Who is sponsoring NCT03609216?

NCT03609216 is sponsored by Alliance for Clinical Trials in Oncology.

What drugs are being tested in NCT03609216?

Interventions in NCT03609216: Gemcitabine Hydrochloride, Cisplatin, Pegfilgrastim, Conventional Surgery, Radical Cystectomy, Chemoradiotherapy.

What condition does NCT03609216 study?

NCT03609216 studies Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma.

Is NCT03609216 still recruiting?

NCT03609216 is currently active, enrolled. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT03609216

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

Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Gemcitabine Hydrochloride in Infiltrating Bladder Urothelial Carcinoma in 237 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 December 2018

Primary endpoint
1 February 2027

1 February 2029

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	237
Start date	10 December 2018
Primary completion	1 February 2027
Estimated completion	1 February 2029
Sites	424 locations across United States

Drugs / interventions tested

Gemcitabine Hydrochloride — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Pegfilgrastim (PEGFILGRASTIM) — full drug profile →
Conventional Surgery
Radical Cystectomy
Chemoradiotherapy

Conditions studied

Infiltrating Bladder Urothelial Carcinoma — all drugs for Infiltrating Bladder Urothelial Carcinoma →
Stage II Bladder Urothelial Carcinoma — all drugs for Stage II Bladder Urothelial Carcinoma →
Stage III Bladder Urothelial Carcinoma — all drugs for Stage III Bladder Urothelial Carcinoma →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

18 and older, any sex, with Infiltrating Bladder Urothelial Carcinoma or Stage II Bladder Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Publications & conference data

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

Molecular correlates of cisplatin-based chemotherapy response in muscle invasive bladder cancer by integrated multi-omics analysis.
Taber A, Christensen E, Lamy P, Nordentoft I, et al · · 2020 · cited 158× · PMID 32978382 · DOI 10.1038/s41467-020-18640-0
Phase II Study of Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer.
Rose TL, Harrison MR, Deal AM, Ramalingam S, et al · · 2021 · cited 114× · PMID 34428076 · DOI 10.1200/jco.21.01003
Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.
Galsky MD, Daneshmand S, Izadmehr S, Gonzalez-Kozlova E, et al · · 2023 · cited 104× · PMID 37783966 · DOI 10.1038/s41591-023-02568-1
Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial.
Funt SA, Lattanzi M, Whiting K, Al-Ahmadie H, et al · · 2022 · cited 83× · PMID 35089812 · DOI 10.1200/jco.21.01485
Urine tumor DNA detection of minimal residual disease in muscle-invasive bladder cancer treated with curative-intent radical cystectomy: A cohort study.
Chauhan PS, Chen K, Babbra RK, Feng W, et al · · 2021 · cited 58× · PMID 34464379 · DOI 10.1371/journal.pmed.1003732
Cell-Free Urine and Plasma DNA Mutational Analysis Predicts Neoadjuvant Chemotherapy Response and Outcome in Patients with Muscle-Invasive Bladder Cancer.
Christensen E, Nordentoft I, Birkenkamp-Demtröder K, Elbæk SK, et al · · 2023 · cited 51× · PMID 36780195 · DOI 10.1158/1078-0432.ccr-22-3250
Patients with Muscle-Invasive Bladder Cancer with Nonluminal Subtype Derive Greatest Benefit from Platinum Based Neoadjuvant Chemotherapy.
Lotan Y, de Jong JJ, Liu VYT, Bismar TA, et al · · 2022 · cited 49× · PMID 34643090 · DOI 10.1097/ju.0000000000002261
Phase II Trial of Risk-Enabled Therapy After Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer (RETAIN 1).
Geynisman DM, Abbosh PH, Ross E, Zibelman MR, et al · · 2025 · cited 34× · PMID 39680823 · DOI 10.1200/jco-24-01214

Verify or expand the search:

Other trials of Gemcitabine Hydrochloride

Trials testing the same drug.

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NCT05514912 — Preoperative Nab-paclitaxel, Cisplatin, and Gemcitabine Chemotherapy With or Without Infigratinib Targeted Therapy for t · Phase 2 · withdrawn
NCT05685602 — CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer · Phase 1 · recruiting
NCT05733000 — CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With · Phase 2 · recruiting
NCT05211323 — A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in · Phase 2 · active not recruiting

Other Alliance for Clinical Trials in Oncology trials

Trials by the same sponsor.

NCT07293247 — A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After · Phase 2 · not yet recruiting
NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
NCT07059884 — Distance-Based Exercise to Preserve Function and Prevent Disability · NA · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07091617 — Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer · NA · 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 NCT03609216 (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 Alliance for Clinical Trials in Oncology
Last refreshed: 13 April 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/NCT03609216.

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