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Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

NCT03117309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-07-10

Study results available
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Summary

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.

Conditions

  • Advanced Renal Cell Carcinoma

Interventions

DRUG

Nivolumab 240 mg

PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment

DRUG

Ipilimumab 1mg/kg

Ipilimumab 1 mg/kg every 3 weeks x 4

DRUG

Nivolumab 3mg/kg

In combination with Ipilimumab

DRUG

Nivolumab 360mg

Continue Nivolumab 360 mg IV every 3 weeks

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Michael B. Atkins, MD

    lead OTHER

Principal Investigators

  • Michael B. Atkins, MD · Hoosier Cancer Research Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2022-03-25
Completion
2025-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03117309 on ClinicalTrials.gov