NCT02272855

A Study of Combination Treatment With HF10 and Ipilimumab in Patients With Unresectable or Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Takara Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if HF10 in combination with ipilimumab is effective in patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.

Detailed description

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2014-04-30
• Primary completion: 2016-10-01
• Completion: 2018-08-01
• First posted: 2014-10-23
• Last updated: 2018-09-26

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study