CA045-009: Nivo plus NKTR-214 in MIBC Cisplatin ineligible pts
Research type
Research Study
Full 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
IRAS ID
1003322
Contact name
Naveed Sarwar
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-002676-40
Clinicaltrials.gov Identifier
Research summary
About 20%-25% of patients diagnosed with urothelial carcinoma (UC) present with
MIBC, defined as stage T2-T4a, N0, M0. For patients who are ineligible to receive
cisplatin-based chemotherapy, the primary treatment for these patients is RC, without
any neoadjuvant therapy.
Although this can be curative for some, up to 50% of patients ultimately develop
recurrent,metastatic disease. This Phase 3 study wants to test the effectiveness, safety,
and tolerability of the investigational drug called NKTR-214, when combined with
nivolumab versus nivolumab given alone both before and after radical cystecomy versus
standard of care. At this time, the only treatment approved is radical cycstectomy
(surgery to remove urinary bladder).
The study of nivolumab and NKTR-214 followed by continued adjuvant nivolumab and
NKTR-214 after RC, aims to demonstrate that treatment with nivolumab combined with
NKTR-214 will significantly increase the rate of pathologic complete response (no
residual cancer in the body) and prolong Event Free Survival (presence of recurrence).
In this trial, patients will undergo screening tests to check that it is safe for them to take
part in the trial. Those patients who are suitable will be randomly allocated to receive
either nivolumab + NKTR-214 or Nivolumab alone or only undergo the cystectomy (no
treatment given).
Patients will undergo the following procedures during the study: tumour tissue biopsy
(possible), cystectomy (surgical removal of the bladder), CT/MRI scans, ECG or MUGA,
intravenous infusion of study drug, physical exams, blood sampling for routine safety
testing and study specific testing.
540 patients are to be treated in the study with approximately 45 to be treated in the UK.
The study is sponsored by Bristol Myers Squibb.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0938
Date of REC Opinion
4 Sep 2020
REC opinion
Further Information Favourable Opinion