Study of Preladenant (MK-3814) Alone and With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3814A-062)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03099161
• Date of registration: 30/03/2017
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Study of Preladenant (MK-3814) Alone and With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3814A-062)
• Scientific title: A Phase Ib/II Study to Evaluate the Safety and Tolerability of Preladenant as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Malignancies
• Date of first enrolment: June 27, 2017
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03099161
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Canada, Israel, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has a histologically- or pathologically-documented, locally-advanced or metastatic
solid tumor for which standard therapy, either does not exist or has been proven
ineffective, intolerable or refused by the participant. Each participant must have
received at least one and up to five prior lines of cancer treatment regimens,
excluding neo-adjuvant, adjuvant, maintenance treatment and surgery

- Has provided a tumor tissue sample (archival or newly obtained core or excisional
biopsy of a tumor lesion)

- Has measurable disease per RECIST 1.1

- Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Females must not be pregnant

- Female and male participants of reproductive potential must agree to use adequate
contraception starting from the first dose of study therapy, throughout the study
period, and for up to 120 days after the last dose of study therapy

Exclusion Criteria:

- Has disease that is suitable for local treatment administered with curative intent

- Has received previous treatment with an immunomodulatory agent (e.g, anti- Programmed
Cell Death Receptor 1/ Programmed Cell Death Receptor Ligand 1 or anti-cytotoxic
T-lymphocyte-associated antigen-4) and was discontinued from treatment due to a Grade
3 or higher immune-related adverse event

- Has received previous treatment with an adenosine A2a receptor antagonist (e.g.
CPI-444, HTL1071, PBF-509)

- Has had chemotherapy, definitive radiation, or biological cancer therapy within 4
weeks of the first dose of study therapy, or has not recovered to Common Toxicity
Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse event

- Is currently participating or has participated in a study with an investigational
agent or using an investigational device within 28 days of the first dose of study
therapy

- Is currently taking or has taken drugs that interfere with Cytochrome P450 (CYP)3A4 or
CYP2C8 or grapefruit and star fruit in diet within 14 days of the first dose of study
therapy

- Is currently taking or has taken proton pump inhibitors within 5 days of the first
dose of study therapy

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days of the first dose of
study therapy

- Is expected to require any other form of systemic or localized antineoplastic therapy
while on study

- Has a history of a second malignancy, unless potentially curative treatment has been
completed, with no evidence of malignancy for 5 years

- Has clinically active central nervous system metastases and/or carcinomatous
meningitis

- History of a severe hypersensitivity reaction to treatment with the monoclonal
antibody/components of the study drug

- Has an active infection requiring therapy

- History of interstitial lung disease

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- History of active tuberculosis

- Has an active autoimmune disease that has required systemic treatment in the past 2
years

- Has received a live-virus vaccine within 30 days of the first dose of study therapy

- Has known Human Immunodeficiency Virus (HIV) (HIV 1 or 2 antibodies) and/or known
active and acute Hepatitis B or C infections

- Has known psychiatric or substance abuse disorders that would interfere with the
ability to cooperate with the requirements of the study

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study

- Has not fully recovered from any effects of major surgery without significant
detectable infection

- Has had surgery that required general anesthesia within 2 weeks of the first dose of
study therapy

- Has had surgery that required regional/epidural anesthesia within 72 hours of the
first dose of study therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasm

Intervention(s)

Drug: preladenant

Biological: pembrolizumab

Primary Outcome(s)

Number of Participants With Dose-limiting Toxicities (DLTs) [Time Frame: Cycle 1 (up to 21 days)]

Number of Participants Who Experienced at Least One Adverse Event (AE) [Time Frame: Up tp approximately 8 months]

Number of Participants Who Discontinued Study Treatment Due to an AE [Time Frame: Up to approximately 8 months]

Secondary Outcome(s)

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time Frame: Up to approximately 8 months]

Secondary ID(s)

3814A-062

MK-3814A-062

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03099161