Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Bladder cancer drug combo trial halted early – what does it mean?

NCT ID NCT04149574

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tested whether adding nivolumab (an immunotherapy drug) to standard BCG treatment could help people with high-risk bladder cancer that came back after BCG alone. Only 13 people enrolled before the study was stopped early, so we don't have clear results on whether the combination works better than BCG alone. The goal was to see if the combo could delay cancer recurrence or progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab (a drug that helps the immune system fight cancer) combined with BCG (a bacterial drug placed in the bladder)
What this could lead to
If successful, this combination could offer a new treatment option for people with high-risk bladder cancer that has not responded to standard BCG therapy.
What could go wrong
The trial was terminated early with only 13 participants, so results are very limited. It is unclear if the combination is safe or effective, and it may not lead to any new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

13 people

The number who actually took part.

Started

Jan 2020

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive * Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC) * 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 Exclusion Criteria: * Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC * UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment * UC and/or CIS in the prostatic urethra within 12 months of enrollment Other protocol-defined inclusion/exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for High-risk non-muscle-invasive urothelial carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary bladder neoplasms

Contacts and locations

Locations

  • Local Institution

    Rotterdam, 3015 GD, Netherlands

  • Local Institution - 0001

    Woolloongabba, Queensland, 4012, Australia

  • Local Institution - 0002

    Sydney, New South Wales, 2050, Australia

  • Local Institution - 0008

    Viedma, Río Negro Province, 8500, Argentina

  • Local Institution - 0009

    Caba, Buenos Aires, 1426, Argentina

  • Local Institution - 0010

    Recoleta, Santiago Metropolitan, 0, Chile

  • Local Institution - 0011

    La Serena, Coquimbo Region, 1720430, Chile

  • Local Institution - 0012

    Rimouski, Quebec, G5L 5T1, Canada

  • Local Institution - 0016

    Ciudad Autonoma Beunos Aires, Buenos Aires, 1431, Argentina

  • Local Institution - 0017

    Toronto, Ontario, M5G 1Z5, Canada

  • Local Institution - 0031

    Haidari, 12462, Greece

  • Local Institution - 0032

    Thessaloniki, 57001, Greece

  • Local Institution - 0037

    Montreal, Quebec, H3T 1E2, Canada

  • Local Institution - 0038

    Montreal, Quebec, H2X 0C2, Canada

  • Local Institution - 0040

    Villejuif, 94800, France

  • Local Institution - 0041

    Strasbourg, FR-67091, France

  • Local Institution - 0042

    Angers, 49933, France

  • Local Institution - 0045

    Lille, 59000, France

  • Local Institution - 0047

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Local Institution - 0048

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Local Institution - 0049

    Rio de Janeiro, 22793-080, Brazil

  • Local Institution - 0050

    Uberlândia, Minas Gerais, 38408-150, Brazil

  • Local Institution - 0051

    Moscow, 121309, Russia

  • Local Institution - 0052

    Saint Petersburg, 199034, Russia

  • Local Institution - 0054

    Arnhem, 6815 AD, Netherlands

  • Local Institution - 0055

    Madrid, 28041, Spain

  • Local Institution - 0057

    Santander, 39008, Spain

  • Local Institution - 0058

    Valencia, 46010, Spain

  • Local Institution - 0059

    Sabadell, 08208, Spain

  • Local Institution - 0060

    Badalona-barcelona, 08916, Spain

  • Local Institution - 0061

    Badajoz, 06006, Spain

  • Local Institution - 0062

    Milan, 20133, Italy

  • Local Institution - 0063

    Modena, 41124, Italy

  • Local Institution - 0064

    Naples, 80131, Italy

  • Local Institution - 0065

    Reggio Emilia, 42100, Italy

  • Local Institution - 0066

    Roma, 00168, Italy

  • Local Institution - 0067

    Torino, TO, 10126, Italy

  • Local Institution - 0072

    Viña del Mar, Valparaiso, 2520598, Chile

  • Local Institution - 0073

    Jerusalem, 9103102, Israel

  • Local Institution - 0074

    Ramat Gan, 52621, Israel

  • Local Institution - 0075

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Local Institution - 0080

    Buenos Aires, 1120, Argentina

  • Local Institution - 0081

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Local Institution - 0083

    Umeå, 901 85, Sweden

  • Local Institution - 0084

    The Bronx, New York, 10461, United States

  • Local Institution - 0087

    Norrköping, 601 82, Sweden

  • Local Institution - 0088

    Capital Federal, Buenos Aires, 1419, Argentina

  • Local Institution - 0093

    Jena, 07747, Germany

  • Local Institution - 0094

    Herne, 44625, Germany

  • Local Institution - 0095

    Trier, 54292, Germany

  • Local Institution - 0096

    Pamplona, Navarre, 31008, Spain

  • Local Institution - 0097

    Linz, 4010, Austria

  • Local Institution - 0098

    Wels, 4600, Austria

  • Local Institution - 0099

    Vienna, 1090, Austria

  • Local Institution - 0103

    Paris, 75679, France

  • Local Institution - 0104

    Salzburger, 5020, Austria

  • Local Institution - 0105

    Cologne, 50968, Germany

  • Local Institution - 0106

    Dijon, 21079, France

  • Local Institution - 0107

    Córdoba, 5000, Argentina

  • Local Institution - 0108

    Marseille, 13385, France

  • Local Institution - 0111

    Paris, 75018, France

  • Local Institution - 0114

    Bowral, 2576, Australia

  • The University Of Chicago

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.