Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT02989714
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Interleukin-2 — DRUG
    600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart
  • Nivolumab — DRUG
    Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression

Study Details

This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab. Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate, complete response rate, and improved survival outcomes compared to either of the individual therapies.

Key Dates

Start date
Mar 16, 2017
Status verified
Jun 2021
Primary completion
Feb 25, 2019
Completion
Jun 23, 2020

Study Design

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

Arms

  • Experimental: HD IL2 and Nivolumab

Primary Outcome Measure

The Number of Patients With Grade 3 and Grade 4 Adverse Events of Interest [ Time Frame: 28 days from the first dose of Nivolumab ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
University Hospitals Seidman Cancer CenterClevelandOhio44106-
Ohio State UniversityColumbusOhio43210-

Find similar trials in Ann Arbor, MI

By condition
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By specialty
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By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIUniversity of Minnesota· Minneapolis, MNUniversity Hospitals Seidman Cancer Center· Cleveland, OHOhio State University· Columbus, OH

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