NCT03711188

A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma

A Study of the Safety and Efficacy of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Immodulon Therapeutics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of the combination of IMM-101 with nivolumab.

Detailed description

This open-label study will assess the safety and efficacy of the combination of IMM-101 with nivolumab in patients with unresectable stage III, or stage IV melanoma who are either treatment-naive (cohort A) or whose disease has progressed during PD-1 blockade (cohort B). Ipilimumab may be used as a subsequent treatment in place of nivolumab alongside IMM-101 for patients in cohort B if their disease progresses on study. Eighteen patients will be enrolled into cohort A and 8 patients into cohort B.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.
DRUG	Ipilimumab	Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.
DRUG	IMM-101	A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

Timeline

• Start date: 2018-10-04
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2018-10-18
• Last updated: 2024-04-29
• Results posted: 2024-04-29

Locations

2 sites across 1 country: United Kingdom