T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma

Phase 2

Suspended

• Conditions: Malignant Melanoma; Melanoma
• Interventions: Combination Product: T3011 + Cobimetinib

• Registration Number: NCT05756556
• Lead Sponsor: ImmVira Pharma Co. Ltd

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Study Start: 2024-06-30
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 2a	T3011 + Cobimetinib	T3011 given via intratumoral (IT) injection in combination with Cobimetinib via oral administration in patients with advanced melanoma.

Primary Outcome Measures

Name	Time	Method
ORR	up to 5 years after the first dose of the last patient, depending on the actual situation.	defined as the proportion of patients with a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST version 1.1
Characterize the safety and tolerability of T3011 in combination with Cobimetinib.	up to 5 years after the first dose of the last patient, depending on the actual situation.	Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs) (part 1 only), adverse event of special interest (AESIs), abnormal clinically significant vital signs, physical examination, and laboratory tests, with severity determined according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up to 5 years after the first dose of the last patient, depending on the actual situation.	defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST version 1.1
Disease control rate (DCR)	up to 5 years after the first dose of the last patient, depending on the actual situation.	defined as the proportion of patients who have a best overall response of CR or PR or SD, as determined by the investigator according to RECIST version 1.1.
Duration of response (DOR)	up to 5 years after the first dose of the last patient, depending on the actual situation.	defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST version 1.1.
European Organization for Research and Treatment of Cancer Questionnaire Core 30 (EORTC QLQ-C30)	up to 5 years after the first dose of the last patient, depending on the actual situation.	Change from baseline in the European Organization for Research and Treatment of Cancer Questionnaire Core 30 (EORTC QLQ-C30) (version 3.0) at subsequent visits protocol required.
Overall Survival (OS)	up to 5 years after the first dose of the last patient, depending on the actual situation.	defined as the time from initiation of study treatment to death from any cause

Trial Locations

Locations (1)

Gabrail Cancer and Research Center; 🇺🇸 Canton, Ohio, United States