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Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma

Melanoma Stage Iv Clinical Trial

Official title:
Open-label, Multi-center Phase IIa Study to Evaluate the Efficacy, Safety, and Immunological Response of OBP-301, Telomerase Specific Replication-competent Oncolytic Adenovirus in Patients With Unresectable Metastatic Melanoma

Clinical Trial Summary

Open-label, single-arm, multi-center, Phase IIa study to evaluate the efficacy, safety, and immunological response of OBP 301 in patients with unresectable/unresected metastatic melanoma. This proof of concept study will be undertaken in male and female patients with unresectable Stage III and IV melanoma. Patients with unresectable/unresected mucosal melanoma may be enrolled after consultation with the Medical Monitor.

Clinical Trial Description

Primary Objective:

The primary objective of this study is to evaluate the overall tumor sites response (objective response rate [ORR]) to OBP-301 in both injected and noninjected lesions up to and including Week 24 in patients with unresectable/unresected Stage III and IV melanoma. The ORR is defined as the rate of complete response (CR) and partial response (PR) based on the modified immune-related response criteria (irRC) 1.0. The modification is to allow the identification of up to 10 cutaneous, subcutaneous, and/or lymph node tumor lesions and identify the lesions as target and nontarget lesions.

Secondary Objectives:

- To evaluate the ORR up to and including Week 24 in injected target lesions based on the modified irRC 1.0 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- To evaluate the ORR up to and including Week 24 in noninjected target lesions based on modified irRC 1.0 and RECIST 1.1

- To evaluate the ORR in both injected and noninjected target lesions at Week 12 based on the modified irRC 1.0 and RECIST 1.1

- To evaluate duration of response and time to response

- To evaluate progression free survival (PFS) at Week 24 and Week 48

- To evaluate overall survival (OS) at Week 24 and Week 48

- To evaluate the safety of OBP 301

Exploratory Objective (optional):

The optional exploratory objective of this study is to investigate the tumor immunological response in blood and tumor tissue following treatment with OBP-301. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03190824
Study type Interventional
Source Syneos Health
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 22, 2016
Completion date October 31, 2021
View Details
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