Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone4)

Aston Sci.

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Ovarian Cancer

Treatments: Drug: Carboplatin; Drug: Placebo; Biological: AST-201; Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor); Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05794659

PN-201-22

Details and patient eligibility

About

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).

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups, including a placebo group

AST-301

Experimental group

Description:

AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \* Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Treatment:

Drug: Paclitaxel

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

Biological: AST-201

Drug: Carboplatin

Placebo

Placebo Comparator group

Description:

Placebo with rhuGM-CSF (3-week interval, 3 cycles in total) Standard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total) \*Both AST-201/rhuGM-CSF or Placebo/rhuGM-CSF will be given intradermally 2 weeks after each combination chemotherapy (on Day 15 of each cycle) for 3 cycles

Treatment:

Drug: Paclitaxel

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

Drug: Placebo

Drug: Carboplatin