Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT03589651
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2018-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613752', 'term': 'epacadostat'}, {'id': 'C000656179', 'term': 'parsaclisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment-emergent adverse events', 'timeFrame': 'Up to approximately 30 months', 'description': 'Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Cmax of INCMGA00012 when given in combination with immune therapies', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Tmax of INCMGA00012 when given in combination with immune therapies', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Cmax of epacadostat when given in combination with INCMGA00012', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Tmax of epacadostat when given in combination with INCMGA00012', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Cmax of INCB050645 when given in combination with INCMGA00012', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Tmax of INCB050645 when given in combination with INCMGA00012', 'timeFrame': 'Up to approximately 4 months', 'description': 'Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated.'}, {'measure': 'Overall response rate', 'timeFrame': 'Up to approximately 30 months', 'description': 'Defined as the percentage of participants having complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST v1.1 for immune-based therapeutics.'}, {'measure': 'Duration of response', 'timeFrame': 'Up to approximately 30 months', 'description': 'Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to approximately 30 months', 'description': 'Defined as the time from the start of therapy until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to approximately 30 months', 'description': 'Defined as the time from randomization to death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid tumors', 'locally advanced unresectable tumor', 'metastatic solid tumors'], 'conditions': ['Unresectable or Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy\n* Measurable or nonmeasurable tumor lesions per RECIST v 1.1.\n* Willing to provide fresh or archival tumor tissue for correlative studies.\n* Eastern Cooperative Oncology Group performance status 0 to 1.\n* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.\n\nExclusion Criteria:\n\n* Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.\n* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).\n* Laboratory values outside the protocol-defined range at screening.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.\n* Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).\n* Evidence of interstitial lung disease or active, noninfectious pneumonitis.'}, 'identificationModule': {'nctId': 'NCT03589651', 'briefTitle': 'INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'INCMGA 0012-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'INCMGA00012 with epacadostat.', 'interventionNames': ['Drug: Retifanlimab', 'Drug: Epacadostat']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'INCMGA00012 with INCB050465.', 'interventionNames': ['Drug: Retifanlimab', 'Drug: INCB050465']}], 'interventions': [{'name': 'Retifanlimab', 'type': 'DRUG', 'description': 'Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose.\n\nPart 2: INCMGA00012 at the recommended dose from Part 1.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Epacadostat', 'type': 'DRUG', 'otherNames': ['INCB024360', 'INCMGA00012'], 'description': 'Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose.\n\nPart 2: Epacadostat at the recommended dose from Part 1.', 'armGroupLabels': ['Group A']}, {'name': 'INCB050465', 'type': 'DRUG', 'description': 'Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of Nj', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Upmc Cancercenter', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}