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

Incyte

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Metastatic Cancer

Advanced Malignancies

Treatments

Drug: Pembrolizumab

Drug: Epacadostat

Drug: INCAGN01876

Study type

Interventional

Funder types

Industry

Identifiers

INCAGN 1876-202

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
Phase 1: Subjects with advanced or metastatic solid tumors.
Phase 1: Subjects who have disease progression after treatment with available therapies.
Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma.
Presence of measurable disease based on RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion criteria

Laboratory and medical history parameters not within the Protocol-defined range
Prior treatment with any tumor necrosis factor super family agonist.
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
Active autoimmune disease.
Known active central nervous system metastases and/or carcinomatous meningitis.
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).