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

NCT03075423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2025-09-26

No results posted yet for this study

Summary

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).

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Ipilimumab plus nivolumab

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

DRUG

Standard Therapy

Standard of Care therapy is administered according to the physician´s decision.

Sponsors & Collaborators

  • Goethe University

    lead OTHER

Principal Investigators

  • Lothar Bergmann, MD · Goethe University (Hospital) Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2023-11-23
Completion
2023-11-23

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075423 on ClinicalTrials.gov