NCT03682068 (NILE) is a Phase 3 clinical trial of Durvalumab in Unresectable Locally Advanced Urothelial Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT03682068?

NCT03682068 is sponsored by AstraZeneca.

What drugs are being tested in NCT03682068?

Interventions in NCT03682068: Durvalumab, Tremelimumab, Cisplatin + Gemcitabine, Carboplatin + Gemcitabine.

What condition does NCT03682068 study?

NCT03682068 studies Unresectable Locally Advanced Urothelial Cancer, Metastatic Urothelial Cancer.

Is NCT03682068 still recruiting?

NCT03682068 is currently active, enrolled. Last updated 3 February 2026.

Last reviewed 2026-02-03 · How we verify

NCT03682068: NILE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

Active, enrolled Phase 3 Last updated 3 February 2026

What this trial tests

Phase 3 trial testing Durvalumab in Unresectable Locally Advanced Urothelial Cancer in 1,246 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 September 2018

Primary endpoint
29 April 2026

29 April 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,246
Start date	27 September 2018
Primary completion	29 April 2026
Estimated completion	29 April 2026
Sites	222 locations across Italy, Japan, Taiwan, Vietnam, Poland, South Korea, Philippines, Russia

Drugs / interventions tested

Durvalumab — full drug profile →
Tremelimumab (TREMELIMUMAB) — full drug profile →
Cisplatin + Gemcitabine — full drug profile →
Carboplatin + Gemcitabine — full drug profile →

Conditions studied

Unresectable Locally Advanced Urothelial Cancer — all drugs for Unresectable Locally Advanced Urothelial Cancer →
Metastatic Urothelial Cancer — all drugs for Metastatic Urothelial Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Unresectable Locally Advanced Urothelial Cancer or Metastatic Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Antibodies to watch in 2023.
Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
Blockade of novel immune checkpoints and new therapeutic combinations to boost antitumor immunity.
Archilla-Ortega A, Domuro C, Martin-Liberal J, Muñoz P. · · 2022 · cited 61× · PMID 35164813 · DOI 10.1186/s13046-022-02264-x
Immune Checkpoint Inhibitors in Urothelial Bladder Cancer: State of the Art and Future Perspectives.
Roviello G, Catalano M, Santi R, Palmieri VE, et al · · 2021 · cited 44× · PMID 34503220 · DOI 10.3390/cancers13174411
Metastatic Urothelial Cancer: a rapidly changing treatment landscape.
Stecca C, Abdeljalil O, Sridhar SS. · · 2021 · cited 40× · PMID 34616491 · DOI 10.1177/17588359211047352
Current Status and Future Perspectives of Immunotherapy for Locally Advanced or Metastatic Urothelial Carcinoma: A Comprehensive Review.
Kim TJ, Cho KS, Koo KC. · · 2020 · cited 27× · PMID 31940998 · DOI 10.3390/cancers12010192

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03682068 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 3 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03682068.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing