Kidney cancer Renal Cell Carcinoma
Conditions
Interventions
2 treatment groups
1) Belzutifan (120 mg oral, every day for 54 weeks) + Pembrolizumab (400 mg
infusion, every 6 weeks up to a maximum of 9 doses)
2) Placebo (0 mg, every day for 54 weeks) + Pembrol
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The below mentioned inclusion criteria are the most important ones. A complete list of specific inlcusion criteria can be found in the protocol. 1. Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per AJCC (8th Edition), with or without sarcomatoid features. 2. Has intermediate-high risk, high risk, or M1 NED RCC 3. Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants. 4. Must have undergone a nephrectomy and/or metastasectomy
Exclusion criteria
Exclusion criteria: The below mentioned exclusion criteria are the most important ones. A complete list of specific inlcusion criteria can be found in the protocol. 1. Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization. 2. 2. Has residual thrombus post nephrectomy in the vena renalis or vena cava. 3. 3. Has any of the following: • Pulse oximeter reading =3) reaction to belzutifan/placebo or pembrolizumab and/or any of their excipients 10. Has received prior systemic therapy for RCC 11. Has received prior radiotherapy for RCC. 12. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. 13. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention 14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention 15. Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years. 16. Has an active autoimmune disease that has required systemic treatment in past 2 years 17. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 18. Has an active infection, requiring systemic therapy. 19. Has a known history of HIV infection, a known history of Hepatitis B or known active Hepatitis C virus infection 20. 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 with the participant's participation for the full duration of the study. 21. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study 22. Has had an allogenic tissue/solid organ transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To compare disease-free survival (DFS) as assessed by investigator for participants treated with belzutifan plus pembrolizumab versus those receiving placebo plus pembrolizumab | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare overall survival (OS) - To compare the safety and tolerability profiles - To compare measures of disease recurrence-specific survival (DRSS) - To evaluate change from baseline in health-related quality of life (HRQoL) and symptoms | — |
Countries
Netherlands
Outcome results
None listed