OVAFIT-TIL: A Phase Ib Study of Autologous, Metabolically Optimized, CD137+ Tumor-Infiltrating Lymphocytes Followed by Consolidative Oral Cyclophosphamide, Bevacizumab, and Pembrolizumab in Recurrent Ovarian Cancer
Medical University of South Carolina
Summary
Patients with recurrent ovarian cancer will undergo resection of a safely accessible metastatic lesion, from which tumor-infiltrating lymphocytes (TIL) will be cultured, metabolically reprogrammed for metabolic fit T cells, then selected for CD137+ activated T cells, and then expanded. This expanded TIL product will be infused following nonmyeloablative lymphodepletion chemotherapy. High-dose IL-2 will be given after TIL infusion to support the cell product expansion. Once recovered from TIL infusion, patients will start consolidative systemic therapy with oral cyclophosphamide, bevacizumab, and pembrolizumab.
Eligibility
- Age range
- 18–80 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 5.1.1 STEP 1: RESECTION OF TUMOR \& INITIATION OF TIL EXPANSION Patients must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion. 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Female, aged 18 to 80 years. 4. Patients must have recurrent epithelial ovarian cancer, all subtypes will be eligible. 5. Measurable disease for target lesion(s) per RECIST prior to resection. If only one…
Interventions
- DrugFludarabine
25 mg/m2/day
- DrugCyclophosphamide
60 mg/kg/day IV
Location
- Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina