An open label, phase 1 study to evaluate the safety, feasibility and immunogenicity of an allogeneic, cell-based vaccine (DCP-001) in high grade serous ovarian cancer patients after primary treatment
- Conditions
- ovarian cancerOverian carcinoma1003859410033283
- Registration Number
- NL-OMON55212
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
- Primary HGSOC patients (FIGO stage 3B to IV) who completed primary treatment
defined as:
o primary debulking surgery (complete / optimal) and 6 cycles of adjuvant
chemotherapy (carboplatin/paclitaxel)
o 3 cycles of neo-adjuvant chemotherapy (more NACT cycles to improve
surgical outcome are allowed) followed by interval debulking surgery (complete
/ optimal) and 3 cycles of adjuvant chemotherapy (carboplatin/paclitaxel)
- Decreased CA125 compared to pre-treatment CA125
- Serum level CA125 < 100 kU/L
- Age >= 18 years
- Signed informed consent form (ICF) in accordance with institutional and
regulatory guidelines
- History of a second malignancy except for curatively treated low-stage tumors
with a histology that can be differentiated from the epithelial OC type
- Patients must have no ongoing or recent evidence (within the last 5 years) of
significant autoimmune disease that required treatment with systemic
immunosuppressive treatments which may suggest risk for immune-related adverse
events (irAEs).
Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related
hypothyroidism who are in remission, or on a stable dose of thyroid-replacement
hormone, vitiligo, or psoriasis may be included.
- Patients must have no uncontrolled infection with human immunodeficiency
virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
that is related to, or results in chronic infection. Mild cancer-related
immunodeficiency (such as immunodeficiency treated with gamma globulin and
without chronic or recurrent infection) is allowed.
o Patients with known HIV who have controlled infection (undetectable viral
load and CD4 count above 350 either spontaneously or on a stable antiviral
regimen) are permitted. For patients with controlled HIV infection, monitoring
will be performed per local standards.
o Patients with known hepatitis B (HepBsAg+) who have controlled infection
(serum hepatitis B virus DNA PCR that is below the limit of detection AND
receiving antiviral therapy for hepatitis B) are permitted. Patients with
controlled infections must undergo periodic monitoring of HBV DNA per local
standards. Patients must remain on anti-viral therapy for at least 6 months
beyond the last dose of trial treatment.
o Patients who are known hepatitis C virus antibody positive (HCV Ab+) who
have controlled infection (undetectable HCV RNA by PCR either spontaneously or
in response to a successful prior course of anti-HCV therapy) are permitted.
- Liver or renal function abnormalities that are considered to be clinically
relevant by the investigator.
- Abnormal blood levels (neutropenia among other things) due to chemotherapy
that are considered to be clinically relevant by the investigator.
o If so, blood levels will be repeated in 1-2 weeks, in case blood levels
are normalized the patient is allowed to be included in the study. In case of
persistent abnormal blood levels the patient will be excluded.
- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
p.o. >7.5 mg / day).
- Participation in a trial with another investigational drug within 30 days
prior to the enrolment in this trial
- Any condition that in the opinion of the investigator could interfere with
the conduct of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess whether the DCP-001 vaccine induces a systemic vaccine-specific<br /><br>immune response.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of the DCP-001 vaccine in ovarian cancer<br /><br>patients after primary treatment.<br /><br>Recurrence Free Survival<br /><br>Overall survival</p><br>