CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
ONCOS-102 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003676
NCT03003676Phase 1Completed

A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After PD1 Blockade

Targovax Oy·interventional·Posted Dec 28, 2016·Updated Nov 8, 2021

In Brief

A Phase 1 clinical trial evaluating ONCOS-102, Cyclophosphamide, and 1 other intervention for Advanced or Unresectable Melanoma Progressing After PD1 Blockade. Completed, enrolled 21 participants across 4 sites in 2 countries.

Detailed Summary

This is a multi center, phase I pilot study of sequential ONCOS-102 and pembrolizumab in patients with advanced or unresectable melanoma progressing after PD1 blockade. The primary objective of the study is to determine the safety of sequential treatment with ONCOS-102 followed by pembrolizumab. The protocol aims to enroll patients into two cohorts: Part I: up to 12 patients will receive sequential treatment with ONCOS-102 followed by pembrolizumab. Part II: up to 12 patients will receive an initial treatment phase with ONCOS-102 followed by a treatment phase with ONCOS-102 in combination with pembrolizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 28, 2016
Enrollment StartDec 1, 2016
Primary CompletionJul 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.5 years ago

Interventions

ONCOS-102biological

Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)

Cyclophosphamidedrug

Pre-treatment

Pembrolizumabdrug

PD1 blockade