Adoptive T cell therapy in patients with recurrent ovarian cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

• Age >= 18 years.
• OVACURE: Histologically proven epithelial ovarian cancer (EOC). Pre-OVACURE: Patients with stage IIIc or IV EOC that are treated with first line surgery can participate in the pre-OVACURE for TIL preservation out of the surgical specimen. In case of recurrent disease these TILs can be used.
• Recurrent ovarian cancer
• Presence of measurable progressive disease according to RECIST version 1.1 or
elevated CA125>2 times the upper normal limit (UNL) within 3 months and confirmed.
• Expected survival of at least 3 months.
• WHO performance status 0-2.
• Within the last 2 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
Hemoglobin >= 6,0 mmol/l
Granulocytes >= 1,500/µl
Lymphocytes >= 700/µl
Platelets >= 100,000/µl
Creatinine clearance >= 50 min/ml
Serum bilirubin <= 40 *mol/l
ASAT and ALAT <= 5 x the normal upper limit
LDH <= 2 x the normal upper limit
• Viral tests:
o Negative for HIV type 1/2, HTLV and TPHA
o No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum
o No antibodies against HCV (hepatitis C virus) in the serum
• Able and willing to give valid written informed consent.
• Prior treatment, including immunotherapy e.g. with anti-PD(L)1, is allowed but systemic therapy and radiotherapy must have been discontinued for at least two weeks before study entry.
• Patients should have disease progression.

Exclusion Criteria

• Patients with brain metastases.
• Clinically significant heart disease (NYHA Class III or IV).
• Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
• Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.
• Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and premalignant diseasein.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for follow-up assessments.
• Pregnancy or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- TIL (plus INFa) related toxicity according to NCI CTCAE v4.03</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Signs of activity:<br /><br>o Best overall response according to RECIST 1.1 and immune response criteria<br /><br>(irRC).<br /><br>o Disease control rate (DCR: CR+PR+SD) at 6 months.<br /><br>o Progression free survival and overall survival.<br /><br>o Analysis of underlying mechanisms by evaluation of hypothesis-related immune<br /><br>parameters (including immune modulation by chemotherapy, TIL and IFNa and<br /><br>functional capacity of TIL).</p><br>