CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 415 enrolled
Drug / intervention
Quavonlimab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03179436
NCT03179436Phase 2Completed
CompareCT.gov

A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Merck Sharp & Dohme LLC·interventional·Posted Jun 7, 2017·Updated Apr 8, 2025

In Brief

A Phase 2 clinical trial evaluating Quavonlimab, Pembrolizumab, and 1 other intervention for Advanced Solid Tumors. Completed, enrolled 415 participants across 53 sites in 16 countries.

Detailed Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesAustralia, Canada, Chile, China, France, Greece, Israel, Italy, Japan, New Zealand, Poland, South Africa, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 7, 2017
Enrollment StartJul 2, 2017
Primary CompletionApr 8, 2024
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 9.1 years ago

Interventions

Quavonlimabbiological

Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.

Pembrolizumabbiological

Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).

Pembrolizumab/Quavonlimabdrug

Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).