A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
NCT ID: NCT03634540
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
118 participants
INTERVENTIONAL
2018-09-27
2027-02-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)
Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.
Belzutifan
Belzutifan tablets administered orally.
Cabozantinib
Cabozantinib tablets administered orally.
Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)
Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.
Belzutifan
Belzutifan tablets administered orally.
Cabozantinib
Cabozantinib tablets administered orally.
Interventions
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Belzutifan
Belzutifan tablets administered orally.
Cabozantinib
Cabozantinib tablets administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 platelet count ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior 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); total bilirubin (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease \*Cohort 1: Participants must not have received prior systemic therapy for advanced or metastatic ccRCC
* Cohort 2: Participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccRCC
Exclusion Criteria
* Has received prior treatment with cabozantinib
* Has had radiation therapy for bone metastases within two weeks of starting study drug
* Has a history of untreated brain metastases or history of leptomeningeal disease or spinal 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 drug administration
* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere 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
18 Years
ALL
No
Sponsors
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Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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USC Norris Comprehensive Cancer Center ( Site 0060)
Los Angeles, California, United States
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0003)
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center ( Site 0023)
Miami, Florida, United States
Dana Farber Cancer Center ( Site 0006)
Boston, Massachusetts, United States
Karmanos Cancer Institute ( Site 0033)
Detroit, Michigan, United States
Tennessee Oncology, PLLC ( Site 0024)
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC ( Site 0001)
Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0010)
Dallas, Texas, United States
Swedish Cancer Institute ( Site 0018)
Seattle, Washington, United States
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0035)
Seattle, Washington, United States
Countries
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References
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Choueiri TK, McDermott DF, Merchan J, Bauer TM, Figlin R, Heath EI, Michaelson MD, Arrowsmith E, D'Souza A, Zhao S, Roy A, Perini R, Vickery D, Tykodi SS. Belzutifan plus cabozantinib for patients with advanced clear cell renal cell carcinoma previously treated with immunotherapy: an open-label, single-arm, phase 2 study. Lancet Oncol. 2023 May;24(5):553-562. doi: 10.1016/S1470-2045(23)00097-9. Epub 2023 Mar 31.
Choueiri TK, Merchan JR, Figlin R, McDermott DF, Arrowsmith E, Michaelson MD, Tykodi SS, Heath EI, Spigel DR, D'Souza A, Kassalow L, Perini RF, Vickery D, Bauer TM. Belzutifan plus cabozantinib as first-line treatment for patients with advanced clear-cell renal cell carcinoma (LITESPARK-003): an open-label, single-arm, phase 2 study. Lancet Oncol. 2025 Jan;26(1):64-73. doi: 10.1016/S1470-2045(24)00649-1.
Related Links
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Merck Clinical Trials Information
Other Identifiers
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PT2977-201
Identifier Type: OTHER
Identifier Source: secondary_id
MK-6482-003
Identifier Type: OTHER
Identifier Source: secondary_id
6482-003
Identifier Type: -
Identifier Source: org_study_id