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The study was terminated due to emergent data from another study and unrelated to safety.
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The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCAGN01876 + Pembrolizumab + Epacadostat | Experimental | INCAGN01876 in combination with pembrolizumab and epacadostat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCAGN01876 | Drug | In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment. | Screening through 60 days after end of treatment, up to approximately 18 months |
| Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
| Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 | Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1 | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months. |
| Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John N. Janik, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | United States | ||
| Hackensack University Medical Center |
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A total of 10 participants were screened and enrolled in the study.
The study was conducted at 2 different sites in USA. A total of 10 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | INCAGN01876 + Pembrolizumab + Epacadostat | INCAGN01876 in combination with pembrolizumab and epacadostat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
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| ID | Title | Description |
|---|---|---|
| BG000 | INCAGN01876 + Pembrolizumab + Epacadostat | INCAGN01876 in combination with pembrolizumab and epacadostat |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Count of Participants | Participants | Screening through 60 days after end of treatment, up to approximately 18 months |
|
|
up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2017 | Jul 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2018 | Jul 1, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D008545 | Melanoma |
| D015266 | Carcinoma, Merkel Cell |
| D008654 | Mesothelioma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D055752 | Small Cell Lung Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| D064726 | Triple Negative Breast Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000613752 | epacadostat |
| C582435 | pembrolizumab |
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|
| Epacadostat | Drug | Epacadostat will be self-administered orally at the protocol-defined dose. |
|
|
| Pembrolizumab | Drug | Pembrolizumab will be administered IV at the protocol-defined dose. |
|
|
Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause. |
| Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
| Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | Defined as time from first report of SD or better until disease progression or death from any cause. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
| Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause. | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
| Phase 1 & Phase 2: Overall Survival | Defined as the time from the start of combination therapy until death due to any cause. | At 1 year and 2 years. |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Count of Participants | Participants | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
|
|
|
| Primary | Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 | Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1 | The study was terminated early and no participants enrolled in Phase 2 of the study. | Posted | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
|
|
| Secondary | Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Count of Participants | Participants | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months. |
|
|
|
| Secondary | Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Median | 95% Confidence Interval | days | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
|
|
|
| Secondary | Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | Defined as time from first report of SD or better until disease progression or death from any cause. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Median | 95% Confidence Interval | days | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
|
|
|
| Secondary | Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Median | 95% Confidence Interval | months | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months |
|
|
|
| Secondary | Phase 1 & Phase 2: Overall Survival | Defined as the time from the start of combination therapy until death due to any cause. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Posted | Median | 95% Confidence Interval | months | At 1 year and 2 years. |
|
|
|
| 4 |
| 10 |
| 3 |
| 10 |
| 10 |
| 10 |
| EG001 | Total | Total | 4 | 10 | 3 | 10 | 10 | 10 |
| Colitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 20 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 20 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 20 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 20 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 20 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20 | Systematic Assessment |
|
| Hydrogen breath test abnormal | Investigations | MedDRA 20 | Systematic Assessment |
|
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 20 | Systematic Assessment |
|
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 20 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 20 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 20 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 20 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20 | Systematic Assessment |
|
Clinical Study Agreement
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002294 | Carcinoma, Squamous Cell |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |