T-cell therapy in combination with checkpoint inhibitors for patients with advanced ovarian-, fallopian tube- and primary peritoneal cancer.

Center for Cancer Immune Therapy0 sites6 target enrollmentJune 15, 2017

Overview

No summary available.

Registry

who.int

Start Date

June 15, 2017

End Date

June 1, 2020

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Center for Cancer Immune Therapy

•1\.Histological proven advanced ovarian\-, fallopian tube or primary peritoneal cancer with the possibility of surgical removal of tumor tissue of \> 1 cm3\. All histologies can be included.
•2\.Progressive or recurrent resistant disease after platin\-based chemotherapy (platinum resistant) or progressive or recurrent disease after second line or additional chemotherapy.
•3\.Age: 18 – 70 years.
•4\.ECOG performance status of \=1\.
•5\.Life expectancy of \> 6 months.
•6\.At least one measurable parameter in accordance with RECIST 1\.1 –criteria’s.
•7\.No significant toxicities or side effects (CTC \= 1\) from previous treatments, except sensoric\- and motoric neuropathy (CTC \= 2\) and/or alopecia (CTC \= 2\).
•8\.Sufficient organ functions.
•9\.Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
•10\.Signed statement of consent after receiving oral and written study information

•1\.A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 5 years after treatment.
•2\.Known hypersensitivity to one of the active drugs or one or more of the excipients.
•3\.Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.
•4\.Creatinine clearence \< 70 ml/min\*.
•5\.Acutte/chronic infection with HIV, hepatitis, syphilis among others.
•6\.Severe allergies or previous anaphylactic reactions.
•7\.Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
•8\.Pregnant women and women breastfeeding.
•9\.Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others)\*\*.
•10\.Simultaneous treatment with other experimental drugs.