Status:
UNKNOWN
Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
Lead Sponsor:
Kidney Cancer Research Bureau
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this Phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-PD-1 antibody, and ipilimumab, an anti-CTLA-4 antibody, in T1aN0M0 clear-cell RCC patients ineligible for sur...
Detailed Description
Surgery remains the standard curative-intent therapy for localized renal cell carcinoma (RCC). Thus, systemic therapy for RCC should still be considered only in patients who have contraindications to ...
Eligibility Criteria
Inclusion
- Cytologically proven clear-cell RCC
- CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)
- Inability to perform surgery for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason
- No contradictions to nivolumab and ipilimumab
- Age 18 or older
- Written informed consent
Exclusion
- prior treatment for RCC
- pregnant or nursing
- history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., New York Heart Association class III or IV)
- evidence of metastatic disease
- local and/or systemic infections requiring antibiotics within 28 days prior to study entry
- other malignancy
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04134182
Start Date
October 16 2019
End Date
December 1 2021
Last Update
December 23 2020
Active Locations (2)
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1
N.N. Blokhin Russian Cancer Research Center
Moscow, Russia
2
Russian Scientific Center of Roentgenoradiology
Moscow, Russia