Who is sponsoring NCT02452281?

NCT02452281 is sponsored by Rabih Said.

What drugs are being tested in NCT02452281?

Interventions: ipilimumab, HSPPC-96.

What is the status of NCT02452281?

NCT02452281 is currently WITHDRAWN.

Last reviewed 2016-01-22 · How we verify

Phase I-II Pilot Study to Evaluate the Immune-mediated Effects of an Autologous Tumor-derived Heat Shock Protein-peptide Complex 96 (HSPPC-96) Combined With Ipilimumab in Patients With Therapeutically Unresectable Stage III or Stage IV Malignant Melanoma

NCT02452281 Phase 1/Phase 2 WITHDRAWN

The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the cancer's "fingerprint." Injection of the vaccine may cause the patient's immune system to recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug approved by the FDA for the treatment of metastatic melanoma that boosts immune response.

Details

Lead sponsor	Rabih Said
Phase	Phase 1/Phase 2
Status	WITHDRAWN
Start date	2015-12
Completion	2018-12

Conditions

Melanoma

Interventions

ipilimumab
HSPPC-96

Primary outcomes

All enrolled patients who receive at least one dose of study drug (HSPPC-96) will be evaluated for safety. (adverse events) — 2 years
AEs will be coded by system organ class and preferred term using MedDRA. AEs will be summarized using descriptive statistics. Descriptive statistics will contain the number and percentage of patients who experience at least 1 AE, AEs related to study treatment, SAEs, SAEs related to study treatment, grade 3, 4 or 5 AEs, and grade 3, 4 or 5 AEs related to study treatment. In addition, the number and percentage of patients who discontinue treatment for any reason, including discontinuation due to an AE, will be provided together with the number and percentage of patients who die.
• To assess immunological response by surrogate markers of immune response and modulation of tumor cellular microenvironment — 2 years
All enrolled patients who receive at least one full cycle of treatment and have a baseline and at least one post treatment biological specimen available (tissue and/or blood) will be evaluated for immune response.

Countries

United States