A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors

Not Recruiting

Trial ID: NCT02403271


This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.

Official Title

A Multi-Center Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Durvalumab (MEDI4736), in Subjects With Relapsed or Refractory Solid Tumors

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Melinda L. Telli, M.D.
Melinda L. Telli, M.D.

Professor of Medicine (Oncology)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


Inclusion Criteria:

   1. Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or
   squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic
   Cancer (adenocarcinoma)

   2. Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have
   failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior

   3. Measurable lesion by RECIST 1.1

   4. Adequate hematologic function:

      - ANC >1500 cells/mm3

      - Platelet count >100,000 cells/mm3

      - HGB >9.0 g/dL

   5. Adequate hepatic and renal function:

      - AST and ALT ≤2.5 x ULN for subjects without liver metastases and ≤3.5 x ULN for
      subjects with liver metastases

      - Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
      non-hepatic origin)

      - Creatinine ≤2.0 x ULN and Creatinine Clearance ≥40 mL/min (Cockcroft-Gault or
      24-hour creatinine clearance collection)

   6. PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN

Exclusion Criteria:

   1. Mixed small cell and NSCLC histology

   2. A history of CNS involvement except as follows: Subjects with previously treated CNS
   metastases that are adequately treated with whole brain radiotherapy, that are
   neurologically stable, and do not require corticosteroids for symptomatic management
   for at least 14 days prior to first dose of study drug. There must be no clear
   evidence of radiographically active disease for at least 90 days prior to enrollment.

   3. Anti-tumor therapy within 21 days of study Day 1

   4. Prior treatment with ibrutinib or other BTK inhibitor anti-CD137 or CTLA-4 antibody.
   The following are exceptions to this criterion: Subjects previously treated with an
   anti-PD1, anti-PD-L1, or anti-PD-L2 antibody.

   5. History of allogeneic organ transplant

   6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor


drug: Ibrutinib

drug: Durvalumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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