Trial NCT07489495
A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Carcinoma, Renal Cell
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
* Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy
Exclusion Criteria:
For exclusion criteria: The main exclusion criteria include but are not limited to the following:
* Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
* Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogramCardiac
* Has had major surgery within 8 weeks before randomization
* Has current pneumonitis/interstitial lung disease
* Has a history of human immunodeficiency virus infectionHIV
* Has Hepatitis B or Hepatitis C virus infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 yearsPrior malignancy
* Has a history of solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications
Restrictions found (3)
- CardiacOutrightexclusion
LVEF ≤50%
Show in the text - HIVOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center ( Site 0139) · Boston, Suffolk County
- Dana Farber Cancer Institute ( Site 0135) · Boston, Suffolk County