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

• Status: Terminated
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Biosciences International Sàrl
• Treatments: Pembrolizumab

Criteria

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).