Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone4)

July 18, 2023 updated by: Aston Sci. Inc.

A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)

The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel/Carboplatin).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will comprise a screening period of -28 Days prior to initiation of study treatment (Day 1); an enrollment period of 24 months; the treatment duration will be approximately of 5 months.

The study will evaluate whether the addition of AST-201/rhuGM-CSF to the standard adjuvant chemotherapy will extend the Progression Free Survival(PFS) rate. Survival follow-up will be performed every 3 months (±14 days) after the End of treatment (EOT) visit for 2 years after randomization and every 6 months (±28 days) thereafter until disease progression or death from any cause or withdrawal of consent whichever comes first. Survival follow-up visits will be conducted by telephone, in-person visit, or chart review. The end of study (EOS) is defined as 2 years after the date of last patient enrollment.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington
        • Contact:
          • John B. Liao, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AST-301

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
Biological: AST-201
i.d. (3-week interval, 3 cycles in total)
Other Names:
  • pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine
Drug: Paclitaxel
3-week interval, 6 cycles in total
Other Names:
  • Taxol
Drug: Carboplatin
3-week interval, 6 cycles in total
Other Names:
  • Paraplatin
Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)
Other Names:
  • Leukine
  • sargramostim
Placebo Comparator: Placebo

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
Drug: Paclitaxel
3-week interval, 6 cycles in total
Other Names:
  • Taxol
Drug: Carboplatin
3-week interval, 6 cycles in total
Other Names:
  • Paraplatin
Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)
Other Names:
  • Leukine
  • sargramostim
Drug: Placebo
i.d. (3-week interval, 3 cycles in total)
Other Names:
  • Normal saline (USP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: overall study duration (approximately 48 months)
the time from the date of randomization to disease progression, or death from any cause whichever occurs first
overall study duration (approximately 48 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year PFS rate
Time Frame: 24months from the first dose of AST-301 administration
proportion of patients alive without disease progression or death at two years after the randomization
24months from the first dose of AST-301 administration
Overall Survival (OS)
Time Frame: overall study duration (approximately 48 months)
the time from the date of randomization to death from any cause
overall study duration (approximately 48 months)
AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
Time Frame: 17months
AST-201 specific IFN-gamma ELISpot
17months
Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
Time Frame: 5 months
Adverse events (AEs) Treatment-emergent adverse events (TEAEs) Serious adverse events (SAEs) Vital signs Physical examination Eastern Cooperative Oncology Group (ECOG) performance status Electrocardiogram (ECG) test Laboratory tests
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aston Sci. Inc.

Investigators

  • Study Director: Hyunwon Shin, MD, PhD, hyunwon.shin@astonsci.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN-201-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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