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

• Status: Completed
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Incyte Biosciences International Sàrl; Incyte Corporation
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

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 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.

Exclusion Criteria:

• 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.