Clinical trial NCT03241173: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
Official title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Malignancies
Keywords: advanced or metastatic cervical cancer
endometrial cancer
esophageal cancer
hepatocellular carcinoma (HCC)
melanoma
Merkel cell carcinoma
mesothelioma
microsatellite instability-high colorectal cancer
non-small cell lung cancer (NSCLC)
ovarian cancer
squamous cell carcinoma of the head and neck
small cell lung cancer (SLCL)
renal cell carcinoma (RCC)
triple-negative breast cancer
TNBC
urothelial carcinoma
OX40 ligand (OX40)
SCCHN
MSI-H CRC
gastric cancer (including stomach and gastroesophageal junction [GEJ])
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 17.4 months
measure: Phase 1: Number of Participants With a Grade 3 or Higher TEAE
timeFrame: up to 17.4 months
measure: Phase 2: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Phase 1: ORR
timeFrame: up to 15.6 months
measure: Phase 1: Duration of Response (DOR)
timeFrame: up to 11.0 months
measure: Phase 2: DOR
timeFrame: up to 24 months
measure: Phase 1: Disease Control Rate (DCR)
timeFrame: up to 15.6 months
measure: Phase 2: DCR
timeFrame: up to 24 months
measure: Phase 1: Duration of Disease Control
timeFrame: up to 15.4 months
measure: Phase 2: Duration of Disease Control
timeFrame: up to 24 months
measure: Phase 1: Progression-free Survival (PFS)
timeFrame: up to 15.6 months
measure: Phase 2: PFS
timeFrame: up to 24 months
measure: Phase 2: Number of Participants With TEAEs
timeFrame: up to 24 months
measure: Phase 2: Number of Participants With a Grade 3 or Higher TEAE
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama Birmingham (UAB)
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Hospitals DBA HonorHealth
state: Arizona
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Miami
country: United States
facility: Mount Sinai Medical Center of Florida, Inc.
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center At Hackensack UMC
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers, The State University
state: New Jersey
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, LLC (SCRI)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: John E. Janik, MD
role: STUDY_DIRECTOR
References: