CryptiVax-1001 maintenance vaccine for advanced ovarian, fallopian tube, or primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study tests CryptiVax-1001, a cancer vaccine, in patients with advanced high-grade serous ovarian cancer or related cancers after surgery and platinum-based chemotherapy. The trial uses a dose-escalation design to evaluate safety and tolerability, with an optional expansion phase to further explore immunogenicity. Participants will have completed initial therapy, achieved no progression, and have BRCA-wild-type or homologous recombination proficient disease. The study aims to identify side effects and determine if the vaccine can provoke an immune response that could help delay recurrence. It is conducted at multiple centers in the UK and addresses a population with limited biologically matched maintenance options.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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 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

Study contacts

• Principal investigator: Susana Banerjee, MBBS MA FRCP PhD — Royal Marsden NHS Foundation Trust
• Study coordinator: Head of Development Operations
• Email: Gertrud.Rasmussen@epitopea.com
• Phone: +4530660105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.