Study on Cancer Vaccine AST-201 for Patients with Advanced Ovarian Cancer

Sponsor: Aston Sci. Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05794659

Provider View

This clinical trial is testing a new cancer vaccine, AST-201, to see if it can help improve treatment outcomes for patients with advanced ovarian cancer. The study will compare the effects of the vaccine combined with standard chemotherapy to standard treatment alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new cancer vaccine, AST-201, can help patients with advanced ovarian cancer live longer without the cancer getting worse. The vaccine will be given along with standard chemotherapy drugs, Paclitaxel and Carboplatin, after surgery to remove as much of the cancer as possible. Some patients will receive the vaccine, while others will receive a placebo, both combined with a growth factor called rhuGM-CSF. The study will last about five months, with follow-up visits every few months to check on patients' health and cancer status.

Description

This study is designed to test the effectiveness and safety of a new cancer vaccine, AST-201, in patients with advanced ovarian cancer. The vaccine is given after surgery and alongside standard chemotherapy to see if it can help patients live longer without their cancer progressing. The study will last for about five months, with patients being monitored regularly to assess their health and the status of their cancer. After the treatment period, patients will have follow-up visits every three months for two years, and then every six months, to track their progress and overall survival. These follow-ups can be done over the phone, in person, or by reviewing medical records. The study will end two years after the last patient joins.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with stage III ovarian cancer, including related cancers like primary peritoneal or fallopian-tube cancer.
  • Have had surgery to remove most of the cancer, with less than 1 cm of tumor remaining.
  • Can start additional therapy within six weeks after surgery.
  • Have a specific type of tumor that is proficient in homologous recombination, as confirmed by FDA-approved tests.
  • Be in good overall health, with an ECOG performance status of 0 or 1.
  • Have adequate organ function.

Exclusion Criteria

  • Have a known allergy or reaction to rhuGM-CSF.
  • Have had another active cancer within the last five years, except for certain skin cancers or other cancers that have been treated and show no signs of disease.
  • Are currently on or have recently been on immune suppression therapy.
  • Have an active or past autoimmune or inflammatory disease.
  • Have an active infectious disease, such as tuberculosis, hepatitis B or C, or HIV.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

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