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.
The OVACT study is the First in Human clinical evaluation of Cryptivax-1001 in patients with advanced high-grade serous or predominantly serous ovarian, fallopian tube, or primary peritoneal cancer, following optimal debulking surgery (R0 or R1 after either IDS or PDS), and no recurrence or progression after completion of platinum-based chemotherapy. This phase I/Ib dose escalation and expansion study will assess safety, tolerability, and immunogenicity in a population where there is a high unmet need and no clearly effective maintenance therapy options. By focusing on the BRCAwt/HRP subgroup, the study addresses the majority of patients who currently lack access to biologically-matched maintenance strategies. The study consist of 2 parts - a dose escalation part and an optional dose expansion part
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
i.m injection
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, United Kingdom
RECRUITINGThe University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
NOT_YET_RECRUITINGBeatson West of Scotland Cancer Centre
Glasgow, United Kingdom
RECRUITINGSt. James's University Hospital
Leeds, United Kingdom
RECRUITINGUniversity Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
Leicester, United Kingdom
RECRUITINGUniversity College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
London, United Kingdom
RECRUITINGGuy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, United Kingdom
NOT_YET_RECRUITINGRoyal Marsden NHS Foundation Trust - Royal Marsden Hospital
London, United Kingdom
RECRUITINGLancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, United Kingdom
RECRUITINGRoyal Marsden NHS Foundation Trust - Institute of Cancer Research
Sutton, United Kingdom
RECRUITINGTo evaluate the safety and tolerability of CryptiVax-1001
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events
Time frame: Through study completion, an average of up 2 to years
To evaluate the safety and tolerability of CryptiVax-1001
Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
Time frame: From Day 1 to Day 21
To evaluate the safety and tolerability of CryptiVax-1001
Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)
Time frame: Through study completion, an average of up to 2 years
To evaluate the safety and tolerability of CryptiVax-1001
Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
Time frame: Through study completion, and average of up to 2 years
To characterise the immunogenicity of Cryptivax-1001
Detection and quantification of antigen-specific T cells in peripheral blood at predefined timepoints
Time frame: At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
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