Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 5:15 PM
Study NCT ID:
NCT05909995
Status:
TERMINATED
Last Update Posted:
2025-02-18
First Post:
2023-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Mexico', 'Norway', 'Slovakia', 'South Korea', 'Sweden', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'C536928', 'term': 'Turcot syndrome'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'This was a strategic business decision. There were no safety concerns contributing to this decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of DLTs', 'timeFrame': '2 Years'}, {'measure': 'Incidence of TEAEs', 'timeFrame': '2 Years', 'description': 'Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.'}, {'measure': 'Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs', 'timeFrame': '2 Years'}], 'secondaryOutcomes': [{'measure': 'Concentration of INCB099280 in plasma', 'timeFrame': '2 Years'}, {'measure': 'Objective response', 'timeFrame': '2 Years', 'description': 'Defined as having a best overall response of complete response or partial response by investigator assessment per RECIST v1.1.'}, {'measure': 'Disease control', 'timeFrame': '2 Years', 'description': 'Defined as having a best overall response of complete response or partial response, or stable disease of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1.'}, {'measure': 'Duration of Response', 'timeFrame': '2 Years', 'description': 'Defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma', 'Hepatocellular Carcinoma (HCC)', 'Renal Cell Carcinoma (RCC)', 'Microsatellite Instability - High (MSI-H)', 'Mismatch Repair Deficient (dMMR)', 'Colorectal Carcinoma (CRC)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior systemic therapy, diagnoses and disease setting as follows:\n\n * For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following,\n\n * Unresectable or metastatic cutaneous melanoma, or\n * Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or\n * Intermediate or poor-risk advanced clear cell RCC, or\n * MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.\n * For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following,\n\n * Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or\n * Intermediate - or poor-risk advanced clear cell RCC.\n * ECOG performance score of 0 or 1.\n * Life expectancy \\> 3 months, in the opinion of the investigator.\n * Histologically confirmed solid tumors with measurable disease per RECIST v1.1.\n\n * Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria.\n * Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Known history of an additional malignancy.\n* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.\n* Toxicity from prior therapy that has not recovered.\n* Received thoracic radiation within 6 months of the first dose of study treatment.\n* Participation in another interventional clinical study while receiving INCB099280.\n* Impaired cardiac function of clinically significant cardiac disease.\n* History of evidence of interstitial lung disease including non-infections pneumonitis.\n* Presence of gastrointestinal condition that may affect drug absorption\n* Any autoimmune disease requiring systemic treatment in the past 5 years.\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent\n* Active infection requiring systemic therapy.\n* History of organ transplantation, including allogeneic stem cell transplantation.\n* Receipt of system antibiotics within 28 days of first dose of study treatment.\n* Probiotic usage is prohibited during the screening and throughout the study treatment period.\n* Received a live vaccine within 28 days of planned start of study drug.\n* Laboratory values outside the Protocol-defined ranges.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05909995', 'briefTitle': 'Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors', 'orgStudyIdInfo': {'id': 'INCB 99280-205'}, 'secondaryIdInfos': [{'id': '2023-503243-34-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': '* Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks\n* Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks', 'interventionNames': ['Drug: INCB 99280 with Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': '* Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab\n* Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab', 'interventionNames': ['Drug: INCB 99280 with Ipilimumab']}], 'interventions': [{'name': 'INCB 99280 with Ipilimumab', 'type': 'DRUG', 'description': 'Dose Escalation and expansion of INCB 99280 with Ipilimumab', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Valkyrie Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alliance For Multispecialty Research Llc', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '01692', 'city': 'Centurion', 'country': 'South Africa', 'facility': 'Johese Clinical Research: Midstream', 'geoPoint': {'lat': -25.85891, 'lon': 28.18577}}, {'zip': '00181', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Mary Potter Oncology Centre', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}