New immunotherapy cocktail aims to fight advanced bladder cancer

NCT ID NCT03682068

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This large Phase 3 trial is testing whether adding the immunotherapy drugs durvalumab (with or without tremelimumab) to standard chemotherapy can help people with advanced bladder cancer that cannot be removed by surgery. Over 1,200 participants worldwide are receiving either chemo alone or chemo plus one of the immunotherapy combinations. The main goal is to see if the combinations help people live longer.

What this could mean

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

Active substance: durvalumab and tremelimumab (immunotherapy drugs) plus chemotherapy (cisplatin or carboplatin with gemcitabine)
What this could lead to: If successful, this could offer a new first-line treatment option that helps people with advanced bladder cancer live longer.
What could go wrong: This is an early-stage study; results may not show a clear benefit over standard chemo alone. Immunotherapy can cause serious immune-related side effects.

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

1,246 people

The number who actually took part.

Started

Sep 2018

Expected to finish

Jun 2027

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.

Key Inclusion Criteria: * Patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma (transitional cell and mixed transitional/non-transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) * Patients who have not been previously treated with first-line chemotherapy. Patients who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment for locally advanced disease are eligible provided that progression to locally advanced or metastatic disease has occurred \>12 months from the last therapy \[for chemoradiation and adjuvant treatment\] or \>12 months from the last surgery \[for neoadjuvant treatment\]. * At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion at baseline. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment * Adequate organ and marrow function as defined in the protocol * Life expectancy ≥12 weeks in the opinion of the investigator * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Key Exclusion Criteria: * Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least 28 days prior to the initiation of study treatment. * No severe concomitant condition that requires immunosuppression medication * Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Patients who may be eligible for or are being considered for radical resection during the course of the study. * Any medical contraindications to platinum (cisplatin or carboplatin) based doublet chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Metastatic urothelial cancer Unresectable locally advanced urothelial cancer

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35294, United States
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Bakersfield, California, 93309, United States
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Fullerton, California, 92835, United States
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Los Angeles, California, 90024, United States
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Salinas, California, 93901, United States
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Santa Barbara, California, 93105, United States
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Truckee, California, 96161, United States
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New Haven, Connecticut, 06520, United States
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Washington D.C., District of Columbia, 20007, United States
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Orlando, Florida, 32806, United States
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Chicago, Illinois, 60611, United States
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Fort Wayne, Indiana, 46804, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70112, United States
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Grand Rapids, Michigan, 49503, United States
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Bozeman, Montana, 59715, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10029, United States
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New York, New York, 10065, United States
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Rochester, New York, 14642, United States
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Germantown, Tennessee, 38138, United States
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Fort Worth, Texas, 76104, United States
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Ciudad de Buenos Aires, 1280, Argentina
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Ciudad de Buenos Aires, C1120AAT, Argentina
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Ciudad de Buenos Aires, C1419AHL, Argentina
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Ciudad de Buenos Aires, C1426ANZ, Argentina
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Rosario, S2000DEJ, Argentina
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Box Hill, 3128, Australia
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Elizabeth Vale, 5112, Australia
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Kogarah, 2217, Australia
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Macquarie University, 2109, Australia
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Murdoch, 6150, Australia
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Orange, 2800, Australia
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South Brisbane, 4101, Australia
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St Albans, 3021, Australia
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Curitiba, 80810-050, Brazil
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Fortaleza, 60336-232, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14048-900, 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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Salvador, 41.950-610, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1797, Bulgaria
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Varna, 9010, Bulgaria
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Calgary, Alberta, T2N 5G2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G IX6, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100034, China
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Beijing, 100191, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chongqing, 400038, China
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Chongqing, 400042, China
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Dalian, 116027, China
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Guangzhou, 510000, China
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Guangzhou, 510060, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Hangzhou, 310014, China
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Hangzhou, 310022, China
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Jinan, 250012, China
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Nanchang, 330006, China
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Nanjing, 2100008, China
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Shanghai, 200032, China
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Shanghai, 200072, China
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Shenyang, 110001, China
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Suzhou, 215006, China
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Tianjin, 300211, China
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Tianjin, China
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Ürümqi, 830000, China
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Wuhan, 430022, China
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Xi'an, 710061, China
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Brno, 656 91, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Ostrava, 708 52, Czechia
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Prague, 128 08, Czechia
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Prague, 140 59, Czechia
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Prague, 180 81, Czechia
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Budapest, 1062, Hungary
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Budapest, 1122, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Kecskemét, 6000, Hungary
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Szolnok, 5000, Hungary
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Gurgaon, 122001, India
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Hubli, 580025, India
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Kolkata, 700160, India
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Mysuru, 570017, India
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Nagpur, 440012, India
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Nashik, 422005, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Pune, 411004, India
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Arezzo, 52100, 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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Parma, 43126, Italy
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Pavia, 27100, Italy
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Roma, 00100, Italy
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Terni, 05100, Italy
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Verona, 37134, Italy
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1347, Japan
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Hirosaki-shi, 036-8563, Japan
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Kanazawa, 920-8641, Japan
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Kita-gun, 761-0793, 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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Kumamoto, 860-8556, Japan
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Kyoto, 606-8507, Japan
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Miyazaki, 889-1692, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 467-0001, Japan
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Niigata, 951-8520, 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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Shinjuku-ku, 160-8582, Japan
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Suita-shi, 565-0871, Japan
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Toyama, 930-0194, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Bacolod, 6100, Philippines
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Baguio City, 2600, Philippines
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Cebu, 6000, Philippines
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Davao City, 8000, Philippines
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Makati, 1229, Philippines
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Manila, 1015, Philippines
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Quezon City, 1101, Philippines
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Quezon City, 1104, Philippines
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Bialystok, 15-027, Poland
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Gdansk, 80-952, Poland
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Grudziądz, 86-300, Poland
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Koszalin, 75-581, Poland
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Krakow, 31-501, Poland
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Olsztyn, 10-228, Poland
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Poznan, 60-693, Poland
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Radom, 26-600, Poland
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Warsaw, 02-781, Poland
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Ivanovo, 153040, Russia
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Krasnoyarsk, 660133, Russia
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Moscow, 105077, Russia
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Moscow, 105229, Russia
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Moscow, 115280, Russia
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Moscow, 125284, Russia
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Nizhny Novgorod, 603074, Russia
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Nizhny Novgorod, 603137, Russia
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Omsk, 644013, Russia
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Rostov-on-Don, 344037, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197758, Russia
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Saint Petersburg, 199178, Russia
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Tyumen, 625041, Russia
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Vologda, 160012, Russia
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Goyang-si, 10408, South Korea
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Incheon, 21565, South Korea
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Seoul, 02841, 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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Suwon, 16247, South Korea
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Barcelona, 08908, Spain
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Lugo, 27003, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10050, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10400, Thailand
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Khon Kaen, 40002, Thailand
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Mueang, 50200, Thailand
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Songkhla, 90110, Thailand
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Adana, 1260, Turkey (Türkiye)
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Adapazarı, 54290, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam

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