Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.

INCB024360

Lance Leopold, MD

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

A Dose-escalation Study in Subjects With Advanced Malignancies

A Phase I, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of INCB024360 in Patients With Advanced Malignancies

Incyte Corporation

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Melanoma

Stomach Neoplasms

Head and Neck Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Urinary Bladder Neoplasms

Microsatellite Instability

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Adenocarcinoma

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Kidney Neoplasms

Kidney Diseases

Uterine Neoplasms

Uterine Diseases

Breast Diseases

Genomic Instability

Ovarian Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Phase 1: MK-3475 + INCB024360 25 mg twice a day (BID) as starting dose, followed by dose escalations (Phase 1) until recommended phase 2 dose of INCB024360 is determined

MK-3475

Mark Jones, MD

The purpose of this study was to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in participants with certain cancers. This study was conducted in 2 phases, Phase 1 and Phase 2.

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)

An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.

ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.

Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.

The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.

Overall survival is determined from the date of first dose until death due to any cause.

Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1

Merck Sharp & Dohme LLC

The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 25 mg BID

Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 50 MG BID

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1

Phase 1: Epacadostat 100 MG BID

Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1

Phase 1: Epacadostat 300 MG BID

Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).

Phase 2: Epacadostat 100 MG BID

Total

Phase 1: Epacadostat 50 mg BID

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 100 mg BID

Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 300 mg BID

Phase 2: Epacadostat 100 mg BID

Age, Continuous

Sex: Female, Male

White/Caucasian

Black/African-American

Asian

Native Hawaiian/Pacific Islander

Other

Missing

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Unknown

Study enrollment was permanently discontinued on 17 May 2018 as a strategic decision.

Study Director

TEAS

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events

Triple negative breast cancer

Microsatellite-instability high colorectal cancer

Gastric cancer

Hepatocellular carcinoma

Melanoma - immune checkpoint-naïve

Non-small cell lung cancer (NSCLC) (tumor proportion score (TPS) < 50% or indeterminate)

NSCLC programmed cell death ligand (PD-L1) low negative (TPS < 50%)

Ovarian cancer

Renal cell carcinoma

Squamous cell carcinoma of the head and neck

Transitional carcinoma of the genitourinary (GU) tract

Diffuse large B-cell lymphoma

Primary Refractory Melanoma

Relapsed Melanoma

Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W

The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.

Phase 2: Objective Response Rate (ORR)

Hepatocellular Carcinoma

Triple Negative Breast Cancer

Immune Checkpoint-naïve Melanoma

NSCLC high positive (PD-L1 TPS ≥ 50%)

NSCLC low/negative or indeterminate (PD-L1 TPS < 50% or indeterminate)

NSCLC (TPS 0%)

NSCLC Unknown

Squamous Cell Carcinoma of the Head and Neck

Transitional Cell Carcinoma of the GU Tract

Gastric Cancer

MSI high Colorectal Cancer

DLBCL

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Number analyzed indicated participants analyzed in the respective tumor type and those who responded.

Phase 2: Duration of Response (DOR)

NSCLC

The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Number analyzed indicated participants analyzed in the respective tumor type.

Phase 2: Progression Free Survival (PFS)

NSCLC Total

The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.

Phase 2: Duration of Disease Control

The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.

Phase 2: Overall Survival (OS)

The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.

Phase 2: Ordinal Categorical Response Score

Treatment-Emergent Adverse Events (TEAE)

Serious Treatment-Emergent Adverse Events

The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Treatment groups for this population were determined according to the actual treatment the participant receives on Day 1. All safety analyses were conducted using the safety evaluable population.

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events

Overall Study

Recurrence

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Cancer

Antirheumatic Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Interleukin-2

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Analgesics, Non-Narcotic

Haploidentical donor NK cells and IL-2 are infused intraperitoneally (IP) after a non-myeloablative preparative regimen of cyclophosphamide and fludarabine. INCB024360, at the assigned dose, begins 2 days before the NK cell infusion and continues twice daily for 90 days.

