A Trial of MK-3475 in Participants With Blood Cancers

Status: Recruiting
Phase:
Diagnosis: Lymphoma
NCT ID: NCT01953692 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-432

 

The purpose of this trial is to evaluate the safety, tolerability, and efficacy of MK-3475 in hematologic malignancies (myelodysplastic syndrome [MDS], smoldering multiple myeloma [SMM], Hodgkin lymphoma [HL], and non-Hodgkin lymphoma [NHL]).

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Philippe Armand, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Have primary or secondary myelodysplastic syndrome (MDS) and have failed to respond to at least 4 cycles of hypomethylating agent, or confirmed diagnosis of smoldering multiple myeloma (SMM) with high-risk for progression, or measurable disease for relapsed/refractory Hodgkin's lymphoma (HL), or measurable disease for relapsed/refractory Non-Hodgkin's lymphoma (NHL) - Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. - Demonstrate adequate organ function - For MDS & SMM: Able to provide bone marrow biopsy/aspirate material for biomarker analysis or is willing to provide a newly obtained bone marrow biopsy/aspirate - For HL & NHL: Able to provide biopsy material for biomarker analysis from their most recent relapse if participant has not received intervening therapy or is willing to provide a newly obtained core or excisional biopsy of a lymph node lesion not previously irradiated Exclusion Criteria: - Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment - Has a diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. - Has received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to agents administered more than 4 weeks earlier - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent - Has undergone prior allogeneic hematopoetic stem cell transplantation - Has a known additional malignancy that is progressing or requires active treatment - Has known clinically active central nervous system (CNS) involvement - Has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents - Has evidence of interstitial lung disease - Has an active infection requiring intravenous systemic therapy - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial - Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (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) - Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection - Has known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Has received a live vaccine within 30 days of planned start of study therapy - For MDS only: is currently receiving treatment with any colony stimulating factors and other hematopoetic cytokines within 2 weeks of enrollment into trial - For SMM only: those with myeloma and history of repeated infections, amyloidosis or hyperviscosity
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