Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery

Titre officiel

A Phase 2 Study of Talimogene Laherparepvec (T-VEC) and Radiation in Localized Soft Tissue Sarcoma

Sommaire:

Cet essai de phase II étudie les effets secondaires du talimogene laherparepvec et de la radiothérapie, et vise à déterminer leur efficacité dans le traitement des patients présentant un sarcome des tissus mous nouvellement diagnostiqué résécable. Les traitements biologiques tels que le talimogene laherparepvec, utilisent des substances fabriquées à partir d’organismes vivants qui peuvent stimuler ou inhiber le système immunitaire de différentes manières et arrêter la croissance des cellules cancéreuses. La radiothérapie administre des photons, des électrons, des protons ou des rayons X à haute énergie afin de tuer les cellules tumorales et de réduire la taille des tumeurs. L’administration de talimogene laherparepvec et la radiothérapie peuvent s’avérer plus efficaces dans le traitement des sarcomes des tissus mous.

Description de l'essai

Primary Outcome:

  • Pathologic complete response (CR) rate
  • Incidence of post-surgical wound complications
Secondary Outcome:
  • Incidence of toxicities of T-VEC in combination with radiation therapy
  • Rate of radiologic response
  • Rate of surgical response
  • Time to surgery
  • Time to progression
  • Time to recurrence
  • Time to death
PRIMARY OBJECTIVE:
  • To estimate the pathologic complete necrosis rate (the number of patients with >= 95% necrosis divided by the number of evaluable patients) following preoperative treatment with talimogene laherparepvec (T-VEC) in combination with radiation in patients with localized soft tissue sarcoma including a pre-planned interim safety analysis to assess post-surgical wound complications.
SECONDARY OBJECTIVES:
  • To estimate the toxicity of talimogene laherparepvec (T-VEC) in combination with radiation in localized soft tissue sarcomas, during neo-adjuvant treatment and post-surgical resection wound complications.
  • To estimate the rate of radiologic response, prior to surgery, and extent of surgical resection.
  • To estimate time to surgery, time to progression, time to recurrence, and death.
CORRELATIVE OBJECTIVES:
  • To characterize the clinical outcomes within three distinct histologic subtypes: liposarcoma (excluding myxoid liposarcoma), leiomyosarcoma and undifferentiated pleomorphic sarcoma.
  • To characterize the percentage of tumour necrosis in treated tumours.
  • To assess if the combination of preoperative talimogene laherparepvec (T-VEC) with radiation will increase the expression of PD-L1 in soft tissue sarcomas.
  • To assess the impact of preoperative talimogene laherparepvec (T-VEC) with radiation on the tumour infiltrating and circulating immune cells in patients with soft tissue sarcomas.
OUTLINE:
Patients receive talimogene laherparepvec intratumourally (IT) or via intralesional injection at weeks 1, 4, 6 and 8. Beginning 1 week after the start of talimogene laherparepvec, patients undergo radiation therapy on Monday-Friday of weeks 2-6. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then every year for up to 5 years.

Voir cet essai sur ClinicalTrials.gov

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