Last reviewed · How we verify
NCT03871036: ICRA
Improve Checkpoint-blockade Response in Advanced Urothelial Cancer
Phase 1, PHASE2 trial testing Tremelimumab in Urothelial Carcinoma in 53 participants. Completed in 15 January 2025.
7 September 2023
Quick facts
| Lead sponsor | The Netherlands Cancer Institute |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 1 May 2019 |
| Primary completion | 7 September 2023 |
| Estimated completion | 15 January 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Tremelimumab (TREMELIMUMAB) — full drug profile →
- Durvalumab — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
Sponsor
The Netherlands Cancer Institute
Who can join
18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial will include metastatic urothelial carcinoma patients who progressed during or after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing regimen, or are cisplatin-ineligible. Patients will receive either paclitaxel in combination with durvalumab (anti-PDL-1) and a single dose (300 mg) of tremelimumab (anti-CTLA4), or paclitaxel with only a high dose of tremelimumab (750 mg). Tremelimumab (750 mg), without paclitaxel will be used as a comparison arm. A run-in safety phase will be followed by a non-comparative 3-arm randomized study with a Simon's 2-stage optimal design.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Adverse Effects and Toxicity of Immune Checkpoint Inhibitors For Patients With Urothelial Carcinoma.
Wang D, Sun K, Wang T, Zhang D, et al · · 2021 · cited 8× · PMID 34867321 · DOI 10.3389/fphar.2021.710943 -
Immune Checkpoint Inhibitors in the Management of Urothelial Carcinoma.
Patel A, Bisno DI, Patel HV, Ghodoussipour S, et al · · 2021 · cited 4× · PMID 34263255 · DOI 10.33696/cancerimmunol.3.047
Verify or expand the search:
- PubMed search for NCT03871036
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tremelimumab
Trials testing the same drug.
- NCT07288034 — Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatmen · Phase 2 · recruiting
- NCT07511504 — Y-90 Radioembolization, Durvalumab, Tremelimumab, and Zanzalintinib for the Treatment of Unresectable and Locally-Advanc · Phase 2 · not yet recruiting
- NCT07391670 — A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durval · Phase 1 · recruiting
- NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
- NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer · Phase 2 · recruiting
Other recruiting trials for Urothelial Carcinoma
Currently open trials in the same condition.
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
- NCT07421700 — Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer · Phase 1, PHASE2 · recruiting
- NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
- NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting
Other The Netherlands Cancer Institute trials
Trials by the same sponsor.
- NCT07436858 — Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER · Phase 1 · not yet recruiting
- NCT07071727 — Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas · NA · recruiting
- NCT06931769 — TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer · recruiting
- NCT06273800 — Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients · NA · recruiting
- NCT07310758 — Contrast-enhanced Ultrasound for Sentinel Node Detection · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03871036 (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 The Netherlands Cancer Institute
- Last refreshed: 6 March 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/NCT03871036.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing