NCT03190824

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma Stage III
• Melanoma Stage Iv

Interventions

Type	Name	Description
DRUG	OBP-301	A novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.

Timeline

• Start date: 2016-12-22
• Primary completion: 2021-06-24
• Completion: 2021-10-31
• First posted: 2017-06-19
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study