Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

NCT02014441 | Completed Phase 2 Results

• 1 other identifier: 20120324
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 14

Brief Summary

The primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles

  Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported. The first cycle was 21 days in length, and subsequent cycles were 14 days in length.

  Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

Secondary Outcomes (34)

• Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood

  Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

• Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine

  Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

• Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles

  Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

• Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles

  Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

• Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles

  Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).

Study Arms (1)

Talimogene Laherparepvec

EXPERIMENTAL

Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter. Participants were treated with talimogene laherparepvec until they achieved a complete response (CR), all injectable tumors had 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 occurred first.

Drug: Talimogene laherparepvec

Interventions

Talimogene laherparepvec DRUG

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.

Also known as: IMLYGIC®, OncoVEX^GM-CSF

Talimogene Laherparepvec

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 herpes simplex virus type 1 ( 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (14)

Research Site

Tampa, Florida, 33612, United States

Location

Research Site

Indianapolis, Indiana, 46202, United States

Location

Research Site

Louisville, Kentucky, 40202, United States

Location

Research Site

Fridley, Minnesota, 55432, United States

Location

Research Site

Minneapolis, Minnesota, 55407, United States

Location

Research Site

New Brunswick, New Jersey, 08903, United States

Location

Research Site

Albuquerque, New Mexico, 87106, United States

Location

Research Site

Winston-Salem, North Carolina, 27157, United States

Location

Research Site

Germantown, Tennessee, 38138, United States

Location

Research Site

Dallas, Texas, 75230, United States

Location

Research Site

Salt Lake City, Utah, 84112, United States

Location

Research Site

Calgary, Alberta, T2N 4N2, Canada

Location

Research Site

Edmonton, Alberta, T6G 1Z2, Canada

Location

Research Site

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• Andtbacka RHI, Amatruda T, Nemunaitis J, Zager JS, Walker J, Chesney JA, Liu K, Hsu CP, Pickett CA, Mehnert JM. Biodistribution, shedding, and transmissibility of the oncolytic virus talimogene laherparepvec in patients with melanoma. EBioMedicine. 2019 Sep;47:89-97. doi: 10.1016/j.ebiom.2019.07.066. Epub 2019 Aug 10.

  PMID: 31409575 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Melanoma

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 18, 2013
• Study Start: April 7, 2014
• Primary Completion: January 25, 2016
• Study Completion: April 19, 2018
• Last Updated: November 20, 2019
• Results First Posted: February 14, 2017

Record last verified: 2019-11

Locations

CA (3); US (11)