Last updated on August 2019

Safety Pharmacokinetics (PK) and Efficacy of MK-1308 in Combination With Pembrolizumab in Advanced Solid Tumors (MK-1308-001)

Brief description of study

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of MK-1308 when used in combination with pembrolizumab in participants with advanced solid tumors.

Detailed Study Description

After screening, participants are assigned to either the Dose Escalation Phase or Dose Confirmation Phase. The Dose Escalation Phase consists of 3 cohorts and will evaluate available PK and safety data from the first 6 participants of each cohort, including dose limiting toxicities (DLTs). The purpose of the Dose Confirmation Phase is to gather additional safety, tolerability, PK, and preliminary efficacy data of MK-1308 in combination with pembrolizumab. The 5 arms of the Dose Confirmation Phase will include advanced/metastatic non-small cell lung cancer (NSCLC) and second line advanced/metastatic small cell lung cancer (SCLC). In participants who have initial evidence of radiological progressive disease (PD) by modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, it will be at the discretion of the investigator whether to continue a participant on study treatment until repeat imaging is obtained.

Protocol Amendment 4 will enroll participants with melanoma in a limited Efficacy Expansion Cohort. During the Efficacy Expansion Phase, participants will be randomized to receive either MK-1308 in combination with pembrolizumab or MK-1308 monotherapy.

Clinical Study Identifier: NCT03179436

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