Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma

NCT03921073 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: MCC-19878
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm study evaluating the efficacy of injecting Talimogene Laherparepvec T-VEC into Cutaneous Angiosarcoma tumors.

Conditions

Angiosarcoma of Skin

Keywords

Cutaneous; Angiosarcoma; Skin

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate is defined as the proportion of patients who demonstrate complete or partial responses in injected lesions per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria appropriate for cutaneous neoplasms (ORR=complete response + partial response).

  at 24 Weeks

Secondary Outcomes (5)

• Duration of Response

  at 4 weeks

• Progression-free Survival

  up to 2 years

• Complete Response Rate

  Baseline to 2 years

• T-VEC Treated Tumors Requiring Surgical Resection

  Baseline to 2 years

• Analyses of Immune Infiltration Within Resected Tumor Specimens

  Baseline to 2 years

Study Arms (1)

Intralesional injection of T-VEC

EXPERIMENTAL

Participants will undergo intralesional injections of up to 4 cc of 10\^6 plaque-forming units (PFU)/mL of T-VEC. Dose is dependent on the diameter of the lesions to be injected (volume injected is related to diameter of lesion(s) at time point 0). Three weeks later and every other week thereafter, the participants will be injected with up to 4 cc of 10\^8 PFU/mL, with dose dependent on the diameter of the lesion(s) to be injected. Participants may be treated for up to 12 months.

Drug: T-VEC

Interventions

T-VEC DRUG

Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.

Intralesional injection of T-VEC

Eligibility Criteria

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

You may qualify if:

• Participants must have histologically confirmed CA without visceral or CNS metastases, with resection deemed of no benefit by technical or oncologic principles, and have progressed on at least one line of systemic therapy
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded by digital photography) as \>6 mm with calipers or a ruler.
• Eastern Cooperative Oncology Group performance status 0-1 (Karnofsky \>70%).
• Participants must have normal organ and marrow function as defined below:
• Hematological
• Absolute neutrophil count \> 1500/mm3 (1.5x109/L)
• Platelet count \>75,000/mm3 (7.5x109/L)
• Hemoglobin \>8 g/dL (without need for hematopoietic growth factor or transfusion support)
• Renal
• Serum creatinine ≤1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance \>60 mL/min for subject with creatinine levels \> 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is ≤1.5 x ULN. . Creatinine clearance should be determined per institutional standard).
• Hepatic
• Serum bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level \> 1.5 x ULN
• Aspartate aminotransferase (AST) ≤2.5 x ULN OR \<5 x ULN, if liver metastases present and injection does not involve a visceral lesion
• Alanine aminotransferase (ALT) ≤2.5 x ULN OR \<5 x ULN, if liver metastases present and injection does not involve a visceral lesion
• Coagulation

You may not qualify if:

• Participants with a second active malignancy, exceptions are localized non-melanoma skin cancers or in situ carcinoma
• Participants receiving any other investigational agents
• Participants with tumor(s) in direct contact or encasing a major blood vessel, those with ulceration and/or fungation onto the skin surface, and those with history of re-irradiation or prior lymph node neck dissection to a field involving the carotid arteries
• History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Evidence of clinically significant immunosuppression such as the following:
• Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease.
• concurrent opportunistic infection.
• receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to enrollment.
• Active herpetic skin lesions or prior complications of HSV-1 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.
• Prior immunosuppressive, chemotherapy, radiotherapy (in which the field encompassed a planned injection site), biological cancer therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
• Prior radiotherapy in which the field does not overlap the injection sites or non-immunosuppressive targeted therapy within 14 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to enrollment

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Results Point of Contact

• Title: Dr. John Mullinax
• Organization: Moffitt Cancer Center

John.Mullinax@moffitt.org

813-745-1867

Study Officials

• John Mullinax, MD,

  H. Lee Moffitt Cancer Center and Research Institute

  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: April 15, 2019
• First Posted: April 19, 2019
• Study Start: August 20, 2019
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: November 1, 2022
• Results First Posted: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)