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TIL Therapy in Combination With Checkpoint Inhibitors for Metastatic Ovarian Cancer

NCT03287674 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-03-01

Study results available
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Summary

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.

Conditions

  • Metastatic Ovarian Cancer

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.

DRUG

Fludarabine

Fludarabine 25 mg/m2 is administered on day -5 to day -1.

BIOLOGICAL

TIL infusion

The maximum number of expanded TILs are infused over 30-45 minutes on day 0.

DRUG

Interleukin-2

Interleukin-2 is administered as a daily low-dose subcutaneous injection of 2 MIU for a total of 14 days.

DRUG

Ipilimumab

One dose of Ipilimumab 3 mg/kg is administered 14 days prior to surgical removal of tumor tissue for TIL expansion.

DRUG

Nivolumab

Nivolumab 3 mg/kg is administered on day -2 before TIL infusion and every 2 weeks for a total of 4 doses.

Sponsors & Collaborators

  • Inge Marie Svane

    lead OTHER

Principal Investigators

  • Inge Marie Svane, Prof., M.D. · Center for Cancer Immune Therapy, Depth of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730

  • Magnus Pedersen, M.D. · Center for Cancer Immune Therapy, Depth of Hematology/Oncology, Copenhagen University Hospital Herlev, Herlev Ringvej 75, DK-2730

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287674 on ClinicalTrials.gov