NCT05756556

T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma

A Phase 2a, Open-label Study of T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: ImmVira Pharma Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of T3011 in combination with Cobimetinib in patients with advanced melanoma.

Detailed description

This is a phase 2a, open-label study of T3011 given via intratumoral (IT) injection in combination with Cobimetinib given via oral administration in patients with advanced melanoma. This study is planned to enroll approximately 62\~68 patients with BRAF V600E/V600K mutation-positive or RAS mutation-positive, which will be conducted in 2 parts (part 1 and part 2).

Conditions

• Melanoma
• Malignant Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	T3011 + Cobimetinib	1e8 plaque-forming units (PFU)/mL (up to 10 mL, every 2 weeks \[Q2W\], 28 days/cycle) T3011 will be administered in combination with 60 mg Cobimetinib (once daily \[QD\] for the first 21 days of each 28-day cycle)

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-12-31
• Completion: 2027-01-01
• First posted: 2023-03-06
• Last updated: 2024-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study