vibostolimab/pembrolizumab (MK-7684A)

P2, N=255, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

P3, N=1264, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jun 2028 --> Dec 2026 | Trial primary completion date: Apr 2026 --> Dec 2026

P3, N=1246, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

Background In the multicohort phase 2 KEYVIBE-005 study (NCT05007106), the antitumor activity of vibostolimab (anti-T-cell immunoreceptor with Ig and ITIM domains [TIGIT]) coformulated with pembrolizumab (anti–PD-1; vibostolimab/pembrolizumab) was demonstrated in patients with previously treated advanced mismatch repair–deficient (dMMR) endometrial cancer (cohort B1; n = 40; ORR, 64%) and in patients with previously untreated advanced esophageal cancer treated with vibostolimab/pembrolizumab plus 5-fluorouracil and cisplatin (cohort E; n = 40; ORR, 53%). Ethics Approval The study protocol and all amendments were approved by the institutional review board or ethics committee at each institution. Consent All patients provided written informed consent.

P2, N=255, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Aug 2027 --> Oct 2024

P2, N=180, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024

P1, N=470, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed

P2, N=610, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting | Trial completion date: Feb 2027 --> Aug 2026 | Trial primary completion date: Feb 2027 --> Aug 2026

P1/2, N=80, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

P2, N=320, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P3, N=700, Active, not recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Nov 2025 --> Jun 2026

P3, N=1594, Active, not recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Oct 2027 --> Mar 2024

P3, N=1560, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

In pts with CC with PD-L1 CPS ≥1, all biomarkers trended towards a positive association with response to vibo/pembro; the strongest associations were observed for PD-L1 and TcellinfGEP. Trends towards larger ctDNA decreases were observed with vibo/pembro vs pembro.

P1/2, N=80, Not yet recruiting, Merck Sharp & Dohme LLC

P1, N=492, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2024 --> Aug 2024 | Trial primary completion date: Oct 2024 --> Aug 2024

P1/2, N=400, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=390, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=400, Recruiting, Merck Sharp & Dohme LLC | Phase classification: P1b/2 --> P1/2

P3, N=450, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=390, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

No abstract available

P3, N=700, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P1/2, N=390, Not yet recruiting, Merck Sharp & Dohme LLC

P2, N=255, Active, not recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: May 2023 --> Jan 2023

P1/2, N=390, Ongoing, Merck Sharp & Dohme LLC

P2, N=320, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Sep 2024 --> Sep 2025

The results of this study will elucidate the role and PK characteristics of the coformulation of vibostolimab and pembrolizumab in R/R hematologic malignancies.

P2, N=240, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting

P3, N=784, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

P3, N=1246, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Apr 2027 --> Jun 2028

P1, N=492, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting

P3, N=1246, Recruiting, Merck Sharp & Dohme Corp. | N=598 --> 1246 | Trial primary completion date: Apr 2025 --> Apr 2026

P3, N=784, Not yet recruiting, Merck Sharp & Dohme Corp.

The current phase 3 study (KeyVibe-003; ClinicalTrials.gov, NCT04738487) is comparing first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1-positive metastatic NSCLC. This randomized, multicenter, double-blind study is enrolling adults with pathologically confirmed, previously untreated, metastatic NSCLC with PD-L1 TPS ≥1% (centrally confirmed). N/A

P3, N=700, Ongoing, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

P2, N=320, Recruiting, Merck Sharp & Dohme Corp. | N=240 --> 320 | Trial completion date: Sep 2024 --> Aug 2025

Background: The T-cell immunoglobulin and ITIM domain (TIGIT) is highly coexpressed with programmed cell death 1 (PD-1) on both CD4 and CD8 T cells in cancers. In the part 2 dose-expansion phase, the plan is to enroll approximately 120 patients from cohorts B-E to receive up to 35 cycles of MK-7684A Q3W; 30 additional patients may be enrolled in a cohort expansion (cohort G) to receive vibostolimab monotherapy Q3W for up to 35 cycles. Cohort G will include patients with cHL or PMBCL with PD after ≥2 or ≥3 prior therapies, FL after ≥2 prior therapies, DLBCL after ≥2 prior therapies, and/or MM after ≥3 prior therapies.

P2, N=180, Recruiting, Merck Sharp & Dohme Corp. | Not yet recruiting --> Recruiting

The current phase 3 study (NCT04738487) is comparing first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1–positive metastatic NSCLC. Enrollment began in April of 2021, and is ongoing at 42 sites in 11 countries. Trial Registration ClinicalTrials.gov, NCT04738487

The current phase 3 study (NCT04738487) is comparing the efficacy and safety of first-line treatment with MK-7684A, a co-formulation of vibostolimab plus pembrolizumab, versus pembrolizumab monotherapy in patients with PD-L1-positive metastatic NSCLC. Approximately 598 patients will be randomized. Enrollment began in April of 2021.

P2, N=480, Ongoing, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.