NCT04322955
CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentMark SteinInvestigator-initiated
~38 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:CabozantinibNivolumabCytoreductive nephrectomy
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with a Complete Response
Measured over Up to 5 years after completion of treatment
Conditions
Where it's being run
4 sites across 3 statesOhio2
New Jersey1
New York1
Study leadership
- Mark N Stein, MD · PRINCIPAL_INVESTIGATOR · Associate Professor of Medicine Division of Hematology/Oncology
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
Concurrent uncontrolled hypertension defined as sustained BP \> 150 mm Hg systolic, or \> 100 mm Hg diastolic despite optimal antihypertensive treatment within 14 days of the first dose of study treatment.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \>500 ms within 28 days before registration. 15. Severe active infection requiring systemic treatment within 28 days before the first dose of study treatment 16. Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment 17. Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible. 18. History of organ transplant 19. Concurrent uncompensated hypothyroidism 20. Unable to swallow tablets 21. Active infection requiring systemic therapy 22. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). 23. Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least 2 years. 24. Active central nervous system (CNS) metastases 25. Treatment with any investigational drug within 28 days prior to registration.
What this trial measures
- Percentage of Participants with a Complete ResponseUp to 5 years after completion of treatment
The percentage of participants with a complete response following treatment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.