A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04209114
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Radical cystectomy (RC) — PROCEDURE
    Surgical removal of the bladder
  • Bempegaldesleukin — BIOLOGICAL
    Specified dose on specified days

Study Details

The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

Key Dates

Start date
Feb 5, 2020
Status verified
Jun 2024
Primary completion
Jun 7, 2023
Completion
Jun 7, 2023

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Combination Therapy
    Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg
  • Experimental: Arm B: Monotherapy
    Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab
  • Other: Arm C: Standard-of-care
    RC alone, without neoadjuvant or adjuvant therapy

Primary Outcome Measure

Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care [ Time Frame: From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Local Institution - 0080GilbertArizona85234-
Local Institution - 0136TucsonArizona85724-
Local Institution - 0029La JollaCalifornia92092-0698-
Local Institution - 0015OrangeCalifornia92868-
Local Institution - 0002Iowa CityIowa52242-
Local InstitutionRochesterMinnesota55905-
Local Institution - 0006New BrunswickNew Jersey08903-
Local Institution - 0004BuffaloNew York14263-
Local Institution - 0009The BronxNew York10461-
Local Institution - 0005AllentownPennsylvania18103-
Local Institution - 0007CharlestonSouth Carolina29425-
Local Institution - 0139HoustonTexas77030-
Local Institution - 0023TempleTexas76508-
Local Institution - 0122Gig HarborWashington98332-
Local Institution - 0102SeattleWashington98109-

Find similar trials in Gilbert, AZ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Local Institution - 0080· Gilbert, AZLocal Institution - 0136· Tucson, AZLocal Institution - 0029· La Jolla, CALocal Institution - 0015· Orange, CALocal Institution - 0002· Iowa City, IALocal Institution· Rochester, MN

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