Cell based treatment in combination with three 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: 21.0Level: 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: EUCTR2020-002738-34-DK
• Lead Sponsor: ational Center for Cancer Immune Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-02
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 18

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 – 75 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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

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 3 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 ( Except for anti-hormonal treatment. Physician’s evaluation is needed)
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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate toxicity (according to CTCAE version 4.0) and feasibility.;Secondary Objective: To evaluate treatment related immune responses<br>To evaluate clinical response (according to RECIST 1.1 - response rate,<br>progressionfree survival and overall survival);Primary end point(s): The primary endpoint is toxicity (according to CTCAE 4.0).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated before treatment, during<br>treatment and at follow-up visits untill 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are treatment related immune response and clinical<br>response (according to RECIST 1.1 - response rate, progressionfree<br>survival and overall survival).;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated after all patients have<br>received treatment and clinical response is evaluated. Estimated 1 year<br>after treatment of last patient.