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

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

NCT ID: NCT05794659

Condition: Advanced Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Paclitaxel
Carboplatin
Molgramostim
Sargramostim

Conditions: Keywords:
cancer vaccine
phase 2 study
Advanced ovarian cancer
homologous-recombination proficient (HRP)

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study

Primary purpose: Treatment

Masking: Single (Participant)

Masking description: Single blinded

Intervention:

Intervention type: Biological
Intervention name: AST-201
Description: i.d. (3-week interval, 3 cycles in total)
Arm group label: AST-301

Other name: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

Intervention type: Drug
Intervention name: Paclitaxel
Description: 3-week interval, 6 cycles in total
Arm group label: AST-301
Arm group label: Placebo

Other name: Taxol

Intervention type: Drug
Intervention name: Carboplatin
Description: 3-week interval, 6 cycles in total
Arm group label: AST-301
Arm group label: Placebo

Other name: Paraplatin

Intervention type: Drug
Intervention name: Placebo
Description: i.d. (3-week interval, 3 cycles in total)
Arm group label: Placebo

Other name: Normal saline (USP)

Intervention type: Drug
Intervention name: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
Description: i.d. (3-week interval, 3 cycles in total)
Arm group label: AST-301
Arm group label: Placebo

Other name: sargramostim

Other name: Leukine

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Washington

Address:
City: Seattle
Zip: 98109
Country: United States

Contact:
Last name: John B. Liao, MD, PhD

Start date: November 15, 2023

Completion date: November 15, 2027

Lead sponsor:
Agency: Aston Sci. Inc.
Agency class: Industry

Source: Aston Sci. Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05794659