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Cancer Vaccine for Ovarian Cancer (Cornerstone4 Trial)

Phase 2

Waitlist Available

Research Sponsored by Aston Sci. Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Can start adjuvant therapy within 6 weeks of debulking surgery

Must not have

Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24months from the first dose of ast-301 administration

Summary

This trial studies a cancer vaccine to treat advanced ovarian cancer after surgery, with or without chemotherapy.

Who is the study for?

This trial is for patients with advanced stage III ovarian cancer who've had surgery to remove most of the tumor and can start follow-up therapy within 6 weeks. They must have a specific type of tumor (HRP) and be in good health overall, with no severe allergies to rhuGM-CSF, recent cancers except certain skin or epithelial cancers, autoimmune or inflammatory diseases, active infections like TB or hepatitis, HIV, nor be pregnant.

What is being tested?

The study tests AST-201 (a therapeutic cancer vaccine) combined with rhuGM-CSF versus a placebo plus rhuGM-CSF. Both groups will also receive standard chemotherapy drugs Paclitaxel and Carboplatin. The goal is to see if AST-201 improves outcomes for those with newly diagnosed HRP ovarian cancer after surgery.

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine or GM-CSF, allergic responses to any component used in treatment including chemo drugs which may cause nausea, hair loss, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I can begin follow-up treatment within 6 weeks after my surgery to remove most of the cancer.

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I had surgery for my cancer and the remaining tumor is smaller than 1 cm.

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I have been newly diagnosed with stage III ovarian, peritoneal, or fallopian tube cancer.

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My tumor is HRP as confirmed by FDA-approved tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active infections like TB, hepatitis B, C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24months from the first dose of ast-301 administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24months from the first dose of ast-301 administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24months from the first dose of ast-301 administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

2-year PFS rate

AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )

Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AST-301Experimental Treatment4 Interventions

AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Group II: PlaceboPlacebo Group4 Interventions

Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450