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

Advanced Ovarian Cancer Clinical Trial

— Cornerstone4  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05794659
• Other study ID #: PN-201-22
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 15, 2023
• Est. completion date: November 15, 2027

Study information

• Verified date: July 2023
• Source: Aston Sci. Inc.
• Contact: Hyunwon Shin, MD, PhD
• Phone: +82-2-2038-2347
• Email: hyunwon.shin[@]astonsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: November 15, 2027
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Biological:
• AST-201
i.d. (3-week interval, 3 cycles in total)

Drug:
• Paclitaxel
3-week interval, 6 cycles in total
• Carboplatin
3-week interval, 6 cycles in total
• Placebo
i.d. (3-week interval, 3 cycles in total)
• rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
i.d. (3-week interval, 3 cycles in total)

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Aston Sci. Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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	2-year PFS rate	proportion of patients alive without disease progression or death at two years after the randomization	24months from the first dose of AST-301 administration
Secondary	Overall Survival (OS)	the time from the date of randomization to death from any cause	overall study duration (approximately 48 months)
Secondary	AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )	AST-201 specific IFN-gamma ELISpot	17months
Secondary	Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)	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