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Keynote-155


Title Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies
Therapeutic Area Hematologic Malignancies, Chronic Lymphocytic Leukemia, Lymphomas (adult), Mantle Cell Lymphoma
Principal Investigator Andreas Klein, MD
Min Age 18 Years
Gender Both
Contact Liz Kendricken, RN
617-636-5558
More Information https://clinicaltrials.gov/ct2/show/NCT02684617

Overview

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

Study Details

Inclusion Criteria

  • Must be willing to use contraception
  • Must be relasped CLL, MM, or DLBCL
  • Must have adequate organ function

Exclusion Criteria

  • Must not have undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years
  • Must not have had anti-cancer theraphy or radiation therphy within 14 days
  • Must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Study Requirements

Study subjects will have a screening visit within 28 days of starting treatment. This visit includes a x-ray, MRI, CT, PET/CT, bone marrow and/or lymph node biopsies to assess disease status and response if not done in the previous 3 months. In addition to clinically indicated labs subjects will be asked to give an additional blood sample: approximately 2.5 tablespoons for Cycle 1, 1.5 tablespoons for Cycle 2, and 1 tablespoon for Cycle 3. Subjects can remain on trial for up to 35 cycles (approximately 2 years), or unacceptable toxicities, or disease progression occurs.