Nivolumab in Combination With Ipilimumab in Patients With Metastatic Renal Cell Carcinoma

Sponsor
Swiss Cancer Institute
Study ID
NCT03297593
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    240 mg every 2 weeks during the first 20 weeks, 480 mg every 4 weeks thereafter
  • ipilimumab — DRUG
    After 2 weeks 1mg/kg every 6 weeks

Study Details

Immunotherapy with checkpoint inhibitors that target PD-1 and CTLA-4 have shown activity in mRCC. However, the optimal schedule of the combination therapy has yet to be defined. The objective of the trial is to determine the efficacy of combination immunotherapy of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma. The expansion phase shall address the role of ipilimumab in case of clinically insignificant progression.

Key Dates

Start date
Dec 13, 2017
Status verified
Jun 2025
Primary completion
Jul 1, 2019
Completion
Apr 30, 2025

Study Design

Enrollment
74 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab and ipilimumab
    Patients start treatment with nivolumab (240 mg every 2 weeks during the first 20 weeks, 480 mg every 4 weeks thereafter). After 2 weeks, ipilimumab (1mg/kg every 6 weeks) will be introduced. As soon as a radiographic complete response (CR) or partial response (PR) is observed, ipilimumab has to be stopped and only the single-agent treatment with nivolumab is continued. Once ipilumimab has been stopped because of a response, it will not be re-started later on.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: at 2 years. ]

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