Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

Completed · 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 in subjects with advanced or metastatic malignancies.

Key facts

Study ID

NCT03126110

Run by

Incyte Biosciences International Sàrl

People needed

145

Starts

2017-04-25

Expected to finish

2021-11-09

Last updated by the study team

2025-08-14

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 cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
• 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
• 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
• University of Florida — Gainesville, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University - Siteman Cancer Center — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer — New York, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Oklahoma, Sarah Cannon Research Institute — Oklahoma City, Oklahoma, United States
• Providance Portland Medical Center — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh, UPMC Cancer Pavilion — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology, Sarah Cannon Research Institute — Nashville, Tennessee, United States
• BUMC Mary Crowley Cancer Research Centers — Dallas, Texas, United States
• MD Anderson — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
• Scientia Clinical Research — Randwick, New South Wales, Australia
• Greenslopes Private Hospital — Brisbane, Queensland, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Linear Clinical Research — Perth, Western Australia, Australia
• CHA Centre Hospitalier de l'Ardenne — Libramont, Chevigny, Belgium
• Saint Augustinus Hospital — Antwerp, Belgium
• Institut Jules Bordet — Brussels, Belgium
• CHU Brugmann — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium

Full record on ClinicalTrials.gov

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