Clinical trial · Interventional
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AST-201 | Biological | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AST-301
- 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
- interventionNames
- Biological: AST-201
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- 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
- interventionNames
- Drug: Paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available