Clinical Trials Logo
  1. Home
  2. Sarcoma
  3. NCT03886311

Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma — TNT  

Sarcoma Clinical Trial

Official title:
The TNT Protocol: A Phase 2 Study Using Talimogene Laherparepvec,Nivolumab and Trabectedin as First, Second/Third Line Therapy for Advanced Sarcoma, Including Desmoid Tumor and Chordoma

Clinical Trial Summary

This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma.

Clinical Trial Description

This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma. The primary objective is to determine progression-free survival (PFS) at month 12. The secondary objectives are (1) To evaluate the best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI at 6,12,18, and 24 weeks post treatment, (2) To determine progression-free survival rate (PFS) at 6 and 9 months, (3) To determine overall survival rate at 6, 9, and 12 months, (4) To determine the incidence of conversion of an unresectable tumor to a resectable tumor, and (5) To evaluate the incidence of adverse events related to TALIMOGENE LAHERPAREPVEC in combination with nivolumab and trabectedin. The exploraratory objective is to correlate response with immune cell trafficking in the tumor microenvironment (TME) of resected tumors. The primary endpoint is Progression free survival at month 12. The secondary endpoints are: 1) Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI at 6,12,18 and 24 weeks post treatment, 2) PFS rate at 6 and 9 months • Overall survival rate at 6, 9, and 12 months, 3) Incidence of conversion of an unresectable tumor to a resectable tumor, 4) Incidence of adverse events related to TALIMOGENE LAHERPAREPVEC in combination with nivolumab and trabectedin. The exploratory endpoint is correlation of response with immune cell trafficking in the tumor microenvironment of resected tumors. Forty male and female subjects > 18 years of age, of any ethnicity, with advanced sarcoma, including desmoid tumor and chordoma will be treated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03886311
Study type Interventional
Source Sarcoma Oncology Research Center, LLC
Contact
Status Recruiting
Phase Phase 2
Start date May 15, 2019
Completion date March 31, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04457258 - 68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma Early Phase 1
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT04535713 - GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma Phase 2
Completed NCT03521531 - Burden and Medical Care of Sarcoma in Germany
Completed NCT02496520 - Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults Phase 1/Phase 2
Terminated NCT02054104 - Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum Phase 1/Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT04052334 - Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma Phase 1
Completed NCT01593748 - A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Recruiting NCT04367779 - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Completed NCT01879085 - Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma Phase 1/Phase 2
Recruiting NCT04553692 - Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers Phase 1
Completed NCT01209598 - PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma Phase 2
Completed NCT04553471 - Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers N/A
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2