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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Malignancies, Metastatic Cancer

In brief

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

Key facts

Study ID

NCT03277352

Run by

Incyte Biosciences International Sàrl

People needed

10

Starts

2017-11-21

Expected to finish

2020-07-01

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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