Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
NCT ID: NCT04134182
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
8 participants
INTERVENTIONAL
2019-10-16
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab + Ipilimumab
Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.
Nivolumab
3 mg/kg intravenously every 2 weeks during 16 weeks
Ipilimumab
1 mg/kg intravenously every 3 weeks for four doses
Interventions
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Nivolumab
3 mg/kg intravenously every 2 weeks during 16 weeks
Ipilimumab
1 mg/kg intravenously every 3 weeks for four doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kidney Cancer Research Bureau
OTHER
Responsible Party
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Principal Investigators
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Ilya Tsimafeyeu, MD
Role: STUDY_DIRECTOR
Kidney Cancer Research Bureau
Locations
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N.N. Blokhin Russian Cancer Research Center
Moscow, , Russia
Russian Scientific Center of Roentgenoradiology
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Maria Volkova, MD
Role: primary
Rustem Gafanov, MD
Role: primary
Other Identifiers
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KCRB16102019
Identifier Type: -
Identifier Source: org_study_id