Status:
COMPLETED
TIL Therapy in Combination With Checkpoint Inhibitors for Metastatic Ovarian Cancer
Lead Sponsor:
Inge Marie Svane
Conditions:
Metastatic Ovarian Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 inv...
Detailed Description
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 inv...
Eligibility Criteria
Inclusion
- Only patients within the Danish healthcare system are eligible for enrollment.
- Histological proven advanced ovarian-, fallopian tube or primary peritoneal cancer with the possibility of surgical removal of tumor tissue of \> 1 cm3.
- Progressive or recurrent resistant disease after platin-based chemotherapy (platinum resistant) or progressive or recurrent disease after second line or additional chemotherapy.
- Age: 18 - 70 years.
- ECOG performance status of ≤1 (Appendix 2).
- Life expectancy of \> 6 months.
- At least one measurable parameter in accordance with RECIST 1.1 -criteria's.
- No significant toxicities or side effects from previous treatments, except sensoric- and motoric neuropathy and/or alopecia
- Sufficient renal, hepatic and hematological function
- Men and women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment.
- Able to comprehend the information given and willing to sign informed consent
Exclusion
- Other malignancies, unless followed for ≥ 5 years with no sign of disease
- Known hypersensitivity to one of the active drugs or one or more of the excipients.
- Severe medical or psychiatric conditions
- Creatinine clearance \< 70 ml/min. In selected cases it can be decided to include a patient with a GFR \< 70 ml/min with the use of a reduced dose of chemotherapy.
- Acute/chronic infection with HIV, hepatitis, syphilis among others.
- Severe allergies or previous anaphylactic reactions.
- Active autoimmune disease
- Pregnant women and women breastfeeding.
- Need for immunosuppressive treatment e.g. corticosteroids or methotrexate. In selected cases a systemic dose of ≤10 mg prednisolone or a transient planned treatment that can be stopped before TIL therapy can be tolerated.
- Simultaneous treatment with other experimental drugs.
- Simultaneous treatment with other systemic anti-cancer treatments.
- Patients with active and uncontrollable hypercalcaemia.
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03287674
Start Date
October 9 2017
End Date
June 1 2020
Last Update
March 1 2023
Active Locations (1)
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1
Center for Cancer Immune Therapy Dept. of Hematology/oncology
Copenhagen, Denmark, 2730