NCT05928962

An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas

PD-1 Monoclonal Antibody With Recombinant Human Adenovirus Type 5 Injection for the Treatment of Advanced Malignant Melanoma Patients Who Has Failed Immunotherapy: an Exploratory Single-arm Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is provide new treatment for patients with advanced melanoma who have failed previous immunotherapy. The main questions it aims to answer are: * Efficacy of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma. * Safety of PD1 monoclonal antibody combined with recombinant human adenovirus type 5 injection in patients with advanced malignant melanoma.

Detailed description

The study is divided into 5 phases: screening phase, washout phase, baseline phase, treatment phase and follow-up phase. Patients with advanced malignant melanoma who are eligible for screening and have failed previous anti-PD1 antibody therapy and who meet the inclusion exclusion criteria undergo elution with 1 PD1 monoclonal antibody injection, patients whose tumours progress after PD1 monoclonal antibody injection enter the treatment phase and are followed up every 1 month for at least 2 years in the follow-up phase.

Conditions

• Malignant Melanomas

Interventions

Type	Name	Description
DRUG	Recombinant Human Adenovirus Type 5 Injection	1. Recombinant Human Type 5 Adenovirus Injection: This is expected to be administered prior to immunotherapy, i.e. scheduled for injection at C1D1 (C2D1, C3D1, C4D1). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles. 2. PD1 monoclonal antibody (Tremelimumab): Administered intravenously within 48h of recombinant human adenovirus type 5 injection, scheduled at C1D2 (C2D2, C3D2, C4D2). 1 treatment period every 2 weeks (3 day window) for a total of 4 cycles.

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-08-01
• Completion: 2024-10-31
• First posted: 2023-07-03
• Last updated: 2023-07-10

Locations

1 site across 1 country: China