Pembrolizumab, Pomalidomide, and Dexamethasone in Treating Patients with Relapsed or Refractory Multiple Myeloma
This trial is active, not recruiting.
|Treatments||mk-3475, pomalidomide, dexamethasone|
|Phase||phase 1/phase 2|
|Collaborator||Merck Sharp & Dohme Corp.|
|Start date||December 2014|
|End date||December 2016|
|Trial size||48 participants|
|Trial identifier||NCT02289222, GCC1454|
This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The number of Participants with Adverse Events
time frame: The number of participants will adverse events will be assessed beginning after 8 weeks of study therapy of MK-3475, and will occur every 4 weeks thereafter for up to 24 months.
The Identification of biomarker PD-LI & Correlate Positive Expression
time frame: Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)
Time to Progression Free Survival (PFS)
time frame: PFS assessments will take place after starting study thearpy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003) 2. Documented disease progression during or within 60 days after their most recent line of anti-myeloma therapy. 3. Failure of 2 lines of prior therapy that includes an IMiD (lenalidomide or thalidomide) and a Proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination). 4. Measurable disease as defined by the protocol. 5. Be willing and able to provide written informed consent/assent for the trial. 6. Have a performance status of 0 1 2 on the ECOG Performance Scale. 7. Demonstrate adequate organ function as defined by the protocol. 8. Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug. 9. Male subjects should agree to use an adequate method of contraception. Exclusion Criteria: 1. 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. 2. Has a diagnosis of immunodeficiency (HIV) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.) 5. Has a known additional malignancy that is progressing or requires active treatment. 6. Has known active central nervous system disease and/or carcinomatous meningitis. 7. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. 8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 9. Has an active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
|Official title||Phase I/II Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma|
|Principal investigator||Ashraf Z Badros, M.B.,Ch.B|
|Description||This phase I/II study is focused on patients with relapsed or refractory multiple myeloma. MK-3475 will be given as an intravenous infusion at every 2 weeks. Treatment will be administered on an outpatient basis.|
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