New drug combo aims to wipe out kidney cancer before surgery
NCT ID NCT04322955
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving two drugs—nivolumab (immunotherapy) and cabozantinib (targeted therapy)—before removing the kidney can make all visible cancer disappear in people with advanced kidney cancer that has spread. About 38 adults with metastatic renal cell carcinoma will receive the drugs for 12 weeks, then have surgery. The goal is to see if this approach leads to a complete response, meaning no cancer remains detectable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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38 people
The number who actually took part.
- Started
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Jun 2020
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age ≥ 18years at the time of consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 28 days prior to registration. 4. Radiographically consistent with metastatic renal cell carcinoma (with subsequent pathologic confirmation of renal cell carcinoma with a clear cell component) OR histological/ cytological evidence of metastatic renal cell carcinoma with a clear cell component 5. Measurable tumor in the kidney according to RECIST 1.1 6. No prior therapy for metastatic renal cell carcinoma 7. Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 14 days prior to registration. 8. Females of childbearing potential must have a negative serum pregnancy test during screening, within 14 days of Cycle 1 Day 1. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months 9. Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. 10. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study Exclusion Criteria: 1. Patients who had previously undergone nephrectomy for renal cancer are excluded 2. Uncontrolled bleeding, hypertension, or cardiovascular disease. 3. Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4 inhibitors 4. The subject has active brain metastases or epidural disease 5. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. 6. The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test ≥1.3 x the laboratory upper limit of normal (ULN) 7. The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, thrombin or Factor Xa inhibitors. Aspirin (up to 325 mg/day), low-dose warfarin (≤1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted 8. Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment 9. Hemoptysis of ≥0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment 10. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. 11. The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib 12. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment 13. Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study start 14. Cardiovascular disorders including: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44012, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Ohio State University Wexner Medical Center
Columbus, Ohio, 43221, United States
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The Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new antibody help the immune system fight Hard-to-Treat tumors?