CompletedPhase 2

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

United States11 participantsStarted 2018-12-20

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. 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
✓. Adequate organ function determined within 28 days prior to enrollment, defined as follows:
✓. Hematology:

✕. 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:
✕. 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

Overall Response Rate

Timeframe: 8.5-10.5 months

NCT IDNCT03714828

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-19

Results submitted2024-07-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. 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
✓. Adequate organ function determined within 28 days prior to enrollment, defined as follows:
✓. Hematology:

✕. 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:
✕. 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