NCT03070392

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Immunocore Ltd · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Detailed description

This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	IMCgp100	IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity
DRUG	Dacarbazine	Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity
BIOLOGICAL	Ipilimumab	Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments
BIOLOGICAL	Pembrolizumab	Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity

Timeline

• Start date: 2017-10-16
• Primary completion: 2020-10-13
• Completion: 2025-09-17
• First posted: 2017-03-03
• Last updated: 2026-03-17
• Results posted: 2021-09-14

Locations

57 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study