2 prior regimens, one of which must have included a platinum-based regimen
  • For UC cohort 5: Minimum of 1 and maximum of 2 prior regimens, one of which must have included a checkpoint inhibitor.
  • For UC cohort 6:
  • Locally advanced or mUC who are not eligible for cisplatin chemo with a PDL-1 score (CPS) of ≥ 10 without prior treatment.
  • Locally advanced or mUC who have progressed on platinum chemo or within 12 months of neo- or adjuvant therapy with a platinum chemotherapy. A minimum of 1 and maximum of 2 prior therapies.
  • For cohort 3 gastric or GEJ adenocarcinoma: minimum of 1 and maximum of 3 prior regimens one of which must have included a fluoropyrimidine regimen
  • For cohort 4 CRC: minimum of 2 and maximum of 4 prior regimens, which must have included both an irinotecan and an oxaliplatin based regimen unless unable to tolerate irinotecan chemotherapy


  • Adequate hematologic function:
  • Absolute neutrophil count ≥1500 cells/mm3 (1.5 x 109/L)
  • Platelet count >80,000 cells/mm3 (80 x 109/L) for cohort 1 (RCC)
  • Platelet counts >100,000 cells/mm3 (100 x 109/L) for all UC cohorts
  • Hemoglobin ≥8.0 g/dL. for cohort 1 (RCC),all UC cohorts, and cohort 3 (GC)
  • Hemoglobin ≥9.0 g/dL for cohort 4 (CRC)
  • Adequate hepatic and renal function defined as:
  • Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤5.0 x upper
  • limit of normal (ULN) if liver metastases, or ≤3 x ULN without liver metastases
  • Alkaline phosphatase <3.0 x ULN or ≤5.0 x ULN if liver or bone metastases present
  • Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic
  • origin, such as hemolysis) with the exception of subjects in the GC cohort where
  • docetaxel is administered, these subjects must have bilirubin within normal limits (WNL)
  • Estimated Creatinine Clearance ≥30 mL/min (Cockcroft-Gault)

You CAN'T join if...

  • Prior treatment with:
  • Everolimus or temsirolimus (RCC cohort 1)
  • Any taxane (UC cohort of ibrutinib + paclitaxel) (cohort 2)
  • Checkpoint inhibitors (UC cohort 6)
  • Any taxane (GC cohort 3)
  • Cetuximab or panitumumab (CRC cohort 4)
  • For all Cohorts:
  • Concomitant use of warfarin or other Vitamin K antagonists
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • Major surgery within 4 weeks of first dose of study drug
  • Requires treatment with strong CYP3A inhibitors known bleeding disorders or hemophilia
  • UC cohort 6 only:
  • Subjects who have an active, known or suspected autoimmune disease.
  • 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.


  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • University of California Irvine
    Orange California 92868 United States
  • UCLA
    Santa Monica California 90404 United States
  • St. Mary's Medical Center
    San Francisco California 94117 United States


in progress, not accepting new patients
Start Date
Completion Date
Pharmacyclics LLC.
Phase 1/2
Study Type
Last Updated