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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24months from the first dose of ast-301 administration
Awards & highlights
Cornerstone4 Trial 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.Check my eligibility
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.See study design
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.
Cornerstone4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
Select...
My tumor is HRP as confirmed by FDA-approved tests.
Cornerstone4 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
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 moreCornerstone4 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
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Aston Sci. Inc.Lead Sponsor
3 Previous Clinical Trials
189 Total Patients Enrolled
Hyunwon Shin, MD, PhDStudy Directorhyunwon.shin@astonsci.com
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I can begin follow-up treatment within 6 weeks after my surgery to remove most of the cancer.My organs are functioning well.I do not have active infections like TB, hepatitis B, C, or HIV.I have been on immune suppression therapy or stopped it less than 4 weeks ago.I haven't had cancer, except for certain skin cancers, in the last 5 years.I had surgery for my cancer and the remaining tumor is smaller than 1 cm.I have been newly diagnosed with stage III ovarian, peritoneal, or fallopian tube cancer.You have had a bad reaction to rhuGM-CSF in the past.My tumor is HRP as confirmed by FDA-approved tests.You currently have or have had an autoimmune or inflammatory disease.
Research Study Groups:
This trial has the following groups:- Group 1: AST-301
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What adverse effects could arise from the use of AST-301?
"AST-301 has been given a safety score of 2 by Power, as it is in the second phase of development. There have been studies that support its overall safety but no data demonstrating its effectiveness yet."
Answered by AI
Is there still an opportunity for participants to join this research endeavor?
"The public data hosted on clinicaltrials.gov indicates that this trail is not currently recruiting patients, though it had been posted initially on August 15th 2023 and was last updated March 20th of the same year. Although this trial is presently inactive, there are 537 other studies actively enrolling participants at present."
Answered by AI
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