Clinical trial · Interventional
A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
NCT00289627CI-TRIAL-00024062completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab (MDX-010, BMS-734016) | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ipilimumab (MDX-010, BMS-734016)
- interventionNames
- Drug: ipilimumab (MDX-010, BMS-734016)
Primary outcomes (1)
- measure
- Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary outcomes (11)
- measure
- estimate disease control rate
- measure
- estimate progression free survival rate at Week 12
- measure
- estimate PFS
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously treated Stage III (unresectable)or Stage IV melanoma
References
Publications (2)
- DERIVEDSchadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9. PMID 25667295
- DERIVEDDi Giacomo AM, Danielli R, Guidoboni M, Calabro L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. doi: 10.1007/s00262-008-0642-y. Epub 2009 Jan 13. PMID 19139884