ID-LV305 / Merck (MSD) - LARVOL DELTA

NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed

Metastases • Trial completion • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A

NCI-2018-00926: Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A

Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Dec 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CTAG1B • HLA-A

A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. (PubMed, Oncoimmunology) - "It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein...Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A)...This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit."

Clinical • Journal • P1 data • Fatigue • Hepatology • Liposarcoma • Oncology • Pain • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1. (PubMed, Clin Cancer Res) - "This first-in-class, first-in-human study of LV305 demonstrated a favorable safety profile, induction of antigen-specific responses, and potential clinical activity in patients with advanced cancer."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Lung Cancer • Melanoma • Musculoskeletal Pain • Oncology • Pain • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer

Study of Adoptive Immunotherapy Using Autologous CD8+ NY-ESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 For Patients With Sarcoma (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center

New P1 trial • Biosimilar • Cardiovascular • Oncology • Reperfusion Injury • Sarcoma • Solid Tumor

Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: M.D. Anderson Cancer Center; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2019 ➔ Jun 2021; Trial primary completion date: Dec 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date

Modified T Cells, Chemotherapy, and Aldesleukin With or Without LV305 and CMB305 in Treating Participants With Advanced or Recurrent Sarcoma (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; N=12 ➔ 18

Clinical • Enrollment change

Study of Adoptive Immunotherapy Using Autologous CD8+ NY-ESO-1-Specific T Cells and the NY-ESO-1 Immunostimulatory Agents LV305 or CMB305 For Patients With Sarcoma (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting; N=18 ➔ 12

Clinical • Enrollment change • Enrollment closed

Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1 (clinicaltrials.gov) - P1; N=47; Completed; Sponsor: Immune Design; Active, not recruiting ➔ Completed; Trial completion date: Aug 2020 ➔ Dec 2018; Trial primary completion date: Dec 2017 ➔ Nov 2018

Clinical • Trial completion • Trial completion date • Trial primary completion date