A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Advanced Malignancies

In brief

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Key facts

Study ID

NCT03241173

Run by

Incyte Biosciences International Sàrl

People needed

52

Starts

2017-10-09

Expected to finish

2019-09-17

Last updated by the study team

2022-09-27

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 gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
• Presence of measurable disease based on RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

You may not qualify if…

• Laboratory and medical history parameters not within the Protocol-defined range
• 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 University of Alabama Birmingham (UAB) — Birmingham, Alabama, United States
• Scottsdale Healthcare Hospitals DBA HonorHealth — Scottsdale, Arizona, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• Mount Sinai Medical Center of Florida, Inc. — Miami, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• John Theurer Cancer Center At Hackensack UMC — Hackensack, New Jersey, United States
• Rutgers, The State University — New Brunswick, New Jersey, United States
• New York University Clinical Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute, LLC (SCRI) — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.