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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in subjects 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

Keywords

Non-Small Cell Lung Cancer Pharmacyclics PCYC Ibrutinib Durvalumab (MEDI4736) Relapsed Refractory Solid Tumor NSCLC Squamous Squamous NSCLC Squamous Non-Small Cell Lung Cancer Immunotherapy IMBRUVICA® Tumor Immunotherapy Anti-PD-L1 Lung Cancer Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Pathologically confirmed Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma)
  2. Relapsed or refractory disease (Stage III or IV): NSCLC must have failed at least 1 prior treatment.
  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 or Creatinine Clearance ≥40 mL/min
  6. PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN

You CAN'T join if...

  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.

  1. History of allogeneic organ transplant
  2. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Locations

  • San Francisco, California, USA
  • La Jolla, California, USA
  • Los Angeles, California, 90025, USA
  • Los Angeles, California, 90048, USA
  • Palo Alto, California, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02403271
Phase
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
January 2017