Clinical Trial: NCT04209114 - My Cancer Genome

NCT04209114

Description:

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

Related Conditions:

Bladder Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04209114

Trial Eligibility

Document

Title

Brief Title: A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer.
Official Title: A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Clinical Trial IDs

ORG STUDY ID: CA045-009
SECONDARY ID: 2018-002676-40
SECONDARY ID: 18-214-13
NCT ID: NCT04209114

Conditions

Bladder Cancer
Bladder Tumor
Muscle-Invasive Bladder Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	Opdivo	Combination
Bempeg	BMS-986321, NKTR-214	Combination

Purpose

Trial Arms

Name	Type	Description	Interventions
Combination	Experimental	Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg	Nivolumab Bempeg
Monotherapy	Experimental	Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab	Nivolumab
Standard-of-care	Other	RC alone, without neoadjuvant or adjuvant therapy

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder
             tumor (TURBT) and confirmed by radiographic imaging.

          -  Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to
             undergo RC. For arms A and B, participants must agree to undergo RC after completion
             of neoadjuvant therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Cisplatin-ineligible participants will be defined by any one of the following
             criteria:

             i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii)
             GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not
             available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii)
             Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing
             loss (assessed per local SOC).

        iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.

          -  Documented Left Ventricular Ejection Fraction (LVEF) more than 45%

          -  Women and men must agree to follow specific methods of contraception, if applicable

        Exclusion Criteria:

          -  Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.

          -  Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
             TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other
             intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if
             completed at least 6 weeks prior to initiating study treatment.

          -  Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal
             pelvis) or history of previous MIBC

          -  History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically
             significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic
             attack) arterial thromboembolic event

        Other protocol-defined inclusion/exclusion criteria apply

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants
Time Frame:	Approximately 36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	pCR rate of neoadjuvant nivolumab monotherapy to SOC at the time of surgery in all randomized participants
Time Frame:	Approximately 36 months
Safety Issue:
Description:

Measure:	EFS of neoadjuvant nivolumab followed by adjuvant nivolumab vs. SOC
Time Frame:	Approximately 54 months
Safety Issue:
Description:

Measure:	Overall survival
Time Frame:	Approximately 74 months
Safety Issue:
Description:

Measure:	Incidence of adverse events (AEs)
Time Frame:	Up to 5 years
Safety Issue:
Description:

Measure:	Incidence of serious adverse events (SAEs)
Time Frame:	Up to 5 years
Safety Issue:
Description:

Measure:	Incidence of AEs leading to discontinuation
Time Frame:	Up to 5 years
Safety Issue:
Description:

Measure:	Incidence of immune-mediated AEs (imAEs)
Time Frame:	Up to 5 years
Safety Issue:
Description:

Measure:	Incidence of laboratory abnormalities
Time Frame:	Up to 5 years
Safety Issue:
Description:

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Bristol-Myers Squibb

Trial Keywords

immunotherapy
NKTR-214
nivolumab
bempeg

Last Updated

August 2, 2021

Clinical Trials /

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