A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

Last updated: December 18, 2024
Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Overall Status: Active - Not Recruiting

Phase

2

Condition

Renal Cancer

Urologic Cancer

Carcinoma

Treatment

Cabozantinib

Belzutifan

Clinical Study ID

NCT03634540
6482-003
MK-6482-003
PT2977-201
  • Ages > 18
  • All Genders

Study Summary

This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has locally advanced or metastatic RCC with predominantly clear cell subtype

  • Has at least one measurable lesion as defined by RECIST version 1.1

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

  • Has adequate organ function defined as follows:

  • Absolute neutrophil count ≥ 1,000/µL, hemoglobin level ≥ 10 g/dL and plateletcount ≥ 100,000/µL without transfusion or growth factor support within 2 weeksprior to obtaining the hematology values at screening;

  • Serum creatinine level ≤ 2.0 × upper limit of normal (ULN)

  • Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); totalbilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease *Cohort 1:Participants must not have received prior systemic therapy for advanced ormetastatic ccRCC

  • Cohort 2: Participants must have received prior immunotherapy and no more than twoprior treatments for advanced or metastatic ccRCC

Exclusion

Exclusion Criteria:

  • Has received prior treatment with belzutifan or other HIF2α inhibitors

  • Has received prior treatment with cabozantinib

  • Has had radiation therapy for bone metastases within two weeks of starting studydrug

  • Has a history of untreated brain metastases or history of leptomeningeal disease orspinal cord compression

  • Has failed to recover from the reversible effects of prior anticancer therapy

  • Has uncontrolled or poorly controlled hypertension

  • Is receiving anticoagulant therapy

  • Has had any major cardiovascular event within 6 months prior to study drugadministration

  • Has any other clinically significant cardiac, respiratory, or other medical orpsychiatric condition that might interfere with participation in the trial orinterfere with the interpretation of trial results

  • Has had major surgery within 3 months before first study drug administration

  • Has an active infection requiring systemic treatment

  • Is participating in another therapeutic clinical trial

Study Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Cabozantinib
Phase: 2
Study Start date:
September 27, 2018
Estimated Completion Date:
February 26, 2027

Connect with a study center

  • Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003)

    Los Angeles, California 90048
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center ( Site 0060)

    Los Angeles, California 90033
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center ( Site 0023)

    Miami, Florida 33136
    United States

    Site Not Available

  • Dana Farber Cancer Center ( Site 0006)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Karmanos Cancer Institute ( Site 0033)

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Tennessee Oncology, PLLC ( Site 0024)

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Tennessee Oncology, PLLC ( Site 0001)

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035)

    Seattle, Washington 98109
    United States

    Site Not Available

  • Swedish Cancer Institute ( Site 0018)

    Seattle, Washington 98104
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.