Squamous Cell Carcinoma Clinical Trial
— 20139157 T-VECOfficial title:
A Phase I, Open Label, Single Arm, Single Centre Study to Evaluate Mechanism of Action of Talimogene Laherparepvec (T-VEC) in Locally Advanced Non-melanoma Skin Cancer
Verified date | March 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 15, 2022 |
Est. primary completion date | February 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Dermatology, University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline local immune effects after repeated T-VEC injections | 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) | at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12) | |
Secondary | Detection of Tumor Regression using World Health Organization (WHO) response criteria | Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study | at baseline and at week 22 | |
Secondary | Systemic immune response | Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS) | at baseline and week 6, optionally also at week 12 | |
Secondary | Analysis of Adverse events | 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 | At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02213133 -
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
|
Phase 2 | |
Not yet recruiting |
NCT04533321 -
A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma
|
Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Active, not recruiting |
NCT01232374 -
Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
Withdrawn |
NCT01148082 -
School Response to Families Who Have Children With Cancer
|
N/A | |
Completed |
NCT01208883 -
A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT01089803 -
Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
|
N/A | |
Terminated |
NCT00707655 -
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy
|
Phase 1/Phase 2 | |
Completed |
NCT00586040 -
Photochemical Tissue Bonding
|
Phase 2 | |
Completed |
NCT01127737 -
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
|
N/A | |
Completed |
NCT00793169 -
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
|
||
Completed |
NCT00409565 -
A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00176267 -
Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer
|
Phase 2 | |
Terminated |
NCT04685798 -
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
|
N/A | |
Recruiting |
NCT04370587 -
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04475952 -
Early Diagnosis of Upper Digestive Tract Disease
|
||
Recruiting |
NCT04435938 -
A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
Not yet recruiting |
NCT05852665 -
Buccal Cancer Resection Ultrasound Guided
|
N/A | |
Recruiting |
NCT05048459 -
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
|
N/A | |
Suspended |
NCT03952585 -
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
|
Phase 2/Phase 3 |