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0S-15-1: A Multi-Center Study of the Brutons Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with MEDI4736, in Subjects with Relapsed or Refractory Solid Tumors

Description

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.

Phase

Phase 1/2 - for trials that are a combination of phases 1 and 2.

Inclusion and Exclusion Criteria

  • Pathologically confirmed Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma)
  • Relapsed or refractory disease (Stage III or IV): NSCLC must have failed at least 1 prior treatment.
  • Measurable lesion by RECIST 1.1
  • Adequate hematologic function: - ANC >1500 cells/mm3 - Platelet count >100,000 cells/mm3 - HGB >9.0 g/dL
  • 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
  • PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN

  • Mixed small cell and NSCLC histology
  • 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.
  • Anti-tumor therapy within 21 days of study Day 1
  • 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.
  • History of allogeneic organ transplant
  • Treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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