NCT03728465 is a Phase 2 clinical trial of Nivolumab in Metastatic Melanoma, sponsored by University Hospital Tuebingen.

Who is sponsoring NCT03728465?

NCT03728465 is sponsored by University Hospital Tuebingen.

What drugs are being tested in NCT03728465?

Interventions in NCT03728465: Nivolumab, Ipilimumab.

What condition does NCT03728465 study?

NCT03728465 studies Metastatic Melanoma, Brain Metastases.

Is NCT03728465 still recruiting?

NCT03728465 is currently terminated. Last updated 3 February 2021.

Last reviewed 2021-02-03 · How we verify

NCT03728465

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

Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma

Terminated Phase 2 Last updated 3 February 2021

What this trial tests

Phase 2 trial testing Nivolumab in Metastatic Melanoma in 6 participants. Terminated before completion.

Timeline

10 April 2018

Primary endpoint
1 January 2021

1 January 2021

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	10 April 2018
Primary completion	1 January 2021
Estimated completion	1 January 2021
Sites	11 locations across Germany

Drugs / interventions tested

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

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →
Brain Metastases — all drugs for Brain Metastases →

Sponsor

University Hospital Tuebingen

Who can join

18 and older, any sex, with Metastatic Melanoma or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Up to 50% of patients with unresectable metastatic melanoma will develop brain metastases during their lifetime. A possible treatment options for patients with brain metastases are surgery and radiotherapy but usually for lesions in the range of \< 3 brain metastases. This study was performed to evaluate the addition of immune checkpoint inhibitors in patients with stage IV melanoma with \> 3 symptomatic brain metastases, who are not eligible for surgery or radiosurgery.

Publications & conference data

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

Immunotherapy of brain metastases: breaking a "dogma".
Di Giacomo AM, Valente M, Cerase A, Lofiego MF, et al · · 2019 · cited 69× · PMID 31623643 · DOI 10.1186/s13046-019-1426-2
Emerging principles of brain immunology and immune checkpoint blockade in brain metastases.
Fares J, Ulasov I, Timashev P, Lesniak MS. · · 2021 · cited 40× · PMID 33893488 · DOI 10.1093/brain/awab012
Immune Checkpoint Inhibitors for Brain Metastases: A Primer for Neurosurgeons.
Aquilanti E, Brastianos PK. · · 2020 · cited 25× · PMID 32302389 · DOI 10.1093/neuros/nyaa095
Next-generation immunotherapies for brain metastatic cancers.
López Vázquez M, Du W, Kanaya N, Kitamura Y, et al · · 2021 · cited 8× · PMID 33722479 · DOI 10.1016/j.trecan.2021.02.003
Melanoma brain metastases: review of histopathological features and immune-molecular aspects.
Salvati L, Mandalà M, Massi D. · · 2020 · cited 6× · PMID 32821376 · DOI 10.2217/mmt-2019-0021
Intracranial Treatment in Melanoma Patients with Brain Metastasis Is Associated with Improved Survival in the Era of Immunotherapy and Anti-BRAF Therapy.
Dalmasso C, Pagès C, Chaltiel L, Sibaud V, et al · · 2021 · cited 3× · PMID 34503304 · DOI 10.3390/cancers13174493

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
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
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · 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

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting

Other University Hospital Tuebingen trials

Trials by the same sponsor.

NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
NCT07276503 — Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperati · not yet recruiting
NCT07411365 — Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI · NA · not yet recruiting
NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07378891 — Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI) · enrolling by invitation

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 NCT03728465 (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 University Hospital Tuebingen
Last refreshed: 3 February 2021

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/NCT03728465.

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