Status:
TERMINATED
1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Ashraf Badros
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed 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 outpa...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003)
- Received two 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). (a). Prior pomalidomide therapy is permitted, provided the patient achieved at least a partial remission and had not progressed for 3 months after stopping therapy.
- Measureable disease as defined by the protocol (assessed within 28 days prior to registration).
- Be willing and able to provide written informed consent/assent for the trial.
- Be over 18 years of age on day of signing informed consent.
- Have a performance status of 2 on the ECOG Performance Scale.
- Demonstrate adequate organ function as defined by the protocol.
- Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
- Male subjects should agree to use an adequate method of contraception.
Exclusion
- 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 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.
- 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.
- 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.)
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or situ cervical cancer that has undergone potentially curative therapy.
- Has known active central nervous system disease and/or carcinomatous meningitis.
- 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.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- 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.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or breastfeeding, or expecting to conceive or father children during study participation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as per the protocol.
- has known active Hepatitis B or Hepatitis C.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
Key Trial Info
Start Date :
December 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02289222
Start Date
December 30 2014
End Date
August 7 2017
Last Update
November 5 2019
Active Locations (1)
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1
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1592