Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001)
Status:
Recruiting
Trial end date:
2025-01-24
Target enrollment:
Participant gender:
Summary
This is a safety, efficacy, and pharmacokinetics (PK) study of vibostolimab (MK-7684) as
monotherapy and in combination with pembrolizumab (MK-3475) or pembrolizumab plus pemetrexed
and carboplatin in adults with metastatic solid tumors for which there is no available
therapy that is expected to convey clinical benefit. Part A of this study is a dose
escalation and confirmation phase to estimate the recommended Phase 2 dose (RPTD) for
vibostolimab monotherapy or in combination with pembrolizumab, pemetrexed, and carboplatin.
Part A will also evaluate the anti-tumor activity of vibostolimab in combination with
pembrolizumab plus pemetrexed and carboplatin in participants with non-small cell lung cancer
(NSCLC) and vibostolimab (at two dose levels) in combination with pembrolizumab in Japanese
participants with gastric cancer. Part B will evaluate the anti-tumor activity of
vibostolimab at the RPTD when used as monotherapy and in combination with pembrolizumab in
participants with advanced solid tumors in a non-randomized study design. Part B will also
evaluate 2 doses of vibostolimab in combination with pembrolizumab in participants with
programmed death 1 (PD-1) treatment naïve cancer using a 1:1 randomized study design. Part B
is expanded with Amendment 11 to include an additional arm that will compare the safety and
PK of a fixed dose of pembrolizumab/vibostolimab coformulation (MK-7684A) to vibostolimab in
combination with pembrolizumab administered as separate intravenous infusions. Part A is
expanded with Amendment 12 to include an additional arm that will compare the safety and PK
of vibostolimab plus pembrolizumab plus the investigator's choice of platinum agent
(carboplatin or cisplatin), and etoposide. Part B is expanded with Amendment 12 to include
evaluation of efficacy of vibostolimab plus pembrolizumab plus the investigator's choice of
platinum agent (carboplatin or cisplatin), and etoposide and efficacy of
pembrolizumab/vibostolimab coformulation in participants from mainland China. The primary
hypotheses are that vibostolimab administered as monotherapy or in combination with
pembrolizumab is safe and tolerable when administered at the RPTD and that
pembrolizumab/vibostolimab coformulation is safe and tolerable when administered as a fixed
dose.