Advanced Ovarian Cancer Vaccine Study (AST-201)

This study is testing a new therapeutic cancer vaccine, AST-201, for people with newly diagnosed advanced ovarian cancer (Stage III) that has a specific genetic feature called Homologous Recombination Proficiency (HRP). You would have already had surgery to remove as much of the cancer as possible. The study wants to see if adding AST-201, along with rhuGM-CSF (a protein that stimulates white blood cells), to standard chemotherapy (Paclitaxel and Carboplatin) can help you live longer without the cancer growing or coming back. Some participants will receive AST-201 and rhuGM-CSF, while others will receive a placebo (an inactive substance) and rhuGM-CSF, all in combination with standard chemotherapy. The study aims to enroll 98 participants.

Study design
This interventional study is comparing two groups of participants to see if adding AST-201 to standard chemotherapy improves outcomes. It plans to enroll 98 participants.
What's involved
You would undergo a screening period of up to 28 days, followed by approximately 5 months of treatment. The vaccine and rhuGM-CSF (or placebo) are given as injections under the skin every 3 weeks for 3 cycles, while chemotherapy is given every 3 weeks for 6 cycles.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits every 3 months for 2 years, then every 6 months until your disease progresses, you pass away, or you withdraw consent. The overall study duration is approximately 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05794659

Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Aston Sci. Inc.
~98 participants
Updated 2023-07-20 on ClinicalTrials.gov
What's tested:AST-201PaclitaxelCarboplatinPlaceborhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over overall study duration (approximately 48 months)
Advanced Ovarian Cancer
1 sites across 1 states
Washington1

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer
Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)
Can start adjuvant therapy within 6 weeks of debulking surgery
Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demonstrates adequate organ function.

Exclusion

Has a history of hypersensitivity or other contraindications to rhuGM-CSF
Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease
Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
Has active or prior autoimmune disease or inflammatory disease
Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study
  • Progression-Free Survival (PFS)overall study duration (approximately 48 months)

    the time from the date of randomization to disease progression, or death from any cause whichever occurs first