Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- All enrolled patients who receive at least one dose of study drug (HSPPC-96) will be evaluated for safety. (adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Objective Response Rate (ORR) [ Time Frame: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months ] [ Designated as safety issue: No ]ORR defined by complete and partial responses.
- Progression Free Survival (PFS) [ Time Frame: tumor evaluations every 12 weeks or until the date of first documented progression or death, whichever came first, assessed up to 24 months ] [ Designated as safety issue: No ]Time to recurrence is time from surgery until recurrence or last tumor evaluation without recurrence.
|Study Start Date:||December 2015|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: ipilimumab + HSPPC-96
3 mg/kg, IV one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.
Other Name: Yervoy ®Drug: HSPPC-96
25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab; for at least 6 cycles of HSPPC-96 up to 12 doses.
Other Name: heat shock protein-peptide complex 96; Prophage; Vitespen
This is a randomized, open label, single-center, phase I-II trial to determine the safety, feasibility and immunogenicity of combination treatment of HSPPC-96 and ipilimumab in patients with therapeutically unresectable Stage III or Stage IV malignant melanoma.
The main purpose of this study is to assess whether the administration of the combination of ipilimumab and HSPPC-96 is safe. The rationale for combining the two treatments resides in their respective roles on the immune system as described below and based on the clinical experience collected so far. HSPPC-96 is able to initiate a tumor specific immune response that ipilimumab could theoretically amplify by blocking a checkpoint that naturally down-regulates T cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02452281
|United States, Texas|
|UTHealth Memorial Hermann Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rabih Said, MD, MPH||The University of Texas Health Science Center, Houston|