Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study)

Part of paid clinical trials in La Jolla, California.

Sponsor
Toni Choueiri, MD
Study ID
NCT03203473
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells
  • Nivolumab — DRUG
    Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs

Study Details

This research study is studying two drugs at different time points as a possible treatment for advanced renal cell cancer The drugs involved in this study are: Nivolumab Ipilimumab

Key Dates

Start date
Oct 26, 2017
Status verified
Jan 2026
Primary completion
Nov 30, 2021
Completion
Jun 28, 2026

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Overall cohort: Initial Primary Treatment with Nivolumab (induction phase)
    * Therapy with nivolumab IV every 2 weeks * Serial imaging assessments every 8 weeks * After confirmatory scans, patients are assigned to Arm A or Arm B.
  • Experimental: Arm A: Observation Arm (for patients with persistent response to induction nivolumab)
    Patients with persistent response (complete or partial response) to induction nivolumab are assigned to Arm A (Observation Arm). * Patients discontinued nivolumab after allocation to Arm A. * Serial imaging assessments every 8 weeks. * If scans persistently show PR/CR, patients remained on observation. * If progressive disease develops, therapy with nivolumab (480 mg IV every 4 weeks) will be resumed. * If there is subsequent progression on nivolumab monotherapy, ipilimumab (1 mg/kg IV every 3 weeks x 2 doses) is added. * If progression after nivolumab + ipilimumab, therapy discontinued. If SD/PR/CR, nivolumab is continued until progression.
  • Experimental: Arm B: Nivolumab+Ipilimumab then nivolumab alone (for patients with SD/PD to induction nivolumab)
    Patients with confirmed SD/PD to induction nivolumab are allocated to Arm B (Combination Therapy Arm). * In combination therapy, patients received nivolumab 3 mg/kg and ipilimumab 1 mg/kg intravenously every 3 weeks for two doses. * After then nivolumab will be continued at 480 mg IV every 4 weeks until disease progression. * Arm B patients undergo imaging at 12 weeks and then every 8 weeks.

Primary Outcome Measure

Percentage of Subjects With Persistent Partial Response (PR) or Complete Response (CR) at 1 Year Since Nivolumab Discontinuation (Arm A Only) [ Time Frame: From nivolumab discontinuation until 1 year after discontinuation with nivolumab ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of Chicago Medical CenterChicagoIllinois60637-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Lifespan Comprehensve Cancer CenterProvidenceRhode Island02903-
University of Utah, Huntsman Cancer CenterSalt Lake CityUtah84112-
Unviersity of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in La Jolla, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of California, San Diego Moores Cancer Center· La Jolla, CAUniversity of Chicago Medical Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAUniversity of North Carolina at Chapel Hill· Chapel Hill, NCLifespan Comprehensve Cancer Center· Providence, RI

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