Clinical trial NCT05794659: Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Ovarian Cancer
Keywords: cancer vaccine
phase 2 study
Advanced ovarian cancer
homologous-recombination proficient (HRP)
Lead sponsor: Aston Sci. Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: overall study duration (approximately 48 months)
Secondary outcomes:
measure: 2-year PFS rate
timeFrame: 24months from the first dose of AST-301 administration
measure: Overall Survival (OS)
timeFrame: overall study duration (approximately 48 months)
measure: AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )
timeFrame: 17months
measure: Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)
timeFrame: 5 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: hyunwon.shin@astonsci.com
name: Hyunwon Shin, MD, PhD
role: STUDY_DIRECTOR
References: