drugset / Trial / NCT04611126

T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer

NCT04611126

Phase 1/2 Terminated 6 enrolled Inge Marie Svane
Non-randomizedSequentialOpen-labelTreatment

Summary

Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances. In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed. Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function. In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction. With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).

Timeline

Start
2021-04-22
Primary completion
2024-03-03
Completion
2024-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Relatlimab Monoclonal antibody 80 mg Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2