Overview

This trial is active, not recruiting.

Condition melanoma
Treatment talimogene laherparepvec
Phase phase 2
Target filgrastim
Sponsor Amgen
Start date April 2014
End date January 2016
Trial size 61 participants
Trial identifier NCT02014441, 20120324

Summary

A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Talimogene laherparepvec
talimogene laherparepvec
Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.

Primary Outcomes

Measure
Detection of talimogene laherparepvec DNA
time frame: 8 weeks following last subject enrolled

Secondary Outcomes

Measure
Clearance of talimogene laherparepvec DNA
time frame: 8 weeks following last subject enrolled
Rate of detection and subject incidence of talimogene laherparepvec DNA
time frame: 8 weeks following last subject enrolled
Incidence of detection of talimogene laherparepvec DNA
time frame: 2 years
Objective Response Rate (ORR), best overall response rate (BORR), duration of response (DOR), and durable response rate (DRR)
time frame: 2 years
Safety profile of talimogene laherparepvec
time frame: 2 years
Rate of detection and subject incidence of talimogene laherparepvec DNA
time frame: 8 weeks following last subject enrolled

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Key Inclusion Criteria: Male or female age ≥ 18 years with histologically confirmed diagnosis of melanoma and unresected stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c regardless of prior line of therapy. Subject is candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal disease and must also have measurable disease, serum lactate dehydrogenase ≤ 1.5 x upper limit of normal, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, hepatic, and renal organ function. Key Exclusion Criteria: Subject must not have clinically active cerebral metastases, greater than 3 visceral metastases (this does not include lung metastases or any nodal metastases associated with visceral organs) or any bone metastases melanoma, primary ocular or mucosal melanoma, history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or symptomatic autoimmune disease, or evidence of immunosuppression for any reason. Subject known to have acute or chronic active hepatitis B or hepatitis C infection, or human immunodeficiency virus infection will also be excluded. Subject who has active herpetic skin lesions or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis), and/or requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use will also be excuded. Subject must not have received previous treatment with talimogene laherparepvec.

Additional Information

Official title A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma
Description This is a phase 2, multicenter, and single arm study to investigate the biodistribution and shedding of talimogene laherparepvec in subjects with unresected, stage IIIB to IVM1c melanoma. Subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumors have disappeared, clinically relevant (resulting in clinical deterioration or requiring change of therapy) disease progression per modified World Health Organization (WHO) response criteria beyond 6 months of therapy, or intolerance of study treatment, whichever occurs first.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Amgen.
Location data was received from the National Cancer Institute and was last updated in June 2016.