Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Infections

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Stomach Neoplasms

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Neoplasm Metastasis

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Necrosis

Microsatellite Instability

Mesothelioma

Mesothelioma, Malignant

Carcinoma, Merkel Cell

Esophageal Cancer

Small Cell Lung Cancer

Ovarian Cancer

Transitional Cell Carcinoma

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Merkel Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Glucocorticoids

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

INCAGN01876 in combination with pembrolizumab and epacadostat

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.

INCAGN01876

Epacadostat will be self-administered orally at the protocol-defined dose.

Epacadostat

Pembrolizumab will be administered IV at the protocol-defined dose.

John N. Janik, MD

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

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.

Defined as the percentage of participants having a CR or PR based on investigator assessment per 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

Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.

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.

Defined as time from first report of SD or better until disease progression or death from any cause.

Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.

Defined as the time from the start of combination therapy until death due to any cause.

Incyte Biosciences International Sàrl

INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID

Total

INCAGN01876 + Pembrolizumab + Epacadostat

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.

Study Director

The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.

Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST

The study was terminated early and no participants enrolled in Phase 2 of the study.

Spots Global Cancer Trial Database for INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial