Renal Cell Carcinoma
Conditions
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 surgical treatment.
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 surgery. Results of Phase 3 CheckMate 214 study showed that a combination of nivolumab and ipilimumab has a significant impact on tumor burden in intermediate- and poor-risk metastatic RCC patients with a complete response rate of 11% (Motzer et al. Lancet Oncology 2019). Median time to objective response was 2.8 months. Among all complete responders to nivolumab plus ipilimumab in the intention-to-treat population, 5% achieved a complete response at the first scan, whereas most converted from the partial response at a median of 6.9 months or from the stable disease at a median of 11.3 months. We hypothesize that this combination could completely eliminate primary tumors in patients with small primary (less than 4 cm) ineligible for surgical treatment. There are no studies evaluating checkpoint inhibitors in this setting in RCC patients.
Interventions
DRUGNivolumab
3 mg/kg intravenously every 2 weeks during 16 weeks
DRUGIpilimumab
1 mg/kg intravenously every 3 weeks for four doses
Sponsors
Kidney Cancer Research Bureau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | 16 weeks | percentage of patients with localized RCC who have no tumor in kidney |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 16 weeks | percentage of patients with localized RCC who have no tumor in kidney or tumor shrinkage more than 30% |
| 3-year disease-free survival rate | 3 years | percentage of patients who are disease free at 3 years after treatment start |
| 5-year survival rate | 5 years | percentage of patients who are alive at 5 years after treatment start |
| Rate of adverse events | 16 weeks | percentage of patients who have adverse events |
Countries
Russia
Contacts
Primary ContactIlya Tsimafeyeu, MD
Outcome results
None listed