drugset / Trial / NCT01810016
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic Melanoma
Phase 1
Terminated
8 enrolled
Ludwig Institute for Cancer Research
Cancer Research Institute, NY, USA · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This was a Phase 1, open-label, non-randomized study of the combination of NY-ESO-1 plus ipilimumab in patients with unresectable or metastatic melanoma for whom treatment with ipilimumab was indicated. Patients must have had evidence of NY-ESO-1 or LAGE-1 tumor positivity and radiologically measurable disease by the immune-related Response Criteria (irRC). Primary study objectives were to determine the safety and tolerability of the combination and to evaluate humoral and cellular immune response. Secondary objectives were to evaluate tumor response and immunological changes in the tumor microenvironment.
Timeline
- Start
- 2014-01-24
- Primary completion
- 2016-05-17
- Completion
- 2016-05-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | NY-ESO-1 | Protein / enzyme biologic | 250 ug | Subcutaneous |
| Subject | NY-ESO-1 OLP4 | Vaccine | 1 mg | Subcutaneous |
| Background | Hiltonol | Other / unclassified | 1 mg | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | 1 ml | Subcutaneous |