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.
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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