Status:
COMPLETED
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
Lead Sponsor:
Incyte Biosciences International Sàrl
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03241173
Start Date
October 9 2017
End Date
September 17 2019
Last Update
September 27 2022
Active Locations (15)
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1
The University of Alabama Birmingham (UAB)
Birmingham, Alabama, United States, 90025
2
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States, 85258
3
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
4
Mount Sinai Medical Center of Florida, Inc.
Miami, Florida, United States, 33140