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

Sponsor
Kidney Cancer Research Bureau
Study ID
NCT04134182
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    3 mg/kg intravenously every 2 weeks during 16 weeks
  • Ipilimumab — DRUG
    1 mg/kg intravenously every 3 weeks for four doses

Study Details

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.

Key Dates

Start date
Oct 16, 2019
Status verified
Dec 2020
Primary completion
Sep 30, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Ipilimumab
    Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.

Primary Outcome Measure

Complete Response Rate [ Time Frame: 16 weeks ]

Central Contacts

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