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JOURNAL ONKOLOGIE – STUDIE
20139157 T-VEC

T-VEC in Non-melanoma Skin Cancer

Rekrutierend

NCT-Nummer:
NCT03458117

Studienbeginn:
April 2018

Letztes Update:
19.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Basal Cell, Skin Neoplasms, Carcinoma, Merkel Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
University of Zurich

Collaborator:
-

Studienleiter

Reinhard Dummer, Prof. Dr.
Principal Investigator
vice-director dermatology

Kontakt

Emmanuella Guenova-Hötzenecker, PD Dr.
Kontakt:
Phone: +41 44 255 25 07
E-Mail: emmanuella.guenova@usz.ch
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Studien-Informationen

Detailed Description:

This study evaluates the administration of T-VEC in non-melanoma skin cancer. The aim is to

evaluate the effectiveness, safety and tolerability of T-VEC in patients with non-melanoma

skin cancer through determination of local immune effects after repeated T-VEC injections.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Subjects Age ≥ 18 years

- histologically confirmed diagnosis of locally advanced squamous cell carcinoma, basal

cell, carcinoma, Merkel cell carcinoma or cutaneous T cell lymphoma

- at least 1 injectable cutaneous lesion ≥ 20 mm in longest Diameter or multiple

injectable lesions that in Aggregate have a longest Diameter of ≥ 50 mm

- Eastern Cooperative Oncology Group-Status (ECOG Status) 0 or 1

- Adequate organ functions

Exclusion Criteria:

- Hypersensitivity to T-VEC or any of ist components

- Presence of organ and lymph node metastases

- history or evidence of active autoimmune disease that requires systemic Treatment

- Evidence of clinically significant immunosuppression

- active herpetic skin lesions or prior complications hereof

- pregnancy, breast feeding

- requires intermittent or chronic systemic Treatment with an antiherpetic drug

- acute or chronic active Hepatitis B or C infection or HIV infection

Studien-Rationale

Primary outcome:

1. Change from Baseline local immune effects after repeated T-VEC injections (Time Frame - at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)):
Detection of increased local immune activation markers in skin biopsies of injected lesions. The following markers will be assessed by Polymerase chain reaction (PCR): interferon (IFN), 2-prime, 5-prime oligoadenylate synthetase 1 (OAS1), Interferon-induced GTP-binding protein MxA (MXA) and C-X-C motif chemokine 11 (CXCL11)



Secondary outcome:

1. Detection of Tumor Regression using World Health Organization (WHO) response criteria (Time Frame - at baseline and at week 22):
Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study

2. Systemic immune response (Time Frame - at baseline and week 6, optionally also at week 12):
Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

3. Analysis of Adverse events (Time Frame - At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22):
All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of T-VEC will be recorded

Geprüfte Regime

  • Talimogene Laherparepvec (T-VEC):
    a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)

Quelle: ClinicalTrials.gov


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