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Bladder cancer umbrella trial tests immunotherapy combos

NCT ID NCT03869190

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tested several immunotherapy-based drug combinations in 272 people with advanced bladder cancer that had worsened after platinum chemotherapy. The goal was to see which combinations were safest and most effective at shrinking tumors or slowing the disease. Participants received atezolizumab (an immunotherapy) alone or paired with other drugs like enfortumab vedotin, niraparib, or tiragolumab. The flexible 'umbrella' design allowed researchers to add or drop treatment arms based on early results.

What this could mean

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

Active substance
Atezolizumab (an immunotherapy drug) combined with other drugs like enfortumab vedotin, niraparib, or tiragolumab
What this could lead to
If successful, this could identify better combination treatments for advanced bladder cancer, potentially improving response rates and delaying disease progression.
What could go wrong
This is an early-phase (1b/2) umbrella study with many different drug combos, so results are preliminary. Some combinations may cause severe side effects or show limited benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

272 people

The number who actually took part.

Started

Jun 2019

Finished

Dec 2025

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 for mUC Cohort: * Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra) * Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing * Disease progression during or following treatment with no more than one platinum-containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence * ECOG Performance Status of 0 or 1 * Measurable disease (at least one target lesion) according to RECIST v1.1 * Adequate hematologic and end-organ function * Negative HIV test at screening * Negative total hepatitis B core antibody (HBcAb) test and hepatitis C virus (HCV) antibody at screening * Tumor accessible for biopsy * For women of childbearing potential: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating eggs * For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Inclusion Criteria for MIBC Cohorts: * ECOG PS of 0 or 1 * Fit and planned-for cystectomy * Histologically documented MIBC (pT2-4, N0, M0), also termed TCC or urothelial cell carcinoma of the urinary bladder * N0 or M0 disease by CT or MRI * Adequate hematologic and end-organ function * Availability of TURBT specimen * Negative HIV, HBcAb, and HCV test at screening * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Exclusion Criteria for mUC Cohort: * Prior treatment with a T-cell co-stimulating therapy or a CPI including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Prior treatment with any of the protocol-specified study treatments including treatment with poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor, nectin-4 targeting agents, signal regulatory protein alpha-targeting agents, or TIGIT-targeting agents, Trop-2 targeting agents, FAP-directed therapies, 4-1BB (CD137)-directed therapies, or topoisomerase 1 inhibitors * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment * Eligibility only for the control arm * Prior allogeneic stem cell or solid organ transplantation * Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the initiation of study treatment * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled tumor-related pain * Uncontrolled or symptomatic hypercalcemia * Symptomatic, untreated, or actively progressing CNS metastases * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * History of malignancy other than UC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Significant cardiovascular disease * Uncontrolled hypertension * Grade 3 or greater hemorrhage or bleeding event within 28 days prior to initiation of study treatment * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Additional drug-specific exclusion criteria might apply Exclusion for MIBC Cohorts: * Prior treatment with systemic immunostimulatory agents prior to the initiation of study treatment * Eligibility only for the control arm * Prior allogeneic stem cell or solid organ transplantation * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment, with the following exceptions: Patients who received acute, low-dose, systemic immunosuppressant medications, or a one-time pulse dose of systemic immunosuppressant medication are eligible for the study after Medical Monitor approval has been obtained. Patients who received mineralocorticoids, corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. * Severe infection within 4 weeks prior to initiation of study treatment * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Also includes all the mUC exclusion criteria Additional Exclusion Criteria for Atezo+Tira and Atezo (Atezolizumab) +Tira+Cis (Cisplatin)+Gem (Gemcitabine) in the MIBC Cohorts: \- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening. Additional Exclusion Criteria for the Cisplatin-Eligible MIBC Cohort: * Patients who decline neoadjuvant cisplatin-based chemotherapy or in whom neoadjuvant cisplatin-based therapy is not appropriate. * Impaired renal function.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma transitional cell carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Bladder cancer Urothelial carcinoma

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Athens Medical Center

    Athens, 151 25, Greece

  • Attiko Hospital University of Athens

    Athens, 12462, Greece

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706, Spain

  • Hospital Clinic i Provincial

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Mara

    Madrid, 28009, Spain

  • Hospital Univ 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Institut Catala d Oncologia Hospitalet

    Barcelona, 08908, Spain

  • Institut Claudius Regaud

    Toulouse, 31052, France

  • Institut régional du Cancer Montpellier

    Montpellier, 34298, France

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Memorial Sloan-Kettering Cancer Center

    Commack, New York, 11725, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40241, United States

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 120-749, South Korea

  • Stanford Cancer Center

    Stanford, California, 94305-5820, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • UCLA Department of Medicine

    Los Angeles, California, 90024, United States

  • UCSF Comprehensive Cancer Ctr

    San Francisco, California, 94115, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-1716, United States

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536, United States

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

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