A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Combination Treatment With HF10, a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Patients With Stage IIIB, Stage IIIC, or Stage IV Unresectable or Metastatic Malignant Melanoma|
- Best overall response rate (BORR) [ Time Frame: at 24 weeks ]
- Adverse Event Summaries, Vital Signs, and Laboratory Parameters as a Measure of Safety and Tolerability [ Time Frame: until Week 24 ]Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
- Objective response rate (ORR) [ Time Frame: at Weeks 12, 18, and 24 ]
- Progression-free survival (PFS) [ Time Frame: for 1 year ]
- Durable response rate (DRR) [ Time Frame: for 1 year ]
- 1-year survival rate [ Time Frame: at 1 year ]
- Accumulation of Lymphocytes in the Tumor by using Core Biopsy Samples [ Time Frame: pre-treatment screening and Week 24 ]
- Change in Cytokine Profiles by using Peripheral Blood Samples [ Time Frame: pre-treatment screening and Week 24 ]
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||March 2017|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
|Experimental: HF10 plus ipilimumab||
Biological: HF10 plus Ipilimumab
Patients will receive the dose of 1 x 10^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) and ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
Other Name: YERVOY (for ipilimumab)
The study is designed to assess efficacy and safety with repeated administration of intratumoral injections of HF10 at 1x10^7 TCID50/mL in combination with intravenous infusions of 3mg/kg ipilimumab. This is a single arm, open label Phase II trial, to evaluate the efficacy, safety and tolerability of HF10 treatment in combination with administration of the immunologic checkpoint inhibitor, ipilimumab (anti-CTLA-4 monoclonal antibody). The study population will include patients with Stage IIIB, IIIC or IV unresectable or metastatic malignant melanoma who are ipilimumab-eligible.
Patients will receive the dose of 1 x 10^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) + ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
Following combination therapy, patients may continue to receive the same dose level of HF10 (1 x 10^7 TCID50/mL) alone for up to an additional 13 injections (total of 19 injections = 1 year) if they have tolerated the study treatment, are responding, have stable disease, or have progressive disease that is not clinically significant in the judgment of the Investigator.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02272855
|United States, California|
|San Francisco, California, United States, 94115|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Oregon|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Bethlehem, Pennsylvania, United States, 18015|
|Hershey, Pennsylvania, United States, 17033|
|United States, Texas|
|Dallas, Texas, United States, 75230|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Salt Lake, Utah, United States, 84112|
|Principal Investigator:||Robert Andtbacka||University of Utah|