Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)

Part of paid clinical trials in Duarte, California.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03833427
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced/Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1\&2 of each 3-week treatment cycle.
  • Pembrolizumab — DRUG
    Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.

Study Details

This study will examine the safety, pharmacokinetics, and efficacy of escalating doses of selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for participants with advanced / metastatic solid tumors.

Key Dates

Start date
Mar 18, 2019
Status verified
Nov 2024
Primary completion
Jun 28, 2022
Completion
Jun 28, 2022

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Selumetinib at Dose Level 1 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; every three weeks \[Q3W\]) in combination with selumetinib at dose level 1 (dosed orally; twice daily \[BID\]) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 2 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 2 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 3 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 3 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 4 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 4 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 5 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 5 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 6 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 6 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.
  • Experimental: Selumetinib at Dose Level 7 + Pembrolizumab
    Participants receive 200 mg pembrolizumab (IV infusion; Q3W) in combination with selumetinib at dose level 7 (dosed orally; BID) for up to 35 treatment cycles (cycle length: 3 weeks). During each 3-week cycle, selumetinib will be administered only for the first two weeks.

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center ( Site 0004)DuarteCalifornia91010-
START Midwest ( Site 0001)Grand RapidsMichigan49546-
John Theurer Cancer Center ( Site 0002)HackensackNew Jersey07601-
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0003)San AntonioTexas78229-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CASTART Midwest· Grand Rapids, MIJohn Theurer Cancer Center· Hackensack, NJSouth Texas Accelerated Research Therapeutics, LLC (START)· San Antonio, TX

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