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

NCT03190824 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Melanoma Stage III
  • Melanoma Stage Iv

Interventions

DRUG

OBP-301

A novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.

Sponsors & Collaborators

  • Oncolys BioPharma Inc

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Principal Investigators

  • Principal Investigator · Institution

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2021-06-24
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190824 on ClinicalTrials.gov