vibostolimab/pembrolizumab (MK-7684A) / Merck (MSD) - LARVOL DELTA

KEYVIBE 007: Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) (clinicaltrials.gov) - P3 | N=739 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Coformulated vibostolimab/pembrolizumab plus chemotherapy as first-line therapy vs atezolizumab plus chemotherapy for extensive-stage small-cell lung cancer (ES-SCLC): randomized, phase 3 KEYVIBE-008 (SITC 2024) - P3 | "Background Etoposide with platinum-chemotherapy (EP) plus immunotherapy (e.g. atezolizumab) is the recommended treatment for ES-SCLC.1 First-line pembrolizumab plus EP significantly improved PFS but not OS vs placebo plus EP in ES-SCLC in the KEYNOTE-604 study.2 Vibostolimab, an anti–T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) antibody, showed antitumor activity with pembrolizumab in NSCLC.3 The KEYVIBE-008 study evaluated vibostolimab coformulated with pembrolizumab (vibostolimab/pembrolizumab) plus EP as first-line therapy for ES-SCLC (NCT05224141). Methods Patients (≥18 years) with histologically/cytologically confirmed untreated ES-SCLC were randomized 1:1 to vibostolimab/pembrolizumab (200 mg each) Q3W or atezolizumab 1200 mg Q3W; patients also received EP (cisplatin or carboplatin) for the first 4 cycles...All patients provided written informed consent before enrollment. An external independent data and safety monitoring committee..."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • TIGIT

A multicohort, open-label, phase 2 basket study of the coformulation of vibostolimab with pembrolizumab, with or without other anticancer therapies, in select solid tumors (AACR 2022) - P2 | "Enrollment is ongoing. >"

Clinical • IO biomarker • P2 data • Pan tumor • Oncology • Solid Tumor • CD4 • CD8 • TIGIT

A randomized, double-blind, phase 3 trial of MK-7684A plus chemotherapy versus pembrolizumab plus chemotherapy as first-line therapy for metastatic non–small cell lung cancer (NSCLC): KeyVibe-007. (ASCO 2022) - P3 | "Patients are randomized 1:1 to receive MK-7684A (MK-7684 200 mg + pembro 200 mg) IV or pembro 200 mg IV plus chemotherapy (squamous: carboplatin area under the curve [AUC] 6 mg/mL/min plus paclitaxel 200 mg/m2 or nab-paclitaxel 100 mg/m2 [days 1, 8, 15]; nonsquamous: pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min) Q3W for 4 cycles followed by MK-7684A or pembro Q3W, per randomized therapy, for up to 31 additional cycles (plus continued pemetrexed maintenance, nonsquamous only) or until PD, unacceptable AEs, investigator decision, or patient withdrawal. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. Enrollment is ongoing."

Clinical • IO biomarker • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • NECTIN2 • PD-L1 • PVR • ROS1 • TIGIT

Coformulated vibostolimab/pembrolizumab in advanced cervical cancer: KEYVIBE-005 (ESMO-GC 2024) - P2 | "Efficacy outcomes with coformulated vibo/pembro were not superior to pembro in pts with previously treated PD-L1+ cervical cancer, consistent with that observed in other anti-TIGIT trials. No new safety signals were identified."

Metastases • Cervical Cancer • Oncology • Septic Shock • Solid Tumor • PD-L1 • TIGIT

Vibostolimab coformulated with pembrolizumab versus pembrolizumab alone as adjuvant therapy for high-risk stage IIB to IV melanoma in the phase 3 KEYVIBE-010 trial: results from participants enrolled in China (ESMO Asia 2025) - P3 | "In Chinese pts with resected stage IIB-IV melanoma, adjuvant vibo/pembro did not provide additional clinical benefit vs pembro alone, consistent with the global population. Pembro monotherapy remains a standard of care in this setting."

Clinical • P3 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • TIGIT

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=296 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

VIBOSTOLIMAB AND PEMBROLIZUMAB COFORMULATION COMBINED WITH LENVATINIB FOR MISMATCH REPAIR-PROFICIENT ADVANCED ENDOMETRIAL CANCER: RESULTS FROM COHORT B2 OF THE PHASE 2 KEYVIBE-005 STUDY (IGCS 2025) - P2 | "40 participants received ≥1 dose of treatment (80% received only 1-line prior therapy, any setting [68% prior (neo)adjuvant therapy]). Median follow-up was 41.5 (range, 40.0-45.6) months at data cutoff (August 5, 2025). ORR per investigator was 43% (95% CI, 27%-59%) (Table 1)."

