Ovarian CancerHGSOCHGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Investigational drug(s) / intervention(s)
CryptiVax-1001
CryptiVax-1001: i.m injection
Study summary
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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)
* Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).
* In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.
* A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.
* No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.
* Known BRCAwt status.
* HRP confirmed
* No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.
* ECOG performance status of 0 or 1.
* Adequate haematologic and organ function
* Negative pregnancy test for WOCBP.
* HLA type matching Cryptivax-1001
Exclusion Criteria:
* 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
* Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
* History of anaphylactic reaction to mRNA-LNP therapies.
* Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.
* Administration of any vaccine within 30 days prior to first dosing.
* Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.
Primary outcome measure(s)
To evaluate the safety and tolerability of CryptiVax-1001 — Through study completion, an average of up 2 to years Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events
To evaluate the safety and tolerability of CryptiVax-1001 — From Day 1 to Day 21 Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
To evaluate the safety and tolerability of CryptiVax-1001 — Through study completion, an average of up to 2 years Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)
To evaluate the safety and tolerability of CryptiVax-1001 — Through study completion, and average of up to 2 years Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
Trial sites (10)
Facility
City
Region
Status
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge
United Kingdom
Recruiting
The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
Edinburgh
United Kingdom
Not Yet Recruiting
Beatson West of Scotland Cancer Centre
Glasgow
United Kingdom
Recruiting
St. James's University Hospital
Leeds
United Kingdom
Recruiting
University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
Leicester
United Kingdom
Recruiting
University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
London
United Kingdom
Recruiting
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London
United Kingdom
Not Yet Recruiting
Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
London
United Kingdom
Recruiting
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston
United Kingdom
Recruiting
Royal Marsden NHS Foundation Trust - Institute of Cancer Research
Sutton
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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