Clinical trial · Interventional
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
NCT03634540CI-TRIAL-00083978active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma (ccRCC) | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Kidney | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cancer | — | UNRESOLVED | — |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
| Renal Cell Cancer, Recurrent | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Renal Cell Carcinoma Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belzutifan | Drug | Belzutifan | ALIAS |
| Cabozantinib | Drug | Cabozantinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Belzutifan + Cabozantinib: Treatment Naïve (Cohort 1)
- description
- Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.
- interventionNames
- Drug: Belzutifan
- Drug: Cabozantinib
- type
- EXPERIMENTAL
- label
- Belzutifan + Cabozantinib: Prior Immunotherapy (Cohort 2)
- description
- Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.
- interventionNames
- Drug: Belzutifan
- Drug: Cabozantinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 belzutifan or other HIF2α inhibitors * 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
References
Publications (2)
- RESULTChoueiri 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. PMID 37011650
- DERIVEDChoueiri 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. PMID 39756444