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New treatment option for Ovarian Cancer
Official title Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ClinicalTrials.gov ID: NCT07665515
What this study is testing
What is CryptiVax-1001?
CryptiVax-1001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Preston, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Edinburgh, United Kingdom; Glasgow, United Kingdom; Leeds, United Kingdom; Leicester, United Kingdom; London, United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.