Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155)



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/3/2019
Start Date:March 29, 2016
End Date:February 6, 2020
Contact:Toll Free Number
Phone:1-888-577-8839

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155).

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.

During an initial Dose Evaluation phase (first 2 cycles) to determine Dose Limiting
Toxicities (DLTs), dose combinations of pembrolizumab 200 mg followed by dinaciclib 7 mg/m^2,
pembrolizumab 200 mg followed by dinaciclib 10 mg/m^2, and pembrolizumab 200 mg followed by
dinaciclib 14 mg/m^2 will be evaluated. Following safety review of the Dose Evaluation Phase,
approximately 30 participants each will be enrolled in rrCLL, rrMM, or DLBCL cohorts during
the Signal Detection phase. For each disease type objective response rate (ORR) will be
determined by disease specific criteria.

The rrMM cohort was closed to enrollment on 07-AUG-2017 due to lack of efficacy.


Inclusion Criteria:

- Females must not be pregnant (negative urine or serum human chorionic gonadotropin
test within 72 hours of study start)

- Female and male participants of reproductive potential must agree to use adequate
contraception starting from the first dose of study medication, throughout the study
period, and for up to 120 days after the last dose of study medication

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Cardiac function suitable for protocol-required hydration as determined by the
investigator and/or cardiologist

- Must be able to provide biopsy specimens obtained ≤3 months for biomarker analysis. If
bone marrow biopsy was performed 3 months before screening but subject had anti-cancer
treatment after biopsy, the bone marrow biopsy and aspiration should be repeated

CLL Participants:

- Must have a confirmed diagnosis of CLL defined by 2008 International Workshop on
Chronic Lymphocytic Leukemia (iwCLL) criteria

- Must have received one prior therapy for CLL

- Must meet one or more of the consensus criteria for initiating treatment

MM Participants:

- Must have a confirmed diagnosis of active MM

- Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy
and failed last line of treatment (disease progression ≤60 days of completion of last
therapy)

- Must have failed prior anti-myeloma treatments that have included an immunomodulatory
drug (IMiD) (pomalidomide, lenalidomide, or thalidomide) AND proteasome inhibitor
(bortezomib, carfilzomib, or ixazomib) alone or in combination

DLBCL Participants:

- Must have a confirmed diagnosis of DLBCL and have progressed following ≥2 lines of
previous therapy, after autologous stem cell transplant, or not a candidate for
autologous stem cell transplant

- Must have measurable disease (≥1 lesion that is >15 mm in the longest diameter or by
>10 mm in the short axis)

Exclusion Criteria:

- Has been treated with a cytochrome P450 3A4 (CYP3A4) strong inhibitor or inducer
within 7 days of enrollment

- Has been treated with anti-cancer therapy or thoracic radiation therapy within 14 days

- Has known clinically active central nervous system (CNS) involvement

- Has a known history of immunosuppression or is receiving systemic steroid therapy or
any other form of systemic immunosuppressive therapy within 7 days

- Has had prior anti-cancer monoclonal antibody within 4 weeks of Study Day 1 or who has
not recovered from adverse events due to agents administered >4 weeks earlier

- Has undergone prior allogeneic hematopoetic stem cell transplantation within the last
5 years

- Has a known additional malignancy that is progressing or requires active treatment

- Has active autoimmune disease that has required systemic treatment in past 2 years

- Has received prior therapy with an anti-programmed cell death-1 (PD-1),
anti-programmed cell death ligand (PD-L) 1, anti-PD-L2, anti-CD137, or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
or chimeric antigen receptor (CAR)-T cell therapy or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor

- Has been previously treated with a cyclin-dependent kinase (CDK) inhibitor

- Has a known history of Human Immunodeficiency Virus (HIV) infection

- Has a known history of or is positive for hepatitis B (hepatitis B surface antigen
reactive) or hepatitis C (hepatitis C virus RNA [qualitative] is detected)

- Has received a live vaccine within 30 days prior to the first dose of trial treatment

- Participants with non-secretory or oligo-secretory myeloma, plasma cell leukemia or
Waldenström's macroglobulinemia

- History of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell
dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)

- Participants with primary mediastinal B-cell lymphoma (PMBCL)

- Participants with CLL or DLBCL who have Richter's Transformation

- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis

- Has known current symptomatic congestive heart failure, unstable angina pectoris, or
cardiac arrhythmia
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New Brunswick, New Jersey 08901
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North Ryde, 2113
Phone: 61 2 8988 8428
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