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)

PN-201-22

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).

2023-11-15

2025-11-15

2027-11-15

Not yet recruiting

Early phase I

98

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single blinded', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 98, 'type': 'ESTIMATED'}}

2023-07-20