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

NCT05794659 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-07-20

No results posted yet for this study

Summary

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).

Conditions

  • Advanced Ovarian Cancer

Interventions

BIOLOGICAL

AST-201

i.d. (3-week interval, 3 cycles in total)

DRUG

Paclitaxel

3-week interval, 6 cycles in total

DRUG

Carboplatin

3-week interval, 6 cycles in total

DRUG

Placebo

i.d. (3-week interval, 3 cycles in total)

DRUG

rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)

i.d. (3-week interval, 3 cycles in total)

Sponsors & Collaborators

  • Aston Sci. Inc.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-11-15
Completion
2027-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05794659 on ClinicalTrials.gov