NCT03458117

Brief Summary

Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

February 19, 2018

Last Update Submit

March 17, 2022

Conditions

Non-melanoma Skin CancerBasal Cell CarcinomaSquamous Cell CarcinomaCutaneous LymphomaMerkel Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Detection of Tumor Regression using World Health Organization (WHO) response criteria

    at baseline and at week 22

  • Systemic immune response

    at baseline and week 6, optionally also at week 12

  • Analysis of Adverse events

    At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22

Study Arms (1)

Talimogene Laherparepvec (T-VEC)

EXPERIMENTAL

Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)

Genetic: Talimogene Laherparepvec (T-VEC)

Interventions

Talimogene Laherparepvec (T-VEC)GENETIC

a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)

Talimogene Laherparepvec (T-VEC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Basal CellCarcinoma, Squamous CellLymphoma, T-Cell, CutaneousCarcinoma, Merkel Cell

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous CellLymphoma, T-CellLymphoma, Non-HodgkinLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPolyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalAdenocarcinomaNeoplasms, Nerve Tissue

Study Officials

  • Reinhard Dummer, Prof. Dr.

    vice-director dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 8, 2018

Study Start

April 19, 2018

Primary Completion

February 4, 2022

Study Completion

March 15, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)