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
- Conditions
- Muscle invasive bladdercancer10038364
- Registration Number
- NL-OMON55385
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
* Participants with MIBC, clinical stage T2-T4a, N0 (< 10 mm on CT or MRI), M0,
diagnosed at TURBT within 12 weeks of randomization
* Participant must be deemed eligible for RC by urologist. Arms A and B must
agree to undergo RC after completion of neoadjuvant therapy.
* PD-L1 * 1% or PDL1 < 1% as determined by a central laboratory during the
screening period and the results must be submitted to IRT prior to
randomization. Indeterminate participants are allowed in the study.
Formalin-fixed, paraffin-embedded (FFPE) tissue block or 20 unstained tumor
tissue sections with an associated pathology report, submitted for biomarker
evaluation prior to randomization. Tumor tissue sample from a biopsy may be
fresh or a recent sample (< 12 weeks old), and should be from the TURBT or
biopsy that made the diagnosis of MIBC. No systemic therapy (e.g., adjuvant or
neoadjuvant chemotherapy) given after the sample was obtained.
* Documented left ventricular ejection fraction (LVEF) > 45% within 60 days
prior to randomization using standard echocardiogram or multigated acquisition
(MUGA) scan test
* ECOG performance status 0 or 1
* Cisplatin-ineligible participants:
- Impaired renal function (GFR * 30 but < 60 mL/min); GFR should be assessed
by direct measurement or, if not available, by calculation from serum/plasma
creatinine
- CTCAE version 5, * Grade 2 hearing loss
- CTCAE version 5, * Grade 2 peripheral neuropathy
* Clinical evidence of pathologic LN (* 10 mm in short axis) or metastatic
bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer
other than TURBT or biopsies is not permitted. Prior BCG or other intravesical
treatment of NMIBC is permitted if completed at least 6 weeks prior to
initiating study treatment
* Evidence of UC in upper urinary tracts (ureters or renal pelvis) or history
of previous MIBC.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* pCR rate, defined by the proportion of randomized participants with absence<br /><br>of any cancer (T0, N0,M0) in pathology specimens after RC, based on blinded<br /><br>independent pathology review<br /><br>* EFS, defined as the time from randomization to any of the following events:<br /><br>progression of disease that precludes surgery, local or distant recurrence<br /><br>based on BICR assessments, or death due to any cause</p><br>
- Secondary Outcome Measures
Name Time Method <p>* pCR rate, defined by the proportion of randomized participants with absence<br /><br>of any cancer (T0, N0,M0) in pathology specimens after RC, based on blinded<br /><br>independent pathology review<br /><br>* EFS, defined as the time from randomization to any of the following events:<br /><br>progression of disease that precludes surgery, local or distant recurrence<br /><br>based on BICR assessments, or death due to any cause<br /><br>* OS, defined as the time between the date of randomization and the date of<br /><br>death from any cause. OS will be censored on the last date a subject was known<br /><br>to be alive.<br /><br>* Worst grade AEs, SAEs, AEs leading to discontinuation, immune-mediation AEs<br /><br>and worst grade clinical laboratory values</p><br>