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NCT05652673
Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
NA trial testing nivolumab in Melanoma Stage IV in 80 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 February 2023 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2029 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- nivolumab (nivolumab) — full drug profile →
Conditions studied
- Melanoma Stage IV — all drugs for Melanoma Stage IV →
- Melanoma Stage III — all drugs for Melanoma Stage III →
- Immunotherapy — all drugs for Immunotherapy →
- Toxicity, Drug — all drugs for Toxicity, Drug →
Sponsor
Erasmus Medical Center
Who can join
18 and older, any sex, with Melanoma Stage IV or Melanoma Stage III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Features and Long-Term Outcomes of Stage IV Melanoma Patients Achieving Complete Response Under Anti-PD-1-Based Immunotherapy.
Chatziioannou E, Leiter U, Thomas I, Keim U, et al · · 2023 · cited 15× · PMID 37142875 · DOI 10.1007/s40257-023-00775-7 -
Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab - study protocol.
Janssen JC, van Dijk B, de Joode K, Aarts MJB, et al · · 2024 · cited 6× · PMID 38783238 · DOI 10.1186/s12885-024-12336-0 -
Survival after cessation of immunotherapies in melanoma: A systematic review and meta-analysis.
Mayer KE, Warburton L, Zaremba A, Preis S, et al · · 2025 · cited 4× · PMID 40181695 · DOI 10.1111/jdv.20672 -
Immune Checkpoint Inhibitors in Metastatic Bladder and Other Solid Malignancies: How Long is Enough?
Kumar V, Wei XX. · · 2023 · cited 3× · PMID 38993185 · DOI 10.3233/blc-230039 -
ICIs Exceptional Long Response in TNBC: Addressing the Issue of Optimal ICIs Duration. Two Cases and Review of the Literature.
Rota S, Sciortino C, Damian S, Duca M, et al · · 2025 · cited 1× · PMID 41200780 · DOI 10.1002/cnr2.70397 -
Waiting for ASCO to "Walk the Walk".
Fojo T. · · 2023 · cited 1× · PMID 37774404 · DOI 10.1093/oncolo/oyad256 -
Dose optimization of immune checkpoint inhibitors for gastrointestinal malignancies.
Alsina M, Beunza-Sola M, Fernández-Montes A, Padrón-Rodriguez B, et al · · 2026 · PMID 42180266 · DOI 10.1016/j.esmogo.2026.100338 -
Immunotherapy in Advanced Cutaneous Melanoma: From the Optimal Treatment Duration to the Impact on Survival in Case of Early Discontinuation Due to Immune-Related Adverse Events.
Triggiano G, Pezzicoli G, Tucci M. · · 2025 · PMID 40427544 · DOI 10.3390/biom15050651
Verify or expand the search:
- PubMed search for NCT05652673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Melanoma Stage IV
Currently open trials in the same condition.
- NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
- NCT06204991 — To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma · Phase 1 · recruiting
- NCT06444815 — A Study of VET3-TGI in Patients With Solid Tumors · Phase 1 · recruiting
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- NCT05655312 — MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma · Phase 1, PHASE2 · recruiting
Other Erasmus Medical Center trials
Trials by the same sponsor.
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- NCT07383194 — Prediction Models for LDLT Outcomes · not yet recruiting
- NCT07426575 — Evaluating the Usability of New Dialysis Bags · not yet recruiting
- NCT07329296 — The Regenerative Capacity of the Donor Liver After Living Donor Liver Transplantation: an Ambidirectional Cohort Study · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05652673 (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 Erasmus Medical Center
- Last refreshed: 28 February 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/NCT05652673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing