Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06157151
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an open-label, randomized study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.', 'timeFrame': '1 year', 'description': 'The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1.\n\nORR will be calculated and presented with 2-sided 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Safety of PRGN-2009 in combination with pembrolizumab or pembrolizumab alone', 'timeFrame': '1 year', 'description': 'Systemic toxicity will be assessed through the capture of Treatment Emergent Adverse Events ( TEAEs). The severity of the TEAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 scale.'}, {'measure': 'Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone', 'timeFrame': '1 year', 'description': 'Duration of PFS and OS will be summarized using the Kaplan-Meier Product Limit estimator along with the corresponding two sided-95% Confidence intervals.'}, {'measure': 'Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone', 'timeFrame': '1 year', 'description': 'The proportion of subjects with BOR and DCR will be summarized using descriptive statistics.'}, {'measure': 'Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone', 'timeFrame': '1 year', 'description': 'TTR and DOR will be summarized using descriptive statistics.'}, {'measure': 'Vector shedding following subcutaneous administration of PRGN-2009', 'timeFrame': 'Up to 4 months', 'description': 'Samples collected before and at specific intervals after treatment will be evaluated for presence of adenoviral vector.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Papilloma Virus', 'Cervical Cancer', 'Pembrolizumab', 'Therapeutic Vaccine', 'Cervix Cancer', 'Resistance to Checkpoint Inhibitors'], 'conditions': ['Cervical Cancer', 'HPV-Related Carcinoma', 'HPV-Related Malignancy', 'Recurrent Cervical Carcinoma', 'Metastatic Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.', 'detailedDescription': 'This is a randomized, two-arm study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of PRGN-2009, plus pembrolizumab, or to receive pembrolizumab alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older.\n* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.\n* Must have been treated with pembrolizumab, either as monotherapy or in combination\n* Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting\n* Tumors are confirmed positive for PD-L1 and HPV16/18\n* Measurable disease that can be accurately measured by RECIST v1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks from the time of enrollment.\n* Must have adequate organ function\n* Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.\n* All patients must have the ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients with presence of other active malignancy within 1 year prior to study entry\n* Known Central Nervous System (CNS) disease\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.\n* Known history of active tuberculosis (TB, Bacillus tuberculosis).\n* Pregnant and lactating women are excluded from this study.\n* Patients with a history of solid organ transplant.\n* Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.'}, 'identificationModule': {'nctId': 'NCT06157151', 'briefTitle': 'PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Precigen, Inc'}, 'officialTitle': 'A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy in Patients With Recurrent or Metastatic Cervical Cancer.', 'orgStudyIdInfo': {'id': 'PRGN-2009-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRGN-2009 plus Pembrolizumab', 'description': 'PRGN-2009 at a dose of 5 x 10\\^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w', 'interventionNames': ['Biological: PRGN-2009 plus Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab alone', 'description': 'Pembrolizumab, 400mg q6w', 'interventionNames': ['Drug: Pembrolizumab alone']}], 'interventions': [{'name': 'PRGN-2009 plus Pembrolizumab', 'type': 'BIOLOGICAL', 'description': 'Subjects randomized will receive PRGN-2009 (5 x 10\\^11 PU, subcutaneous (SC) injection) every 3 weeks for three administrations, thereafter subjects will continue to receive PRGN-2009 administrations every 6 weeks. Pembrolizumab will be administered concurrently as intravenous (IV) infusion (400 mg) every 6 weeks.', 'armGroupLabels': ['PRGN-2009 plus Pembrolizumab']}, {'name': 'Pembrolizumab alone', 'type': 'DRUG', 'description': 'Subjects randomized will receive IV infusion of pembrolizumab (400 mg) administered every 6 weeks.', 'armGroupLabels': ['Pembrolizumab alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nou Yang', 'role': 'CONTACT', 'email': 'nyang@uams.edu', 'phone': '501-320-7749'}, {'name': 'Michael Birrer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shannon Householder', 'role': 'CONTACT', 'email': 'shannon.householder@nih.gov'}], 'facility': 'National Institute of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Liao, MD', 'role': 'CONTACT', 'email': 'cvitrial@uw.edu', 'phone': '866-932-8588'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Amy Lankford', 'role': 'CONTACT', 'email': 'clinicaltrials@precigen.com', 'phone': '3015569900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Precigen, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}