A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK⦠(NCT04846920) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
United States52 participantsStarted 2021-06-14
Plain-language summary
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Has a histologically-confirmed diagnosis of unresectable, locally advanced/metastatic RCC with clear cell component (with or without sarcomatoid features) (may include participants with a diagnosis of von Hippel-Lindau \[VHL\] associated ccRCC).
* Has experienced disease progression on or after having received at least one previous systemic treatment for advanced ccRCC.
* Shows adequate organ function.
* Male participants are eligible to participate if they are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or is abstinent from heterosexual intercourse during the intervention period and for at least 30 days after the last dose of study intervention.
Exclusion Criteria:
* Has hypoxia, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
* Has any history of ā¦
What they're measuring
1
Percentage of Participants Who Experience at Least One Adverse Event (AE)
Timeframe: Up to ~49.5 months
2
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: Up to ~48.5 months
3
Percentage of Participants Who Modify or Interrupt Study Treatment Due to an AE
Timeframe: Up to ~48.5 months
4
Percentage of Participants Who Experience at Least One Dose-limiting Toxicity (DLT)