Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
PrECOG, LLC.
Study ID
NCT03532451
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
  • Nivolumab/Lirilumab — DRUG
    Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.

Study Details

Patients with muscle-invasive bladder cancer (MIBC) who can not receive cisplatin or refuse cisplatin therapy will receive nivolumab or nivolumab/lirilumab before a planned surgical procedure called a radical cystectomy (RC) to remove the bladder. Nivolumab works by attaching to and blocking a molecule called Programmed Death-1 (PD-1). Lirilumab attaches to and blocks a group of molecules called Killer Cell Immunoglobulin-Like Receptor (KIR). PD-1 and KIR are proteins present mainly on immune system cells, and each controls part of the immune system by shutting it down. It is hoped that by binding to and inactivating these proteins, these drugs can enhance the body's ability to detect, attack and destroy cancer cells. The purpose of this research study is to see whether nivolumab alone or combination of nivolumab and lirilumab given before surgery is effective in treating people who have bladder cancer, and to examine the side effects, good and bad, associated with nivolumab and lirilumab.

Key Dates

Start date
Mar 22, 2019
Status verified
Apr 2024
Primary completion
Nov 27, 2020
Completion
Oct 5, 2022

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Nivolumab
    Nivolumab 480 mg IV on week 0 and week 4
  • Experimental: Cohort 2: Nivolumab/Lirilumab
    Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4

Primary Outcome Measure

Grade 3 or Higher Treatment Related Adverse Events as Assessed by CTCAE V5.0 [ Time Frame: 16 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10461-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
University of TX SouthwesternDallasTexas75390-
University of VirginiaCharlottesvilleVirginia22903-
University of WashingtonSeattleWashington98109-

Find similar trials in Tampa, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Moffitt Cancer Center· Tampa, FLIcahn School of Medicine at Mount Sinai· New York, NYMontefiore Medical Center· The Bronx, NYOhio State University Comprehensive Cancer Center· Columbus, OHOregon Health & Science University· Portland, ORUniversity of TX Southwestern· Dallas, TX

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