Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:July 11, 2018
End Date:September 2, 2021
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors

This study will determine the safety and tolerability and to establish a preliminary
recommended Phase 2 dose of MK-4830 administered as monotherapy and in combination with
pembrolizumab (MK-3475) in adults with advance solid tumors.


Inclusion Criteria:

- Has any histologically- or cytologically-confirmed advanced/metastatic solid tumor by
pathology report and have received, have been intolerant to, or have been ineligible
for all treatment known to confer clinical benefit. Solid tumors of any type are
eligible for enrollment.

- Has measurable disease by Response Evaluation Criteria In Solid Tumors version 1.1
(RECIST 1.1) as assessed by the local site investigator/radiology.

- Submits an evaluable baseline tumor sample for analysis (either a recent or archival
tumor sample).

- Has 1 or more discrete malignant lesions that are amenable to biopsy

- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale.

- Demonstrates adequate organ function

- A male participant must agree to use an approved contraception(s) during the treatment
period and for at least 180 days after the last dose of study treatment and refrain
from donating sperm during this period.

- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and either not a woman of childbearing potential (WOCBP) OR if a WOCBP
agrees to follow the study contraceptive guidance during the treatment period and for
at least 120 days after the last dose of study treatment.

Exclusion Criteria:

- Has had chemotherapy, definitive radiation, or biological cancer therapy within 4
weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or
has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE)NCI CTCAE version 4 Grade 1 or better from any AEs that were due
to cancer therapeutics administered more than 4 weeks earlier

- Has not recovered from all radiation-related toxicities to Grade 1 or less, requires
corticosteroids, and had radiation pneumonitis.

- Has a history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.

- Has known untreated central nervous system (ie, brain and/or spinal cord) metastases
or known carcinomatous meningitis.

- Has received any prior immunotherapy and was discontinued from that treatment due to a
Grade 3 or higher residual immune-related AEs

- Previously had a severe hypersensitivity reaction to treatment with a monoclonal
antibody or has a known sensitivity to any component of pembrolizumab.

- Has an active infection requiring therapy.

- Has a history of interstitial lung disease.

- Has a history of (noninfectious) pneumonitis that required steroids or current
pneumonitis.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive
drugs) except vitiligo or resolved childhood asthma/atopy.

- Has clinically significant cardiac disease, including unstable angina, acute
myocardial infarction within 6 months from Day 1 of study drug administration, or New
York Heart Association Class III or IV congestive heart failure.

- Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

- Known active hepatitis B or C.

- Is taking chronic systemic steroids in doses >10 mg daily of prednisone or equivalent
within 7 days prior to the first dose of trial treatment.

- Has not fully recovered from any effects of major surgery without significant
detectable infection. Surgeries that required general anesthesia must be completed at
least 2 weeks before first study treatment administration. Surgery requiring
regional/epidural anesthesia must be completed at least 72 hours before first study
treatment administration and participants should be recovered.

- Has received a live virus vaccine within 30 days of planned treatment start.

- Is currently participating and receiving study therapy in a study of an
investigational agent or has participated and received study therapy in a study of an
investigational agent or has used an investigational device within 28 days of
administration of MK-4830.
We found this trial at
3
sites
San Antonio, Texas 78229
Phone: 210-593-5265
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San Antonio, TX
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Detroit, Michigan 48202
Phone: 313-916-7453
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Detroit, MI
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1967 Riverside Drive
Ottawa, Ontario K1H 7W9
Phone: 613737770070185
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Ottawa,
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