Clincosm LogoSign in Get a demo

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

Sponsor
Kidney Cancer Research Bureau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04134182
Collaborator
(none)
8
Enrollment
2
Locations
1
Arm
25.5
Anticipated Duration (Months)
4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Pilot Study of the Efficacy and Safety of Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
Actual Study Start Date :
Oct 16, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nivolumab + Ipilimumab

Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.

Drug: Nivolumab
3 mg/kg intravenously every 2 weeks during 16 weeks
Other Names:
  • Opdivo

    • Drug: Ipilimumab
    1 mg/kg intravenously every 3 weeks for four doses
    Other Names:
  • Yervoy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete Response Rate [16 weeks]

      percentage of patients with localized RCC who have no tumor in kidney

    Secondary Outcome Measures

    1. Objective response rate [16 weeks]

      percentage of patients with localized RCC who have no tumor in kidney or tumor shrinkage more than 30%

    2. 3-year disease-free survival rate [3 years]

      percentage of patients who are disease free at 3 years after treatment start

    3. 5-year survival rate [5 years]

      percentage of patients who are alive at 5 years after treatment start

    4. Rate of adverse events [16 weeks]

      percentage of patients who have adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 N.N. Blokhin Russian Cancer Research Center Moscow Russian Federation
    2 Russian Scientific Center of Roentgenoradiology Moscow Russian Federation

    Sponsors and Collaborators

    • Kidney Cancer Research Bureau

    Investigators

    • Study Director: Ilya Tsimafeyeu, MD, Kidney Cancer Research Bureau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kidney Cancer Research Bureau
    ClinicalTrials.gov Identifier:
    NCT04134182
    Other Study ID Numbers:
    • KCRB16102019
    First Posted:
    Oct 22, 2019
    Last Update Posted:
    Dec 23, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Dec 23, 2020