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Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Hematologic Diseases

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Nivolumab

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Lysine

Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups:

* Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML.
* Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML
* Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment.

Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s).

Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.

INCB059872 tablets to be administered by mouth.

INCB059872

all-trans retinoic acid (ATRA)

azacitidine

nivolumab

Fred Zheng, MD

This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.

An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.

ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10\^9/Liter (L), platelet count ≥100 x 10\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \< 1.0 x 10\^9/L and/or the platelet count may be \<100 x 10\^9/L.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10\^9/L, platelets ≥100 x 10\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.

Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.

Cmax was defined as the maximum observed plasma concentration of INCB059872.

tmax was defined as the time to the maximum observed plasma concentration of INCB059872.

AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.

t1/2 was defined as the half-life of INCB059872.

CL/F was defined as the apparent oral clearance of INCB059872.

ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10\^9/L, platelet count ≥100 x 10\^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be \< 1.0 x 10\^9/L and/or the platelet count may be \<100 x 10\^9/L.

ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: \<5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10\^9/L, platelets ≥100 x 10\^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.

Incyte Corporation

Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.

Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 2 mg QOD

Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 2 mg QD

Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 3 mg QOD

Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 3 mg QD

Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 4 mg QD

Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group A: INCB059872 Monotherapy; 5 mg QD

Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 1 mg QD

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 2 mg QOD

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 2 mg QD

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 3 mg QOD

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 3 mg QD

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Group B: INCB059872 Monotherapy; 4 mg QOD

Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.

Group C: Combination Therapy; INCB059872 2 mg QD + ATRA

Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.

Group C: Combination Therapy; INCB059872 3 mg QD + ATRA

Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m\^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.

Group C: Combination Therapy; INCB059872 4 mg QD + ATRA

Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.

Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine

Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m\^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.

Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine

Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.

Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab

Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.

Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.

Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.

Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared \[m\^2\] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.

Total

Age, Continuous

For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

American-Indian/Alaska Native

Non-White

Unknown/Not Specified

Declined to Report

Race/Ethnicity, Customized

The study was terminated by the sponsor due to a strategic business decision.

Study Director

Safety Population: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab

Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)

Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE

SCLC

Ewing's sarcoma

Poorly differentiated neuroendocrine tumors

Other solid tumors

Full Analysis Set: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab. Only participants with the indicated type of solid tumor who received monotherapy were analyzed.

Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy

Full Analysis Set. Only participants with AML who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.

ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy

Full Analysis Set. Only participants with MDS who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.

ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy

Full Analysis Set. Analysis was not conducted because no participants with MF remained in the study at Week 12.

Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy

Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose PK sample

Cmax of INCB059872 in Plasma When Received as Monotherapy

Pharmacokinetic (PK)-Evaluable Population

Tmax of INCB059872 in Plasma When Received as Monotherapy

Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.

AUC(0-τ) of INCB059872 in Plasma When Received as Monotherapy

t1/2 of INCB059872 in Plasma When Received as Monotherapy

CL/F of INCB059872 in Plasma When Received as Monotherapy

Full Analysis Set. Only participants with SCLC who received combination therapy and had available data were analyzed.

ORR in Participants With SCLC Who Received Combination Therapy

Full Analysis Set. Only participants with AML who received combination therapy were analyzed.

ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy

Full Analysis Set. Only participants with MDS who received combination therapy were analyzed.

ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy

Cmax of INCB059872 in Plasma When Received as Combination Therapy

Tmax of INCB059872 in Plasma When Received as Combination Therapy

AUC(0-τ) of INCB059872 in Plasma When Received as Combination Therapy

t1/2 of INCB059872 in Plasma When Received as Combination Therapy

CL/F of INCB059872 in Plasma When Received as Combination Therapy

Monotherapy

Combination Therapy

Skin and Connective Tissue Diseases

Sarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria. Part 2: Expansion with the recommended dose from Part 1.

The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.

A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma

Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related.

Defined as the percentage of participants who have a complete response or partial response as determined by investigator assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Defined as maximum observed plasma concentration.

Defined as time to maximum concentration.

Defined as apparent terminal-phase disposition half-life.

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Neoplastic Processes

Pembrolizumab

INCB057643

Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.

Part 1 is an open-label 3 + 3 + 3 dose-escalation design based on observing each dose level for a period of 42 days. Part 1 will also contain dose-expansion cohorts in previously treated NSCLC and MSS CRC. Part 2 will evaluate the recommended dose determined in Part 1.

Five doses of azacitidine will be administered by subcutaneous injection or intravenously (IV) over Days 1 to 7 in Cycles 1 through 6.

Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks on Day 1 of each 21-day cycle.

Epacadostat tablets will be administered orally twice daily.

Epacadostat

INCB057643 will be orally self- administered once daily beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.

Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks of each 21-day cycle starting on Cycle 2 Day 1.

Epacadostat tablets will be administered orally twice daily starting at Cycle 2 Day 1.

INCB059872 will be orally self- administered once daily OR every other day beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.

Kevin O'Hayer, MD

This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination. Treatment Group A will evaluate the DNA methyltransferase inhibitor azacitidine in combination with the programmed death receptor-1 (PD-1) inhibitor pembrolizumab and the indoleamine 2,3-dioxygenase (IDO-1) inhibitor epacadostat; Treatment Group B will evaluate the bromodomain and extra-terminal (BET) inhibitor INCB057643 with pembrolizumab and epacadostat; and Treatment Group C will evaluate the lysine-specific demethylase 1A (LSD1) inhibitor INCB059872 with pembrolizumab and epacadostat. The study will be divided into 2 parts (Part 1 and 2). Part 1 is a dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. Once the recommended doses have been determined, subjects with previously treated NSCLC, microsatellite-stable colorectal cancer (CRC), head and neck squamous cell carcinoma, urothelial carcinoma, and melanoma will be enrolled into expansion cohorts in Part 2.

Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer (ECHO-206)

A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

ORR was defined as the percentage of participants having a 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. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies	NCT02712905	Solid Tumors an...	INCB059872 all-trans retin... azacitidine nivolumab	18 Years -	Incyte Corporation
A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma	NCT03514407	Relapsed Ewing ...	INCB059872	12 Years -	Incyte Corporation
Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)	NCT02959437	Solid Tumors Advanced Malign... Metastatic Canc...	Azacitidine Pembrolizumab Epacadostat INCB057643 Pembrolizumab Epacadostat INCB059872	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for incb059872

Every month we try and update this database with for incb059872 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incb059872

Every month we try and update this database with for incb059872 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incb059872 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.