TIL Therapy in Combination With Checkpoint Inhibitors for Metastatic Ovarian Cancer

Sponsor
Inge Marie Svane
Study ID
NCT03287674
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
  • Fludarabine — DRUG
    Fludarabine 25 mg/m2 is administered on day -5 to day -1.
  • TIL infusion — BIOLOGICAL
    The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
  • Interleukin-2 — DRUG
    Interleukin-2 is administered as a daily low-dose subcutaneous injection of 2 MIU for a total of 14 days.
  • Ipilimumab — DRUG
    One dose of Ipilimumab 3 mg/kg is administered 14 days prior to surgical removal of tumor tissue for TIL expansion.
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg is administered on day -2 before TIL infusion and every 2 weeks for a total of 4 doses.

Study Details

Adoptive T cell therapy (ACT) with tumor infiltrating lymphocytes (TIL) has achieved impressive clinical results with durable complete responses in patients with metastatic melanoma. Recently, the investigators have completed a pilot study treating 6 patients with metastatic ovarian cancer. The TILs are isolated from patients own tumor tissue followed by in vitro expansion and activation for around 4-6 weeks. Before TIL infusion the patients receive 1 week of preconditioning chemotherapy with cyclophosphamide and fludarabine. After TIL infusion Interleukin-2 is administered to support T cell activation and proliferation in vivo. The investigators recent pilot study has shown TIL therapy in patients with metastatic ovarian cancer to be feasible and tolerable. Mainly transient clinical responses where observed and therefore the investigators plan to combine TIL therapy with checkpoint inhibitors to potentially increase the clinical effect.

Key Dates

Start date
Oct 9, 2017
Status verified
Feb 2023
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patient group
    All patients receive the same treatment. All patients are treated with one dose of Ipilimumab 14 days prior to surgical removal of tumor tissue for TIL expansion. Hospitalization for TIL treatment is approximately 3 weeks. The patients are admitted to hospital on day -8 and receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine= on day -7 to day -1. The first of 4 doses of Nivolumab is administered on day -2 and every 2 weeks for at total of 4 doses. The TILs are infused on day 0 and Interleukin-2 therapy is administered on day 0 to day 13. Interleukin-2 is administered as a daily low-dose subcutaneous injection for a total for 14 days.

Primary Outcome Measure

Number of Participants With Reported Adverse Events by Type [ Time Frame: Up to 12 months ]

Related Studies