A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)

Last updated: June 18, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Neoplasms

Treatment

Pembrolizumab

MK-6598

Clinical Study ID

NCT05594043
6598-001
MK-6598-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety and establish a preliminary recommended Phase 2 dose (RP2D) of MK-6598 administered as monotherapy and in combination with pembrolizumab (MK-3475) in adult participants with advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor bypathology report and has received, or been intolerant to, all treatment known toconfer clinical benefit.

  • Has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1as assessed by the local site investigator/radiology.

  • Has one or more discrete malignant lesions that are amenable to a minimum of 2separate biopsies.

  • Has a baseline tumor sample that can be submitted for analysis.

  • Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on antiretroviral therapy (ART).

  • A participant assigned male sex at birth who receives MK-6598 must agree to usecontraception and should refrain from donating sperm during the specified period(s)of at least 102 days after study interventions.

  • A participant assigned female sex at birth is eligible to participate if notpregnant or breastfeeding and at least 1 of the following: not a participant ofchildbearing potential (POCBP) or a POCBP who agrees to follow the contraceptiveguidance during the treatment period and for up to 120 days after studyintervention.

Exclusion

Exclusion Criteria:

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention or has not recovered to CTCAEVersion 5.0 Grade 1 or better from any AEs that were due to cancer therapeuticsadministered more than 4 weeks earlier (this includes participants with previousimmunomodulatory therapy with residual immune-related AEs).

  • Known additional malignancy that is progressing or has required active treatmentwithin 2 years.

  • Clinically active central nervous system (CNS) metastases and/or carcinomatousmeningitis.

  • A severe hypersensitivity (≥Grade 3) reaction to treatment with a monoclonalantibody/components of the study intervention.

  • Active infection requiring therapy.

  • History of interstitial lung disease.

  • History of (noninfectious) pneumonitis that required steroids or currentpneumonitis.

  • Active autoimmune disease that has required systemic treatment in the past 2 years.Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) isallowed.

  • Has known hepatitis B or C infections or known to be positive for hepatitis Bsurface antigen (HBsAg)/hepatitis B virus (HBV) deoxyribonucleic acid (DNA) orhepatitis C antibody or ribonucleic acid (RNA).

  • Has a history or current evidence of any condition, therapy, laboratory abnormality,or other circumstance that might confound the results of the study or interfere withthe participant's participation for the full duration of the study, such that it isnot in the best interest of the participant to participate, in the opinion of thetreating investigator.

  • Received prior radiotherapy within 2 weeks of start of study intervention, hasradiation-related toxicities requiring corticosteroids, or had a history ofradiation pneumonitis.

  • Has received a live or live-attenuated vaccine within 30 days before the first doseof study intervention. Administration of killed vaccines are allowed.

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent orwith an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg,cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137), and wasdiscontinued from that treatment due to a ≥Grade 3 immune-related AE (irAE).

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days before the start of study treatment.

  • Has had an allogeneic tissue/solid organ transplant in the last 5 years or hasevidence of graft-versus-host disease.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
December 21, 2022
Estimated Completion Date:
May 21, 2025

Connect with a study center

  • Princess Margaret Cancer Centre ( Site 0101)

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

    Genève, Geneve 1211
    Switzerland

    Site Not Available

  • Cantonal Hospital St.Gallen ( Site 0203)

    st.Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • Ospedale Regionale Bellinzona e Valli ( Site 0200)

    Bellinzona, Ticino 6500
    Switzerland

    Site Not Available

  • Cantonal Hospital St.Gallen ( Site 0203)

    Sankt Gallen, 9007
    Switzerland

    Site Not Available

  • Sanford Cancer Center ( Site 0300)

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

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