Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 11:41 AM
Study NCT ID:
NCT05794659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'C081222', 'term': 'sargramostim'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind, randomized, placebo-controlled, multicenter, phase 2 clinical study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'overall study duration (approximately 48 months)', 'description': 'the time from the date of randomization to disease progression, or death from any cause whichever occurs first'}], 'secondaryOutcomes': [{'measure': '2-year PFS rate', 'timeFrame': '24months from the first dose of AST-301 administration', 'description': 'proportion of patients alive without disease progression or death at two years after the randomization'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'overall study duration (approximately 48 months)', 'description': 'the time from the date of randomization to death from any cause'}, {'measure': 'AST-201 specific immunogenicity by Interferon gamma (IFN-gamma) enzyme-linked immunospot (ELISpot )', 'timeFrame': '17months', 'description': 'AST-201 specific IFN-gamma ELISpot'}, {'measure': 'Number of participants with Adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0)', 'timeFrame': '5 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer vaccine', 'phase 2 study', 'Advanced ovarian cancer', 'homologous-recombination proficient (HRP)'], 'conditions': ['Advanced Ovarian Cancer']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer\n* Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)\n* Can start adjuvant therapy within 6 weeks of debulking surgery\n* Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhuGM-CSF\n* 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\n* Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs\n* Has active or prior autoimmune disease or inflammatory disease\n* Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study'}, 'identificationModule': {'nctId': 'NCT05794659', 'acronym': 'Cornerstone4', 'briefTitle': 'Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aston Sci. Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'PN-201-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AST-301', 'description': 'AST-201 with rhuGM-CSF (3-week interval, 3 cycles in total)\n\nStandard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)\n\n\\* 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)\n\nStandard chemotherapy (paclitaxel/carboplatin) (3-week interval, 6 cycles in total)\n\n\\*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', 'Drug: Carboplatin', 'Drug: Placebo', 'Drug: rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)']}], 'interventions': [{'name': 'AST-201', 'type': 'BIOLOGICAL', 'otherNames': ['pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine'], 'description': 'i.d. (3-week interval, 3 cycles in total)', 'armGroupLabels': ['AST-301']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '3-week interval, 6 cycles in total', 'armGroupLabels': ['AST-301', 'Placebo']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': '3-week interval, 6 cycles in total', 'armGroupLabels': ['AST-301', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline (USP)'], 'description': 'i.d. (3-week interval, 3 cycles in total)', 'armGroupLabels': ['Placebo']}, {'name': 'rhuGM-CSF(Granulocyte-Macrophage Colony-Stimulating Factor)', 'type': 'DRUG', 'otherNames': ['sargramostim', 'Leukine'], 'description': 'i.d. (3-week interval, 3 cycles in total)', 'armGroupLabels': ['AST-301', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'contacts': [{'name': 'John B. Liao, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Hyunwon Shin, MD, PhD', 'role': 'CONTACT', 'email': 'hyunwon.shin@astonsci.com', 'phone': '+82-2-2038-2347'}, {'name': 'Eunkyo Joung, MD, CMO', 'role': 'CONTACT', 'email': 'eunkyo.joung@astonsci.com', 'phone': '+82-2-2038-2347'}], 'overallOfficials': [{'name': 'Hyunwon Shin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'hyunwon.shin@astonsci.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aston Sci. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}