Randomized Phase-II Study of Nivolumab Plus Ipilimumab vs. Standard of Care in Untreated and Advanced Non-clear Cell RCC

Sponsor
Goethe University
Study ID
NCT03075423
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab plus nivolumab — DRUG
    Ipilimumab every 3 weeks for 4 times Nivolumab every 3 weeks for 4 times followed by maintenance therapy with nivolumab every 2nd or 4th week
  • Standard Therapy — DRUG
    Standard of Care therapy is administered according to the physician´s decision.

Study Details

SUNNIFORECAST (Standard of Care vs. Nivolumab + Ipilimumab as First line treatment of renal cell cancer of non-clear cell subtypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC).

Key Dates

Start date
Nov 1, 2017
Status verified
Sep 2025
Primary completion
Nov 23, 2023
Completion
Nov 23, 2023

Study Design

Enrollment
316 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab plus nivolumab
    Ipilimumab 1mg/kg plus nivolumab 3mg/kg, both, will be administered i.v. every 3 weeks for 4 times as an induction therapy followed by a maintenance therapy with a fixed dose of 240 mg nivolumab every two weeks or 480 mg every four weeks until progression.
  • Active Comparator: Standard of Care therapy
    Standard of Care therapy is administered according to the physician´s decision.

Primary Outcome Measure

Overall survival rate at 12 months (OS12) (landmark) [ Time Frame: 12 months ]

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