Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced/Metastatic Solid Tumors | Drug: Selumetinib Biological: Pembrolizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Multi-center Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors. |
Actual Study Start Date : | March 18, 2019 |
Estimated Primary Completion Date : | August 30, 2022 |
Estimated Study Completion Date : | August 30, 2022 |
Arm | Intervention/treatment |
---|---|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
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.
|
Drug: Selumetinib
Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
Other Name: MK-5618
Biological: Pembrolizumab Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
Other Names:
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
City of Hope National Medical Center ( Site 0004) | |
Duarte, California, United States, 91010 | |
United States, Michigan | |
START Midwest ( Site 0001) | |
Grand Rapids, Michigan, United States, 49546 | |
United States, New Jersey | |
John Theurer Cancer Center ( Site 0002) | |
Hackensack, New Jersey, United States, 07601 | |
United States, Texas | |
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0003) | |
San Antonio, Texas, United States, 78229 | |
Canada, Ontario | |
Princess Margaret Cancer Centre ( Site 0014) | |
Toronto, Ontario, Canada, M5G 1Z5 | |
Canada | |
CHU de Quebec Universite de Laval ( Site 0013) | |
Quebec, Canada, G1R 2J6 |
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Tracking Information | |||||||
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First Submitted Date ICMJE | February 6, 2019 | ||||||
First Posted Date ICMJE | February 7, 2019 | ||||||
Last Update Posted Date | December 17, 2020 | ||||||
Actual Study Start Date ICMJE | March 18, 2019 | ||||||
Estimated Primary Completion Date | August 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001) | ||||||
Official Title ICMJE | A Phase 1b Multi-center Clinical Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors. | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced/Metastatic Solid Tumors | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
50 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 30, 2022 | ||||||
Estimated Primary Completion Date | August 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03833427 | ||||||
Other Study ID Numbers ICMJE | 5618-001 MK-5618-001 ( Other Identifier: Merck Protocol Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |