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Protocol No. UW16004

Principal Investigator Chang, Julie

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase Ib Trial of Pembrolizumab in Combination with Dinaciclib in Subject with hematologic Malignancies

Objective The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drugs, pembrolizumab (also known as MK-3475) in combination with dinaciclib (also known as MK-7965) in subjects with hematologic malignancies.

Treatment Pembrolizumab, also known as KEYTRUDA®, is available by prescription for certain types of melanoma, head and neck and non-small cell lung cancer; however, it has not been approved in any other cancers and its use in this study is considered experimental. The second drug, dinaciclib, is an experimental drug. "Experimental" means that it has not been approved by the Food and Drug Administration (FDA) for sale in the United States but it is being developed for the treatment of human malignancies.

Description In Cycle 1, pembrolizumab will be administered intravenously on day 1; dinaciclib will be administered intravenously on day 1, and on day 8. Each cycle is 21 days. In Cycle 2 and beyond, pembrolizumab will be administered on day 1 and dinaciclib will be administered on day 1 and day 8.

Key Eligibility
  • Confirmed diagnosis of CLL, active MM or DLBCL
  • If confirmed CLL, must have received at least one prior therapy
  • If confirmed diagnosis of active MM, must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment defined as documented
  • disease progression during or within 60 days of completing their last anti-myeloma therapy. Prior anti-myeloma treatments must have included an IMiD (pomalidomide,lenalidomide, or thalidomide) AND proteasome inhibitor (bortezomib, carfilzomib, orixazomib) alone or in combination
  • If confirmed DLBCL, subjects must have progressed following at least 2 lines of previous therapy, including progression after an autologous stem cell transplant (CST), or are not a candidate (per institutional criteria) for an autologous stem cell transplant
  • If patient has known clinically active central nervous system (CNS) involvement they are ineligible
  • If patient has a known history of immunosuppression or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment, they are excluded
  • I
  • f patient has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years they are ineligible. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease
  • If patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment they are ineligible
  • If patient with CLL has Richter's Transformation, they are ineligible
  • If MM patients have non-secretory or oligo-secretory myeloma, plasma cell leukemia or Waldenström's macroglobulinemia they are ineligible
  • If MM patients have a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) they are ineligible
  • If DLBCL subjects have primary mediastinal B-cell lymphoma (PMBCL) or Richter's Transformation they are excluded

Applicable Disease Sites Leukemia; Lymphoma; Multiple Myeloma

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved Dinaciclib; Keytruda (pembrolizumab); MK-3475 (pembrolizumab); pembrolizumab

Status Open

Participating Institutions UW Hospital and Clinics