NCT04863885 is a Phase 1/Phase 2 clinical trial of Ipilimumab in Metastatic Urothelial Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT04863885?

NCT04863885 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT04863885?

Interventions in NCT04863885: Ipilimumab, Nivolumab, Sacituzumab govitecan.

What condition does NCT04863885 study?

NCT04863885 studies Metastatic Urothelial Carcinoma.

Is NCT04863885 still recruiting?

NCT04863885 is currently active, enrolled. Last updated 11 December 2025.

Last reviewed 2025-12-11 · How we verify

NCT04863885

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

Phase I/II Study of Ipilimumab Plus Nivolumab (IPI-NIVO) Combined With Sacituzumab Govitecan (SG)as First-line Treatment for Cisplatin-ineligible Metastatic Urothelial Carcinoma

Active, enrolled Phase 1/Phase 2 Last updated 11 December 2025

What this trial tests

Phase 1/Phase 2 trial testing Ipilimumab in Metastatic Urothelial Carcinoma in 46 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 April 2021

Primary endpoint
12 September 2025

1 October 2027

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	30 April 2021
Primary completion	12 September 2025
Estimated completion	1 October 2027
Sites	1 location across United States

Drugs / interventions tested

Ipilimumab — full drug profile →
Nivolumab (nivolumab) — full drug profile →
Sacituzumab govitecan — full drug profile →

Conditions studied

Metastatic Urothelial Carcinoma — all drugs for Metastatic Urothelial Carcinoma →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Phase 1: Maximum Tolerated Dose
Time frame: Up to 12 months
Determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 dose (RP2D) of Sacituzumab Govitecan when combined with Ipilimumab and Nivolumab
Phase 2: Overall Response Rate
Time frame: Up to 30 months
Overall Response Rate (ORR) of Sacituzumab Govitecan with Ipilimumab and Nivolumab combination. ORR is defined as the rate of the best overall response as complete response (CR) or partial response (CR). OR will be summarized by the percentage of responses with a 95% confidence interval as calculated from Clopper-Pearson method.

Sponsor's own description

The purpose of this study is to see how well the study drugs called Ipilimumab plus Nivolumab (IPI-NIVO) work when added to another study drug called Sacituzumab Govitecan for people who have metastatic bladder cancer.

Publications & conference data

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

The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
Mechanisms of Resistance to Antibody-Drug Conjugates.
Khoury R, Saleh K, Khalife N, Saleh M, et al · · 2023 · cited 100× · PMID 37298631 · DOI 10.3390/ijms24119674
Overview of Trop-2 in Cancer: From Pre-Clinical Studies to Future Directions in Clinical Settings.
Lombardi P, Filetti M, Falcone R, Altamura V, et al · · 2023 · cited 41× · PMID 36980630 · DOI 10.3390/cancers15061744
The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies.
Yu P, Zhu C, You X, Gu W, et al · · 2024 · cited 28× · PMID 38898003 · DOI 10.1038/s41419-024-06837-w
Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8
A New Kid on the Block: Sacituzumab Govitecan for the Treatment of Breast Cancer and Other Solid Tumors.
Pavone G, Motta L, Martorana F, Motta G, et al · · 2021 · cited 27× · PMID 34885875 · DOI 10.3390/molecules26237294
Immune-Checkpoint Inhibitors in Advanced Bladder Cancer: Seize the Day.
Maiorano BA, De Giorgi U, Ciardiello D, Schinzari G, et al · · 2022 · cited 19× · PMID 35203620 · DOI 10.3390/biomedicines10020411
Revisiting Treatment of Metastatic Urothelial Cancer: Where Do Cisplatin and Platinum Ineligibility Criteria Stand?
Moussa MJ, Campbell MT, Alhalabi O. · · 2024 · cited 16× · PMID 38540132 · DOI 10.3390/biomedicines12030519

Verify or expand the search:

Other trials of Ipilimumab

Trials testing the same drug.

NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz · Phase 1, PHASE2 · recruiting
NCT07128680 — Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Met · Phase 1 · recruiting

Other recruiting trials for Metastatic Urothelial Carcinoma

Currently open trials in the same condition.

NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
NCT07221942 — Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma · Phase 2 · recruiting
NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting
NCT06524544 — A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of · Phase 3 · recruiting
NCT06862219 — A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer · Phase 4 · recruiting

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

NCT05041335 — Wet Heparinized Suction for Abdominal Cancer · NA · not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · 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 NCT04863885 (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 H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 11 December 2025

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/NCT04863885.

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