About this trial
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.
Eligibility criteria
Qualifiers
Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.
At least 1 but no more than 4 lines of prior systemic therapy with no more than 2 lines of chemotherapy in any setting (ie, neoadjuvant or adjuvant setting as well as for recurrent, metastatic, or primary unresectable disease. .
Participants have received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
Participants who declined platinum-based chemotherapy regimen and/or an anti-PD-1/PD-L1 therapy or were deemed ineligible for such therapies by the investigator may be considered after discussion with the medical monitor.
Disqualifiers
Participants who have symptomatic untreated brain metastases.
Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
Participants who require systemic steroid therapy > 10 mg/day prednisone or another steroid equivalent dose.
Participants who have any form of primary immunodeficiency.
Trial design
Treatments tested in this trial
- Lifileucel