A Study Comparing Nivolumab and Intravesical BCG to BCG Alone in High-risk Non-muscle Invasive Bladder Cancer

A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002567-96-FR

Enrollment

875

Registered

2019-11-27

Start date

2021-01-07

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial- COMMERCIAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: _Signed Written Informed Consent; _Histologically confirmed persistent or recurrent high-risk non-muscle-invasive UC (TaHG and/or T1 and/or CIS); _Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses); _Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; _Males and females, ages 18 or age of majority, and older; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 219 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 656

Exclusion criteria

Exclusion criteria: _Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured or not requiring treatment; _Patients with serious or uncontrolled medical disorders; _Participants with an active, known, or suspected autoimmune disease; _Recurrent high-risk NMIBC that is classified as BCG unresponsive; _Has any contraindication to intravesical BCG therapy, including evidence of active tuberculosis;

Design outcomes

Primary

Measure	Time frame
Main Objective: _To compare the EFS per PRC of nivolumab plus BCG vs BCG alone in all randomized participants.;Secondary Objective: _To compare the WFS of nivolumab plus BCG vs BCG alone in all randomized participants; _To compare the OS of nivolumab plus BCG vs BCG alone in all randomized participants; _To evaluate the CRR at first disease assessment (Week 13) in all randomized participants with CIS (+/- papillary disease) at study entry by treatment arm (nivolumab plus BCG and BCG alone); _evaluate the duration of response (DoR) in all randomized participants with CIS (+/- papillary disease) at study entry who achieved CRR at first disease assessment by treatment arm (nivolumab plus BCG and BCG alone); _To describe the safety and tolerability of nivolumab plus BCG and BCG alone in all treated participants.;Primary end point(s): _EFS, defined as the time from randomization until any of the following events: recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause. ;Timepoint(s) of evaluation of this end point: _recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause.	—

Measure

Time frame

Main Objective: _To compare the EFS per PRC of nivolumab plus BCG vs BCG alone in all randomized participants.;Secondary Objective: _To compare the WFS of nivolumab plus BCG vs BCG alone in all randomized participants; _To compare the OS of nivolumab plus BCG vs BCG alone in all randomized participants; _To evaluate the CRR at first disease assessment (Week 13) in all randomized participants with CIS (+/- papillary disease) at study entry by treatment arm (nivolumab plus BCG and BCG alone); _evaluate the duration of response (DoR) in all randomized participants with CIS (+/- papillary disease) at study entry who achieved CRR at first disease assessment by treatment arm (nivolumab plus BCG and BCG alone); _To describe the safety and tolerability of nivolumab plus BCG and BCG alone in all treated participants.;Primary end point(s): _EFS, defined as the time from randomization until any of the following events: recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause. ;Timepoint(s) of evaluation of this end point: _recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause.

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Secondary

Measure	Time frame
Secondary end point(s): _WFS, defined as the time from randomization to progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause; _OS, defined as the time from randomization to death from any cause; _CRR, defined as the proportion of participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment; _DoR is restricted to participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment and is defined as the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause; _Overall safety and tolerability will be measured by the incidence of AEs, SAEs, AEs leading to discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.;Timepoint(s) of evaluation of this end point: _(WFS) progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause; _(OS) death from any cause; _(CRR) first disease assessment; _(DoR ) first documented recurrence, progression, or death due to any cause; __(Overall safety and tolerability) discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.	—

Measure

Time frame

Secondary end point(s): _WFS, defined as the time from randomization to progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause; _OS, defined as the time from randomization to death from any cause; _CRR, defined as the proportion of participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment; _DoR is restricted to participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment and is defined as the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause; _Overall safety and tolerability will be measured by the incidence of AEs, SAEs, AEs leading to discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.;Timepoint(s) of evaluation of this end point: _(WFS) progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause; _(OS) death from any cause; _(CRR) first disease assessment; _(DoR ) first documented recurrence, progression, or death due to any cause; __(Overall safety and tolerability) discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactHead of the GCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026