Clinical Trial 17986

Cancer Type: Multiple
Interventions:CP-675,206 (tremelimumab); KW-0761 (Mogamulizumab); MEDI4736 (Durvalumab); Mogamulizumab; Not Applicable; tremelimumab

Study Type: Treatment
Phase of Study: Phase I
Investigators:


    Overview

    Study Title

    Phase 1 Study of Mogamulizumab (KW-0761) in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors

    Summary

    The purpose of this study is to test the safety, tolerable adverse events (side effects) and determine the highest tolerable dose of a combination of three investigational study drugs, Mogamulizumab and MEDI4736 or Mogamulizumab and tremelimumab, in participants who have locally advanced or metastatic solid tumors.

    Objective

    To characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose in the absence of exceeding the MTD of the combinations of mogamulizumab+MEDI4736 and mogamulizumab+tremelimumab in subjects with locally advanced or metastatic disease.

    Inclusion Criteria

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  • Age ≥ 18 years
  • Locally advanced or metastatic solid tumors
  • Histologically or cytologically confirmed disease
  • Failed or were intolerant to at least one prior systemic treatment regimen with oral or IV medications and have no additional therapy options known to prolong survival. Potential participants with non-small cell lung cancer must have received at least one platinum doublet regimen. Potential participants with known epidermal growth factor receptor tyrosine kinase inhibitor activating mutations or anaplastic lymphoma kinase rearrangement must have also exhausted approved targeted therapy options.

  • Exclusion Criteria

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  • Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior
  • Concurrent or prior use of immunosuppressive medication within 28 days
  • Active or prior documented autoimmune or inflammatory bowel disease within 3 years with some exceptions
  • Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy