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

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 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.

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).