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Brief Title: 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.

A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

INTRODUCTION

  • Org Study ID: CA045-009
  • Secondary ID: 2018-002676-40, 18-214-13
  • NTC ID: NCT04209114
  • Sponsor: Bristol-Myers Squibb
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DESCRIPTION

Who is this study for?

Patients with muscle-invasive bladder cancer who are eligible for radical cystectomy and ineligible for cisplatin therapy

What is the goal of this study?

To study the effects of the combination of drugs over time, in patients who remain free of disease complications (EFS) and overall survival.

Summary

The purpose of the study is to see if 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.

Background

MIBC patients have a 50% 5 year survival rate after radical cystectomy surgery (surgery to remove bladder and nearby tissue) and a return of cancer rate, 30-54%. 1.  Therefore, additional treatment before and/or after surgery is often considered to lower the chance that the cancer returns.  Clinical studies are research tests of an investigational drug or drugs in people.  A drug must be tested in clinical studies before it may be used for patients in the general public.

You may be eligible for this clinical study if you:

Have muscle-invasive bladder cancer, cancer that has spread to the muscle wall of the bladder

Plan to have a radical cystectomy surgery, surgery to remove bladder and nearby tissue

Do not have an autoimmune disease

Are NOT eligible for cisplatin treatment

Participation in this clinical study is determined using the full eligibility requirements. Some key eligibility requirements are above. To prescreen for this study or other bladder cancer studies, please take the Bladder Cancer Screener on BMS Study Connect.

Gender: All               Minimum Age: 18 Years       Maximum Age: N/A

Study Design

Participants enrolled in the study will be randomly assigned to one of the following study treatment arms

– Arm A: Nivolumab + Bempegaldesleukin followed by Radical cystectomy (surgery) then Nivolumab + Bempegaldesleukin

– Arm B: Nivolumab followed by Radical cystectomy (surgery) then Nivolumab

-Arm C: observation only which is the current standard of care followed by Radical cystectomy (surgery) then observation only

*Participants should have surgery within 6 weeks of completion of presurgical therapy.

*Post surgery participants will continue to receive the same study treatment they received prior to surgery

Considering a clinical study?

There is a lot to think about when considering a clinical study.  Visit BMSSTUDYCONNECT.com/ to learn more and to take a screener to see if you qualify for this or other studies.

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    February 5, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic Complete Response (pCR) rate of Arm A to Arm C

Primary Outcome 1 - Timeframe: Approximately 47 months

Primary Outcome 2 - Measure: Event-Free Survival (EFS) of Arm A vs Arm C

Primary Outcome 2 - Timeframe: Approximately 65 months

CONDITION

  • Bladder Cancer
  • Bladder Tumor
  • Muscle-Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)

- 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%
Exclusion Criteria:
Clinical evidence of ≥ N2 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

- Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)
Other protocol-defined inclusion/exclusion criteria apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: 855-907-3286

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact