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    DRUG:

    quavonlimab/pembrolizumab (MK-1308A)

    i
    Other names: MK-1308A, MK-1308/MK-3475
    Associations

    News

    Trials
    Company:
    Merck (MSD)
    Drug class:
    PD1 inhibitor, CTLA4 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1m
    Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov)
    P1/2, N=110, Recruiting, Merck Sharp & Dohme LLC | Active, not recruiting --> Recruiting | N=80 --> 110 | Trial completion date: Nov 2026 --> Nov 2029 | Trial primary completion date: Nov 2026 --> May 2026
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Lenvima (lenvatinib) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • raludotatug deruxtecan (DS-6000)
    5ms
    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=320, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Mismatch repair • Metastases
    |
    MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
    5ms
    MK-6482-012 China Extension: 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 (clinicaltrials.gov)
    P3, N=249, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jun 2027 --> Dec 2026 | Trial primary completion date: Jun 2027 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab/pembrolizumab (MK-1308A)
    7ms
    Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov)
    P1/2, N=400, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
    7ms
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=413, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    8ms
    Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98) (clinicaltrials.gov)
    P1/2, N=80, Active, not recruiting, Merck Sharp & Dohme LLC | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy
    |
    Lenvima (lenvatinib) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    8ms
    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 (clinicaltrials.gov)
    P3, N=249, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab/pembrolizumab (MK-1308A)
    8ms
    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) (clinicaltrials.gov)
    P3, N=1653, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab/pembrolizumab (MK-1308A)
    11ms
    KEYMAKER-U02 Substudy 02D: 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) (clinicaltrials.gov)
    P1/2, N=300, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • quavonlimab/pembrolizumab (MK-1308A)
    11ms
    KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) (clinicaltrials.gov)
    P1/2, N=370, Active, not recruiting, Merck Sharp & Dohme LLC | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    almost1year
    Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Merck Sharp & Dohme LLC | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
    1year
    KEYMAKER-U03B: Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) (clinicaltrials.gov)
    P1b/2, N=370, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A)
    over1year
    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 (clinicaltrials.gov)
    P3, N=249, Recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab/pembrolizumab (MK-1308A)
    almost2years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=348, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    2years
    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) (clinicaltrials.gov)
    P2, N=320, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial primary completion date • Mismatch repair
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS wild-type
    |
    Keytruda (pembrolizumab) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
    2years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=348, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jan 2024 --> Aug 2023 | Trial primary completion date: Jan 2024 --> Aug 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    almost3years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=348, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2022 --> Jan 2024 | Trial primary completion date: Jun 2022 --> Jan 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    almost3years
    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) (clinicaltrials.gov)
    P2, N=320, Recruiting, Merck Sharp & Dohme Corp. | N=240 --> 320 | Trial completion date: Sep 2024 --> Aug 2025
    Enrollment change • Trial completion date • Mismatch repair
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • RAS wild-type
    |
    Keytruda (pembrolizumab) • MK-4830 • favezelimab/pembrolizumab (MK-4280A) • quavonlimab/pembrolizumab (MK-1308A) • vibostolimab/pembrolizumab (MK-7684A)
    3years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=388, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Dec 2023 --> Jun 2022 | Trial primary completion date: Dec 2023 --> Jun 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    3years
    MK-1308A + lenvatinib and pembrolizumab + belzutifan + lenvatinib versus pembrolizumab + lenvatinib as first-line treatment for clear cell renal cell carcinoma: randomized, open-label, phase 3 study (KCRS 2021)
    Primary end points will be assessed in arm A compared with arm C and in arm B compared with arm C for patients with IMDC intermediate/poor status and in all patients regardless of IMDC status. Secondary end points are objective response rate, duration of response, patient-reported outcomes, and safety.
    Clinical • P3 data
    |
    EPAS1 (Endothelial PAS domain protein 1)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab/pembrolizumab (MK-1308A)
    over3years
    Phase 2 Basket study of Pembrolizumab or MK1308A in mCRC (clinicaltrialsregister.eu)
    P2, N=240, Ongoing, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Clinical • New P2 trial • Mismatch repair • Pan tumor
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • quavonlimab/pembrolizumab (MK-1308A)
    over3years
    Evaluation of Pembrolizumab (MK-3475) or Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008) (clinicaltrials.gov)
    P2, N=240, Recruiting, Merck Sharp & Dohme Corp. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Mismatch repair
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • quavonlimab/pembrolizumab (MK-1308A)
    over3years
    Evaluation of Pembrolizumab (MK-3475) or Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008) (clinicaltrials.gov)
    P2, N=240, Not yet recruiting, Merck Sharp & Dohme Corp.
    Clinical • New P2 trial • Mismatch repair
    |
    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • quavonlimab/pembrolizumab (MK-1308A)
    over3years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=412, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Mar 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Dec 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)
    over4years
    Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001) (clinicaltrials.gov)
    P1/2, N=328, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF V600E • BRAF V600 • ALK translocation
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • quavonlimab/pembrolizumab (MK-1308A)