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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | April 13, 2017 | Phase 1/Phase 2 | Interventional |
Primary Outcome 1 - Measure: 1. Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
Primary Outcome 1 - Time Frame: Screening through 60 days after end of treatment, up to 18 months
Primary Outcome 2 - Measure: Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Primary Outcome 2 - Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months
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 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).
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: John E. Janik, MD
Role: Study Director
Affiliation: Incyte Corporation
Name: Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Email: medinfo@incyte.com
