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    DRUG:

    quavonlimab (MK-1308)

    i
    Other names: MK1308, MK 1308, MK-1308, AK107, AK-107
    Company:
    Akesobio, Merck (MSD)
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    16d
    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)
    4ms
    KEYMAKER-U02 Substudy 02A: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02) (clinicaltrials.gov)
    P1/2, N=200, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Vesanoid (tretinoin) • quavonlimab (MK-1308) • vibostolimab (MK-7684)
    6ms
    LITESPARK-012: pembrolizumab plus lenvatinib with or without belzutifan or quavonlimab for advanced renal cell carcinoma. (PubMed, Future Oncol)
    Results from this study may support triplet combination therapies as a potential new standard of care for advanced ccRCC. Clinical trial registry: NCT04736706 (ClinicalTrials.gov).
    Review • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Welireg (belzutifan) • quavonlimab (MK-1308)
    8ms
    KEYSTEP-008: phase II trial of pembrolizumab-based combination in MSI-H/dMMR metastatic colorectal cancer. (PubMed, Future Oncol)
    Here we describe the design and rationale for the open-label, randomized, phase II KEYSTEP-008 trial, which will evaluate the efficacy and safety of pembrolizumab-based combination therapy compared with pembrolizumab monotherapy in chemotherapy-refractory (cohort A) or previously untreated (cohort B) MSI-H/dMMR mCRC. Clinical Trial Registration: NCT04895722 (ClinicalTrials.gov).
    P2 data • Review • Journal • Metastases
    |
    MSI (Microsatellite instability) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308) • vibostolimab (MK-7684) • MK-4830 • favezelimab/pembrolizumab (MK-4280A)
    10ms
    Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. (PubMed, Nat Med)
    Patients were categorized by T-cell-inflamed gene expression profile (TcellGEP) and tumor mutational burden (TMB) status and randomly assigned 1:1:1 to receive pembrolizumab + lenvatinib, pembrolizumab + quavonlimab or pembrolizumab + favezelimab. These data demonstrate the feasibility of prospective TcellGEP and TMB assessment to study the clinical activity of first-line pembrolizumab-based combination therapies in advanced NSCLC. ClinicalTrials.gov registration: NCT03516981 .
    P2 data • Journal • Combination therapy • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • favezelimab (MK-4280) • quavonlimab (MK-1308) • favezelimab/pembrolizumab (MK-4280A)
    1year
    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)
    over1year
    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)
    almost2years
    A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov)
    P2, N=318, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement
    |
    Lenvima (lenvatinib) • favezelimab (MK-4280) • quavonlimab (MK-1308) • favezelimab/pembrolizumab (MK-4280A)
    2years
    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). (ASCO 2022)
    This ongoing, open-label, multicenter, multiarm, randomized, phase 2 trial (NCT04895722) will evaluate efficacy and safety of coformulated pembro and anti–CTLA-4 quavonlimab compared with pembro monotherapy in chemotherapy-refractory stage IV dMMR/MSI-H CRC in cohort A; the study will also evaluate the efficacy and safety of 4 pembro-based combinations (coformulation of pembro with either quavonlimab, anti–LAG-3 favezelimab, or anti-TIGIT vibostolimab; anti-ILT4 MK-4830 given sequentially with pembro) compared with pembro monotherapy in previously untreated stage IV dMMR/MSI-H CRC in cohort B. Pts aged ≥18 y with histologically confirmed stage IV dMMR/MSI-H CRC who have measurable disease per RECIST v1.1 by investigator and confirmed by blinded independent central review (BICR), will be enrolled. Pts in cohort A must have experienced PD after fluoropyrimidine, irinotecan, and oxaliplatin, with or without anti-VEGF antibody, and anti-EGFR antibody for pts with left-sided tumors that are RAS WT...For both cohorts, primary end point is ORR by BICR per RECIST v1.1; secondary end points are ORR assessed by investigator, DOR and PFS assessed by BICR and by investigator per RECIST v1.1, OS, and safety and tolerability graded per NCI CTCAE v5.0. Enrollment in this trial is ongoing.
    Clinical • P2 data • Combination therapy • Mismatch repair • Microsatellite instability • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    MSI-H/dMMR • RAS wild-type
    |
    Keytruda (pembrolizumab) • oxaliplatin • irinotecan • favezelimab (MK-4280) • quavonlimab (MK-1308) • vibostolimab (MK-7684) • MK-4830
    2years
    A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov)
    P2, N=318, Active, not recruiting, Merck Sharp & Dohme Corp. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Oct 2025 | Trial primary completion date: Feb 2025 --> Oct 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement
    |
    Lenvima (lenvatinib) • favezelimab (MK-4280) • quavonlimab (MK-1308) • favezelimab/pembrolizumab (MK-4280A)
    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 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)
    over2years
    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)
    over2years
    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. (PubMed, Lung Cancer)
    Encouraging antitumor activity was observed with quavonlimab + pembrolizumab in patients with extensive-stage SCLC; responses were observed in PD-L1-positive and PD-L1-negative tumors. The combination was tolerable with manageable toxicities.
    Clinical • P1 data • Clinical Trial,Phase I • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308)
    3years
    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)
    over3years
    A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) (clinicaltrials.gov)
    P2, N=318, Recruiting, Merck Sharp & Dohme Corp. | Trial completion date: Jan 2023 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Tumor Mutational Burden • PD(L)-1 Biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • favezelimab (MK-4280) • quavonlimab (MK-1308) • favezelimab/pembrolizumab (MK-4280A)
    over3years
    Safety and Efficacy of Quavonlimab, a Novel Anti-CTLA-4 Antibody (MK-1308), in Combination with Pembrolizumab in First-Line Advanced Non-Small Cell Lung Cancer. (PubMed, Ann Oncol)
    Quavonlimab 25 mg Q6W plus pembrolizumab demonstrated similar efficacy and a better safety profile among all quavonlimab doses/schedules evaluated; this regimen was the chosen RP2D.
    Clinical • Journal • Combination therapy • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • quavonlimab (MK-1308)
    4years
    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)