Immunotherapy duo takes on advanced bladder cancer in global trial

NCT ID NCT02516241

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tested whether two immunotherapy drugs (durvalumab and tremelimumab) work better than standard chemotherapy for people with advanced bladder cancer that has spread (stage IV). Over 1,100 participants received either the drug combination, durvalumab alone, or chemo. The main goal was to see if the immunotherapies helped people live longer. This is not a cure, but aims to control the disease and extend survival.

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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

1,126 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Dec 2026

An estimate. End dates often move.

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 to 130 years

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: * Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy. * Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) \<60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss • CTCAE Grade ≥2 peripheral neuropathy • New York Heart Association ≥Class III heart failure. * Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization. Exclusion Criteria: * Prior exposure to immune-mediated therapy, including but not limited to, other anti cytotoxic T-lymphocyte-associated protein 4 (CTLA 4), anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment. * History of allogenic organ transplantation that requires use of immunosuppressive agents. * Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca. * Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI (preferred)/CT, preferably with IV contrast to access baseline disease status. * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). * Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.

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Conditions

The condition(s) this trial relates to.

bladder transitional cell carcinoma stage IVb bladder cancer urothelial carcinoma

As listed by the trial registrant

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

Urothelial cancer

Contacts and locations

Locations

Research Site

Los Angeles, California, 90095, United States
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Stanford, California, 94305, United States
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Aurora, Colorado, 80045, United States
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New Haven, Connecticut, 06520, United States
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Tampa, Florida, 33612, United States
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Atlanta, Georgia, 30322, United States
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Louisville, Kentucky, 40202, United States
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Boston, Massachusetts, 02215, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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Omaha, Nebraska, 68130, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Seattle, Washington, 98101, United States
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Box Hill, 3128, Australia
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Elizabeth Vale, 5112, Australia
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Macquarie University, 2109, Australia
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St Leonards, 2065, Australia
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Waratah, 2298, Australia
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Vienna, 1140, Austria
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Brussels, 1000, Belgium
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Brussels, 1200, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30380-472, Brazil
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Ijuí, 98700-000, Brazil
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Itajaí, 88301-220, Brazil
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Porto Alegre, 90035-003, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Rio de Janeiro, 22793-080, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01209-000, Brazil
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São Paulo, 01321-001, Brazil
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São Paulo, 01509-900, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, K1H 1C4, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Québec, Quebec, G1R 3S1, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Beijing, 100034, China
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Beijing, 100039, China
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Beijing, 100191, China
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Changchun, 130012, China
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Changsha, 410013, China
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Chongqing, 400038, China
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Hangzhou, 310009, China
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Hangzhou, 310014, China
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Nanjing, 210008, China
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Shanghai, 200000, China
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Shanghai, 200032, China
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Shanghai, 200072, China
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Shanghai, 200080, China
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Shanghai, 200127, China
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Shenyang, 110001, China
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Tianjin, 300211, China
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Xi'an, 710061, China
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Xiamen, 361003, China
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Århus C, 8000, Denmark
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Herlev, 2730, Denmark
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København Ø, 2100, Denmark
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Odense C, 5000, Denmark
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Bordeaux, 33000, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Lyon, 69008, France
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Marseille, 13273, France
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Paris, 75475, France
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Poitiers, 86021, France
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Suresnes, 92151, France
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Toulouse, 31059, France
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Villejuif, 94805, France
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Jena, 07747, Germany
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München, 81675, Germany
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Münster, 48149, Germany
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Athens, 11528, Greece
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Athens, 14564, Greece
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Heraklion, 71110, Greece
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Holargos, Athens, 155 62, Greece
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Maroussi, Athens, 15125, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56 429, Greece
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 5265601, Israel
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Ẕerifin, 70300, Israel
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Arezzo, 52100, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Orbassano, 10043, Italy
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Pavia, 27100, Italy
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Roma, 00152, Italy
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San Giovanni Rotondo, 71013, Italy
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Akita, 010-8543, Japan
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Bunkyō City, 113-8603, Japan
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Fukuoka, 811-1347, Japan
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Hakata-shi, 812-0033, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 730-8518, Japan
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Izumo-shi, 693-8501, Japan
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Kagoshima, 890-8520, Japan
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Kanazawa, 920-8641, Japan
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Kita-gun, 761-0793, Japan
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Kobe, 650-0047, Japan
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Koshigaya-shi, 343-8555, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-0008, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Morioka, 028-3695, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 460-0001, Japan
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Nagoya, 466-8560, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Saga, 840-8571, Japan
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Sagamihara-shi, 252-0315, Japan
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Sakura-shi, 285-8741, Japan
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Sapporo, 060-8648, Japan
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Suita-shi, 565-0871, Japan
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Takatsuki-shi, 569-8686, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 236-0004, Japan
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Guadalajara, 44280, Mexico
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León, 37000, Mexico
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Mexico City, 01120, Mexico
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México, 04739, Mexico
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México, 06760, Mexico
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Monterrey, 64460, Mexico
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Breda, 4819 EV, Netherlands
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Enschede, 7512 KZ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Leiden, 2333 ZA, Netherlands
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Maastricht, 6229 HX, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Gdansk, 80-462, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Gliwice, 44-101, Poland
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Olsztyn, 10-228, Poland
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Otwock, 05-400, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-781, Poland
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Lisbon, 1649-035, Portugal
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Loures, 2674-514, Portugal
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Porto, 4099-001, Portugal
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Moscow, 105229, Russia
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Moscow, 115478, Russia
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Murmansk, 183047, Russia
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Nizhnyi Novgorod, 603001, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 191015, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 199178, Russia
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Ufa, 450054, Russia
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Yaroslavl, 150054, Russia
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Badajoz, 06008, Spain
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Badalona, 08916, Spain
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Barcelona, 08003, Spain
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Barcelona, 08243, Spain
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Elche(Alicante), 03202, Spain
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Madrid, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Pozuelo de Alarcón, 28223, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Kaohsiung City, Taiwan
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Taichung, 00407, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan City, 333, Taiwan
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Ankara, 06230, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, E1 1BB, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Southampton, SO16 6YD, United Kingdom

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