Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

Summary

Participation Requirements

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 purpo...

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 quavonlimab 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 an Efficacy Expansion Cohort. During the Efficacy Expansion Phase, participants will be randomized to receive either quavonlimab in combination with pembrolizumab or quavonlimab monotherapy. Protocol Amendment 7 will enroll participants in a new cohort (Arm I). During the Coformulation Phase, the safety and PK of a coformulated product of pembrolizumab/quavonlimab (MK-1308A) will be evaluated in comparison to that of the single, co-administered products given at the same dose and schedule. Protocol Amendment 8 will enroll participants in 3 new cohorts (Arms J, K, and L). Arm J enrolls participants with refractory melanoma and Arm K enrolls participants in mainland China with relapsed or refractory solid tumor. Arms J and K will receive pembrolizumab/quavonlimab. Arm L enrolls participants in Japan with first-line advanced NSCLC. Participants in Arm L will be divided into 4 sub-cohorts and these sub-cohorts will receive 4 cycles of an indicated chemotherapy PLUS pembrolizumab/quavonlimab.

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