Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 surgical treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kidney Cancer Research Bureau
• Treatments: Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

1. Cytologically proven clear-cell RCC

2. CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0)

3. 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

4. No contradictions to nivolumab and ipilimumab

5. Age 18 or older

6. Written informed consent

Exclusion Criteria:

1. prior treatment for RCC

2. pregnant or nursing

3. 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)

4. evidence of metastatic disease

5. local and/or systemic infections requiring antibiotics within 28 days prior to study entry

6. other malignancy