Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEpitopea Ltd
About this trial
Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.
The main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.
Following surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.
The main purposes of this study are therefore to:
* assess how well the study vaccine is tolerated and identify any side effects. * analyse the study vaccine's capacity to activate your immune system
The study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.
Eligibility criteria
Qualifiers
Able to comprehend and are willing to sign the ICF and willing to follow the study procedures
Female, aged 18 years of age or older at the time of informed consent.
Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes
The FIGO 2014 stage III or IV disease at initial diagnosis.
Disqualifiers
Non-epithelial or low malignant potential ovarian tumours
Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.
Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death
Active autoimmune disease requiring systemic immunosuppression
Trial design
Treatments tested in this trial
- CryptiVax-1001
Treatment groups
50 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov