INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2018 |
Start Date: | November 21, 2017 |
End Date: | February 2020 |
A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of
INCAGN01876 when given in combination with immune therapies.
INCAGN01876 when given in combination with immune therapies.
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).
We found this trial at
2
sites
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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