Who is sponsoring NCT03935347?

NCT03935347 is sponsored by Roswell Park Cancer Institute.

What drugs are being tested in NCT03935347?

Interventions in NCT03935347: Cyclophosphamide, Fludarabine, Fludarabine Phosphate, Pembrolizumab, Autologous Tumor Infiltrating Lymphocytes LN-145, Aldesleukin.

What condition does NCT03935347 study?

NCT03935347 studies Metastatic Bladder Urothelial Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Unresectable Renal Pelvis Urothelial Carcinoma, Unresectable Ureter Urothelial Carcinoma.

Is NCT03935347 still recruiting?

NCT03935347 is currently withdrawn. Last updated 2 January 2020.

Last reviewed 2020-01-02 · How we verify

NCT03935347

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

Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy

Withdrawn Phase 2 Last updated 2 January 2020

What this trial tests

Phase 2 trial testing Cyclophosphamide in Metastatic Bladder Urothelial Carcinoma. Withdrawn.

Timeline

20 June 2019

Primary endpoint
1 May 2022

1 May 2023

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	20 June 2019
Primary completion	1 May 2022
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →
Autologous Tumor Infiltrating Lymphocytes LN-145
Aldesleukin (ALDESLEUKIN) — full drug profile →

Conditions studied

Metastatic Bladder Urothelial Carcinoma — all drugs for Metastatic Bladder Urothelial Carcinoma →
Metastatic Renal Pelvis Urothelial Carcinoma — all drugs for Metastatic Renal Pelvis Urothelial Carcinoma →
Metastatic Ureter Urothelial Carcinoma — all drugs for Metastatic Ureter Urothelial Carcinoma →
Metastatic Urethral Urothelial Carcinoma — all drugs for Metastatic Urethral Urothelial Carcinoma →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Metastatic Bladder Urothelial Carcinoma or Metastatic Renal Pelvis Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well autologous tumor infiltrating lymphocytes (LN-145) and pembrolizumab work in treating patients with transitional cell cancer that cannot be removed by surgery or has spread to other places in the body and have failed cisplatin-based chemotherapy. LN-145 is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving LN-145 may help control transitional cell bladder cancer when given together with pembrolizumab

Publications & conference data

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

New emerging targets in cancer immunotherapy: the role of neoantigens.
De Mattos-Arruda L, Blanco-Heredia J, Aguilar-Gurrieri C, Carrillo J, et al · · 2020 · cited 23× · PMID 32269031 · DOI 10.1136/esmoopen-2020-000684
A Comprehensive Review of Immunotherapy Clinical Trials for Metastatic Urothelial Carcinoma: Immune Checkpoint Inhibitors Alone or in Combination, Novel Antibodies, Cellular Therapies, and Vaccines.
Patel DM, Mateen R, Qaddour N, Carrillo A, et al · · 2024 · cited 13× · PMID 38254823 · DOI 10.3390/cancers16020335

Verify or expand the search:

Other trials of Cyclophosphamide

Trials testing the same drug.

NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07509008 — Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Manageme · Phase 1, PHASE2 · not yet recruiting
NCT07444632 — Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/ · Phase 1 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Metastatic Bladder Urothelial Carcinoma

Currently open trials in the same condition.

NCT07087860 — Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers · Phase 2 · recruiting
NCT06764095 — Enfortumab Vedotin and Pembrolizumab With Cystectomy and/or Ureterectomy for Locally Advanced or Metastatic Bladder and · Phase 4 · recruiting
NCT06630416 — Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothe · Phase 2 · recruiting
NCT04963153 — Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy an · Phase 1 · active not recruiting
NCT05092958 — Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients · Phase 3 · active not recruiting

Other Roswell Park Cancer Institute trials

Trials by the same sponsor.

NCT07489287 — GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer · Phase 1 · not yet recruiting
NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids · Phase 2 · not yet recruiting
NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I · Phase 2 · not yet recruiting
NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream · EARLY_PHASE1 · not yet recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn

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 NCT03935347 (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 Roswell Park Cancer Institute
Last refreshed: 2 January 2020

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/NCT03935347.

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