Fludarabine 25 mg/m\^2 IV on days -6 through -2 from NK cell infusion

Cyclophosphamide 30 mg/kg IV on days -5 and -4 from NK cell infusion

CD3-/CD19- selected NK cells administered by intraperitoneal (IP) infusion on day 0

NK cells

IL-2 at 6 million units/dose IP 3 times a week x 6 doses with the 1st dose given immediately after the NK cell infusion

IL-2

INCB024360 at assigned dose by mouth twice a day begin day -2 and continue for 90 days (+/- 3 days)

Melissa Geller, MD

This is a single center phase I trial designed to determine the maximum tolerated dose (MTD) of the oral IDO inhibitor INCB024360 when administered as part of a larger regimen of intraperitoneal (IP) delivery of haploidentical donor NK cells and IL-2 after a non-myeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen for the treatment of recurrent ovarian, fallopian tube, and primary peritoneal cancer.

Haploidentical donor NK cells and the 1st dose of IL-2 are infused intraperitoneally (IP) after a non-myeloablative preparative regimen of cyclophosphamide and fludarabine. IP IL-2 continues three times a week for 5 additional doses. INCB024360, at the assigned dose, begins 2 days before the NK cell infusion (on day -2) and continues twice daily for 90 days.

Follow-up for disease response and survival is for 1 year from the NK cell infusion with the possibility of re-treatment for patients who experience at least a clinical benefit for a minimum of 6 months prior to disease progression.

The MTD of INCB024360 will be determined using the continual reassessment method (CRM). The 1st 2 patients will be enrolled at dose level 1 (50 mg bid) of INCB024360. Each new cohort of 2 patients will be sequentially assigned to most appropriate dose by the study statistician based on the updated toxicity profile. Up to 4 dose levels of INCB024360 will be tested (50, 100, 200, and 300 mg bid) with a dose level -1 (25 mg bid) used in the event that 50 mg bid proves to be too toxic. The MTD will be identified when the total sample size of 20 patients is exhausted.

Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Indoleamine-2,3-dioxygenase (IDO) Inhibition With INCB024360 and Intraperitoneal Delivery of Allogeneic Natural Killer Cells for Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

To determine the maximum tolerated dose (MTD) of INCB024360 when administered with intraperitoneal haploidentical donor NK cells/IL-2 after a nonmyeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose-escalation Study in Subjects With Advanced Malignancies	NCT01195311	Solid Tumors an...	INCB024360	18 Years -	Incyte Corporation
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers	NCT02178722	Microsatellite-... Endometrial Can... Head and Neck C... Hepatocellular ... Gastric Cancer Lung Cancer Lymphoma Renal Cell Carc... Ovarian Cancer Solid Tumors UC (Urothelial ... Melanoma Bladder Cancer Triple Negative...	MK-3475 INCB024360	18 Years -	Incyte Corporation
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers	NCT02178722	Microsatellite-... Endometrial Can... Head and Neck C... Hepatocellular ... Gastric Cancer Lung Cancer Lymphoma Renal Cell Carc... Ovarian Cancer Solid Tumors UC (Urothelial ... Melanoma Bladder Cancer Triple Negative...	MK-3475 INCB024360	18 Years -	Incyte Corporation
Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer	NCT02118285	Ovarian Cancer Fallopian Tube ... Primary Periton...	Fludarabine Cyclophosphamid... NK cells IL-2 INCB024360	18 Years -	Masonic Cancer Center, University of Minnesota
Phase II INCB024360 Study for Patients With Myelodysplastic Syndromes (MDS)	NCT01822691	Myelodysplastic...	INCB024360	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)	NCT02318277	Solid Tumors Head and Neck C... Lung Cancer UC (Urothelial ...	MEDI4736 INCB024360	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for incb024360

Every month we try and update this database with for incb024360 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 incb024360

Every month we try and update this database with for incb024360 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 incb024360 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.