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NCT05652673

Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial

Recruiting now NA Last updated 28 February 2025
What this trial tests

NA trial testing nivolumab in Melanoma Stage IV in 80 participants. Currently enrolling.

Timeline
1 February 2023
Primary endpoint
1 December 2025
1 December 2029

Quick facts

Lead sponsorErasmus Medical Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment80
Start date1 February 2023
Primary completion1 December 2025
Estimated completion1 December 2029
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. Waiting for ASCO to "Walk the Walk".
    Fojo T. · · 2023 · cited 1× · PMID 37774404 · DOI 10.1093/oncolo/oyad256
  7. 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
  8. 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:

Other trials of nivolumab

Trials testing the same drug.

Other recruiting trials for Melanoma Stage IV

Currently open trials in the same condition.

Other Erasmus Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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