Pembrolizumab/Quavonlimab

BIOLOGICAL9 trials

Conditions

Advanced Hepatocellular CarcinomaAdvanced Solid TumorsCarcinoma, Renal CellColorectal CancerMelanoma

Phase 1

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

Merck Sharp & Dohme LLCAdvanced Solid Tumors

Start: 2017-07-02End: 2024-04-08Updated: 2025-04-08

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Active, not recruitingNCT04305054

Merck Sharp & Dohme LLCMelanoma

Start: 2020-07-01End: 2026-04-20Target: 315Updated: 2025-08-29

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

Active, not recruitingNCT04626518

Merck Sharp & Dohme LLCCarcinoma, Renal Cell

Start: 2020-12-17End: 2026-05-31Target: 370Updated: 2025-07-25

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Active, not recruitingNCT04626479

Merck Sharp & Dohme LLCCarcinoma, Renal Cell

Start: 2020-12-16End: 2026-05-31Target: 400Updated: 2026-02-12

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

CompletedNCT04700072

Merck Sharp & Dohme LLCMelanoma

Start: 2021-05-03End: 2025-10-17Updated: 2025-10-28

Phase 2

Safety and Efficacy of Coformulated Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib (E7080/MK-7902) in Advanced Hepatocellular Carcinoma (MK-1308A-004)

CompletedNCT04740307

Merck Sharp & Dohme LLCAdvanced Hepatocellular Carcinoma

Start: 2021-03-16End: 2025-07-29Updated: 2025-08-13

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)

Active, not recruitingNCT04895722

Merck Sharp & Dohme LLCColorectal Cancer

Start: 2021-06-25End: 2026-08-13Updated: 2026-03-30

Phase 3

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Active, not recruitingNCT04736706

Merck Sharp & Dohme LLCCarcinoma, Renal Cell

Start: 2021-04-14End: 2026-10-29Target: 1653Updated: 2024-11-18

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study

Active, not recruitingNCT05899049

Merck Sharp & Dohme LLCCarcinoma, Renal Cell

Start: 2022-07-27End: 2027-06-07Target: 249Updated: 2025-11-10

Journal of Clinical Oncology2026-01-10

Novel pembrolizumab-based treatments as first-line therapy in advanced clear-cell renal cell carcinoma: substudy 03A of the open-label, umbrella platform, phase I/II KEYMAKER-U03 trial.

2025-10-183 citations

KEYMAKER-U03 Substudy 03B: Pembrolizumab (pembro) and targeted therapy combinations for advanced clear cell renal cell carcinoma (ccRCC).

Journal of Clinical Oncology2025-02-102 citations

KEYMAKER-U03 Substudy 03B: Pembrolizumab (pembro) and novel immunotherapy agents for advanced clear cell renal cell carcinoma (ccRCC).

Journal of Clinical Oncology2025-02-101 citations

Coformulated quavonlimab and pembrolizumab (pembro) in combination with lenvatinib (lenva) as first-line (1L) therapy for patients (pts) with advanced hepatocellular carcinoma (HCC): Phase 2 KEYSTEP-004 study.

Journal of Clinical Oncology2024-01-201 citations

LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma.

2023-10-2617 citations

KEYSTEP-008: Phase II Trial of Pembrolizumab-Based Combination in MSI-H/dMMR Metastatic Colorectal Cancer

Future Oncology2023-09-1312 citations

Belzutifan plus lenvatinib for patients (pts) with advanced clear cell renal cell carcinoma (ccRCC) after progression on a PD-1/L1 and VEGF inhibitor: Preliminary results of arm B5 of the phase 1/2 KEYMAKER-U03B study.

Journal of Clinical Oncology2023-06-0110 citations

Neoadjuvant & Adjuvant Therapy Using Pembrolizumab for Melanoma

Oncology Times2023-04-19

Update on combined immunotherapy for the treatment of advanced renal cell carcinoma.

2023-04-1627 citations

Abstract CT557: Phase 1/2 study of quavonlimab (Qmab) + pembrolizumab (pembro) in patients (pts) with advanced melanoma that progressed on a PD-1/PD-L1 inhibitor

Cancer Research2022-06-154 citations

Phase 2 study of pembrolizumab-based combination therapy in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) stage IV colorectal cancer (CRC).

Journal of Clinical Oncology2022-06-012 citations

Phase 3 study of first-line treatment with pembrolizumab + belzutifan + lenvatinib or pembrolizumab/quavonlimab + lenvatinib versus pembrolizumab + lenvatinib for advanced renal cell carcinoma (RCC).

Journal of Clinical Oncology2022-02-1613 citations

Phase 1b/2 umbrella study of investigational immune and targeted combination therapies for patients with advanced clear cell renal cell carcinoma (ccRCC).

Journal of Clinical Oncology2022-02-161 citations

417 Phase 3 study of pembrolizumab + belzutifan + lenvatinib or pembrolizumab/quavonlimab + lenvatinib versus pembrolizumab + lenvatinib as first-line treatment for advanced renal cell carcinoma

Regular and Young Investigator Award Abstracts2021-11-012 citations

Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer.

2021-07-1810 citations

Abstract CT243: A phase 1b/2 umbrella study of investigational immune and targeted combination therapies for patients with advanced renal cell carcinoma (RCC) who progressed on PD-1/L1 and VEGF inhibitors

Cancer Research2021-07-01

A phase 1b/2 umbrella study of investigational immune and targeted combination therapies as first-line therapy for patients with advanced renal cell carcinoma (RCC).

Journal of Clinical Oncology2021-05-206 citations

426 MK-3475-U02: Phase 1/2 study of investigational agents with or without pembrolizumab versus pembrolizumab monotherapy in melanoma

Regular and Young Investigator Award Abstracts2020-11-011 citations

Antitumor activity and safety of MK-1308 (anti-CTLA-4) plus pembrolizumab (pembro) in patients (pts) with non-small cell lung cancer (NSCLC): Updated interim results from a phase I study.

Journal of Clinical Oncology2019-05-201 citations

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Pembrolizumab/Quavonlimab

Sponsors

Conditions

Phase 1

Phase 2

Phase 3

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