Cell based treatment in combination with checkpoint inhibitors for ovarian-, fallopian tube and primary peritoneal cancer.

Phase 1

• Conditions: Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer.; MedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10016183Term: Fallopian tube cancer NOSSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002179-24-DK
• Lead Sponsor: Center for Cancer Immune Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-15
• Study Completion: 2020-06-01
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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
11.Willingness to participate in the planned controls and capable of handling toxicities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

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.
11.Simultaneous treatment with other systemic anti-cancer treatments.
12.Patients with active and uncontrollable hypercalcaemia.

* 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.
** 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified