Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

NCT03714828 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 180773897529088
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).

Conditions

Squamous Cell Carcinoma; Skin Cancer; Keratoacanthoma; Cutaneous Tumor; Skin Cancer, Squamous Cell; Lesion Skin

Keywords

Skin cancer; Squamous cell; Squamous Cell Carcinoma; Skin lesion; Keratoacanthoma; talimogene laherparepvec

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).

  8.5-10.5 months

Secondary Outcomes (9)

• Number of Participants With Events Requiring the Discontinuation of Study Drug

  8.5-10.5 months

• Time of Response.

  8.5-10.5 months

• Duration of Overall Response.

  8.5-10.5 months

• Assess Durable Response.

  8.5-10.5 months

• Time to Progression.

  8.5-10.5 months

Study Arms (1)

Treatment (talimogene laherparepvec)

EXPERIMENTAL

The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors.

Drug: Injection of TVEC into target lesions - week 1-2; Drug: Injection of TVEC into target lesions 3wks after 1st injection; Drug: Injection of TVEC into target lesions 2wks after 2nd injection; Drug: Injection of TVEC into target lesions 2wks after 3rd injection

Interventions

Injection of TVEC into target lesions - week 1-2 DRUG

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient.

Treatment (talimogene laherparepvec)

Injection of TVEC into target lesions 3wks after 1st injection DRUG

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the second and subsequent doses.

Treatment (talimogene laherparepvec)

Injection of TVEC into target lesions 2wks after 2nd injection DRUG

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Treatment (talimogene laherparepvec)

Injection of TVEC into target lesions 2wks after 3rd injection DRUG

Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.

Treatment (talimogene laherparepvec)

Eligibility Criteria

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

You may qualify if:

• Able to give informed consent in English or Spanish
• Age \> 18
• Have at least one \>0.5 cm to \<5.0 cm, histologically confirmed low risk cutaneous SCC (including kerathoacanthomas)
• Size \>0.5 cm on trunk or extremities (excluding face, neck feet, nail units, and ankles)
• Clinically consistent with primary tumors.
• Lesion considered unresectable (as defined in Section 1.2)
• No immunosuppression
• Not a site of previous radiation therapy or chronic significant inflammation
• Fast growing lesions (doubling in size over a 4 week period of time) will be included if they are clinically suggestive of cSCC of the keratoacanthoma type.
• Well or moderately differentiated tumor as confirmed by skin biopsy
• Depth less than 2 mm (for non KA type cSCC )
• No perineural or vascular involvement in preliminary biopsy.
• Partial biopsy of squamous cell skin cancer identified as a target lesion(s) to determine the histological differentiation of the tumor or other adverse histological features
• In patients with multiple lesions, up to 3 lesions in a similar anatomical site, (trunk, limbs etc) that is at least 10 cm apart can be selected.
• Maximum of 5 lesions per patient can be selected for treatment

You may not qualify if:

• Any patient with diagnosis of invasive cancer in the last 3 years with the exception of stage I and II melanoma, cutaneous BCC and SCCs will be excluded.
• Subjects on acitretin, capecitabine, topical chemotherapies or treatments.
• History or evidence of symptomatic autoimmune disease (eg, pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. Replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
• Evidence of clinically significant immunosuppression such as the following:
• Primary immunodeficiency state such as Severe Combined Immuno deficiency Disease
• Acquired immunodeficiency syndrome
• Concurrent opportunistic infection
• Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 2 months prior to enrollment.
• Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis).
• Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
• Previous treatment with talimogene laherparepvec or any other oncolytic virus
• Prior therapy with tumor vaccine
• Received live vaccine within 28 days prior to enrollment. 24 \| Page Version 6-26-2018
• Currently receiving treatment with another investigational device or drug study, or \< 28 days since ending treatment with another investigational device or drug study(s)
• Other investigational procedures while participating in this study are excluded.

Sponsors & Collaborators

• University of Arizona: lead
• Amgen: collaborator

Study Sites (2)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Skin Neoplasms; Keratoacanthoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clara Curiel-Lewandrowski, MD
• Organization: University of Arizona Cancer Center

ccuriel@arizona.edu

(520) 626-5351

Study Officials

• Clara Curiel, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 22, 2018
• Study Start: December 20, 2018
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Locations

US (2)