High-Dose Aldesleukin and Ipilimumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery

NCT02203604 ↗

Phase 2 Terminated 9 enrolled CINJRegulatory National Cancer Institute (NCI) · collab Rutgers Cancer Institute of New Jersey · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies, such as aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with ipilimumab may work better in treating patients with melanoma.

Timeline

Start: 2014-11-26
Primary completion: 2020-01-27
Completion: 2020-01-27

Outcome

Outcome not reported

Stopped (Enrollment): “Insufficient rate of accrual”

Publications

Silk AW, Kaufman HL, Curti B, Mehnert JM, Margolin K, McDermott D, Clark J, Newman J, Bommareddy PK, Denzin L, Najmi S, Haider A, Shih W, Kane MP, Zloza A. High-Dose Ipilimumab and High-Dose Interleukin-2 for Patients With Advanced Melanoma. Front Oncol. 2020 Jan 10;9:1483. doi: 10.3389/fonc.2019.01483. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	aldesleukin	Protein / enzyme biologic	600000 iu/kg	Intravenous