Late-breaking abstract • Metastases • Mismatch repair • P2 data • pMMR • Endometrial Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI • TIGIT

Biomarker analysis of coformulation of vibostolimab with pembrolizumab (vibo/pembro) with or without docetaxel for metastatic non–small-cell lung cancer (mNSCLC) after chemotherapy and immunotherapy (SITC 2025) - P2 | "Additional biomarker data will be presented.Conclusions These biomarker analyses showed that higher TIGIT IHC was associated with numerically longer PFS and OS in participants with mNSCLC previously treated with an anti-PD-(L)1 and platinum-based chemotherapy receiving vibo/pembro with docetaxel; this benefit was not observed with vibo/pembro alone.Trial Registration ClinicalTrials.gov identifier, NCT04725188Ethics Approval The study was conducted in accordance with principles of Good Clinical Practice and approved by the appropriate institutional review boards and regulatory agencies. All participants provided written informed consent before enrolling.Abstract 508 Table 1View inline•Open as popupPFS and OS HRa estimates for biomarker subgroups"

Biomarker • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1 • TIGIT

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

KEYMAKER-U03 sub-study 03A: Triplet investigational combinations of immunotherapy and targeted treatments as first-line therapy for advanced renal cell carcinoma (Eurekalert) - "This sub-study enrolled 353 patients with advanced ccRCC who were randomly assigned to receive one of the following four investigational combinations, or standard treatment, as first-line therapy: Favezelimab-pembrolizumab + lenvatinib; vibostolimab-pembrolizumab + lenvatinib; quavonlimab-pembrolizumab + lenvatinib; pembrolizumab + belzutifan + lenvatinib, or pembrolizumab + lenvatinib....The pembrolizumab-belzutifan-lenvatinib triplet demonstrated promising antitumor activity with an objective response rate (ORR) of 78% and a median progression-free survival (PFS) of 31.8 months as compared to 20.8 months in the reference arm. The pembrolizumab/quavonlimab plus lenvatinib group showed an ORR of 71%, but median PFS was similar to the control arm. The efficacy of the other two combinations was less favorable."

P1/2 data • Clear Cell Renal Cell Carcinoma

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2030 ➔ Oct 2025 | Trial primary completion date: Aug 2026 ➔ Oct 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PD-L1

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2026 ➔ Sep 2025

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2025 ➔ Sep 2026

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Vibostolimab Coformulated with Pembrolizumab in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: KEYNOTE-365 Cohort G. (PubMed, Eur Urol Focus) - P1/2 | "We found that this combination had limited antitumor activity, with side effects as expected for the two drugs individually. The KEYNOTE-365 trial is registered on ClinicalTrials.gov as NCT02861573."

Journal • Cardiovascular • Castration-Resistant Prostate Cancer • Dermatology • Genito-urinary Cancer • Oncology • Prostate Cancer • Pruritus • Pulmonary Embolism • Respiratory Diseases • Solid Tumor

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) (clinicaltrials.gov) - P2 | N=613 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008) (clinicaltrials.gov) - P2 | N=302 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 ➔ Apr 2026 | Trial primary completion date: Jun 2026 ➔ May 2025

dMMR • Mismatch repair • MSI-H • Trial completion date • Trial primary completion date • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) (clinicaltrials.gov) - P2 | N=613 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2026 ➔ Aug 2025 | Trial primary completion date: Aug 2026 ➔ Aug 2025

Pan tumor • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010) (clinicaltrials.gov) - P3 | N=1594 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Mar 2031 ➔ Aug 2025

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

KEYVIBE-006: Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006) (clinicaltrials.gov) - P3 | N=611 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 ➔ Aug 2026 | Trial primary completion date: Sep 2028 ➔ Aug 2026

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003) (clinicaltrials.gov) - P3 | N=1264 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Dec 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Sep 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-1 • PD-L1 • ROS1

KEYVIBE 007: Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007) (clinicaltrials.gov) - P3 | N=739 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2027 ➔ Jan 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2024

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01) (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Merck Sharp & Dohme LLC | N=60 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Tumor mutational burden • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Oncology • Pediatrics • Solid Tumor

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) (clinicaltrials.gov) - P3 | N=784 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057) (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor