Overview

This trial is active, not recruiting.

Condition unresected stage iiib to ivm1c melanoma
Treatment talimogene laherparepvec
Phase phase 2
Target filgrastim
Sponsor Amgen
Start date April 2015
End date June 2017
Trial size 112 participants
Trial identifier NCT02366195, 20120325, 2013-005552-15

Summary

The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between CD8+ cell density and objective response rate in subjects with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
talimogene laherparepvec
Open label Single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 10^6 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 10^8 PFU/mL.

Primary Outcomes

Measure
Correlation
time frame: 24 months following last subject enrolled

Secondary Outcomes

Measure
Objective Response Rate assessed by Modified World Health Organization (WHO) Response Criteria
time frame: 24 months following last subject enrolled
Correlation
time frame: 24 months following last subject enrolled
Correlation
time frame: 24 months following last subject enrolled
Safety as measured by incidence of adverse events
time frame: First dose through 30 days after last dose of talimogene laherparepvec
Change in tumor burden during treatment
time frame: 24 months following last subject enrolled
Duration of Response
time frame: 24 months following last subject enrolled
Time to Treatment Failure
time frame: 24 months following last subject enrolled
Durable Response Rate
time frame: 24 months following last subject enrolled
Overall Survival
time frame: 24 months following last subject enrolled

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Provided informed consent prior to initiation of any study-specific activities/procedures 2. Subject with stage IIIB to IVM1c melanoma for whom surgery is not recommended 3. Candidate for intralesional therapy 4. Measurable disease with greatest diameter ≥ 10 mm 5. ECOG performance status of 0 or 1 6. Adequate organ function Other Inclusion Criteria May Apply Exclusion Criteria: 1. Clinically active cerebral metastases. 2. Bone metastases 3. Primary ocular or mucosal melanoma 4. Active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) 5. Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use 6. Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec 7. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception Other Exclusion Criteria May Apply

Additional Information

Official title Phase 2, Open-Label, Single-arm Trial to Evaluate the Correlation Between ORR and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma With Talimogene Laherparepvec
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Amgen.
Location data was received from the National Cancer Institute and was last updated in July 2016.