Study of MK-4166 and MK-4166 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4166-001)
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|ClinicalTrials.gov Identifier: NCT02132754|
Recruitment Status : Active, not recruiting
First Posted : May 7, 2014
Last Update Posted : September 24, 2018
This is a 5-part dose-escalation study to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of MK-4166 in participants with advanced solid tumors. In Part A, MK-4166 doses will be escalated quickly in successive cohorts and based on safety events may progress to Part B, in which the preliminary MTD will be identified. Based on safety events the study may progress to Part C in which the MTD will be confirmed. In Part D, participants will receive escalating doses of MK-4166 plus a fixed dose of pembrolizumab (MK-3475) 200 mg to determine the MTD for MK-4166 in combination with pembrolizumab. Based on safety events in Part D, the study may progress to Part E in which the MTD for MK-4166 in combination with pembrolizumab will be confirmed.
With Amendments 05/06, the dose confirmation Part E (combination of MK-4166 and pembrolizumab) will be limited to participants with advanced malignant melanoma.
The primary study hypotheses are that MK-4166 as a single agent and MK-4166 in combination with pembrolizumab have acceptable safety and tolerability.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: MK-4166 Biological: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Single Agent MK-4166 and MK-4166 in Combination With Pembrolizumab in Subjects With Advanced Malignancies|
|Actual Study Start Date :||June 27, 2014|
|Estimated Primary Completion Date :||October 17, 2019|
|Estimated Study Completion Date :||October 17, 2019|
Participants receive MK-4166 at assigned dose, intravenously over 30 minutes, on Day 1 of each 21-day cycle, for up to 4 cycles.
Participants receive MK-4166 at assigned dose, intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 4 cycles and receive pembrolizumab 200 mg, intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 24 months.
- Number of participants experiencing dose-limiting toxicities (DLTs) with MK-4166 and with MK-4166+Pembrolizumab [ Time Frame: Cycle 1 (up to 21 days) ]
- Number of participants experiencing adverse events (AEs) [ Time Frame: From first dose up to 30 days post last dose (up to 25 months) ]
- Number of participants discontinuing study drug due to AEs [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132754
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|