1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma

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.

Inclusion Criteria:

1. Confirmed diagnosis of relapsed and/or refractory MM according to International
Myeloma Working Group guidelines (2003)

2. 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.

3. Measureable disease as defined by the protocol (assessed within 28 days prior to
registration).

4. Be willing and able to provide written informed consent/assent for the trial.

5. Be over 18 years of age on day of signing informed consent.

6. Have a performance status of 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.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or situ cervical cancer that has undergone potentially curative therapy.

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.

11. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

12. Pregnant or breastfeeding, or expecting to conceive or father children during study
participation.

13. 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.

14. has known active Hepatitis B or Hepatitis C.

15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

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