Clinical trial NCT03126110: Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Official title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Malignancies
Metastatic Cancer
Keywords: cervical cancer
endometrial cancer
gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ])
hepatocellular carcinoma (HCC)
melanoma
Merkel cell carcinoma
mesothelioma
microsatellite instability-high (MSI-H) colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)
ovarian cancer
squamous cell carcinoma of the head and neck (SCCHN)
small cell lung cancer (SCLC)
renal cell carcinoma (RCC)
triple-negative breast cancer (TNBC)
urothelial carcinoma
glucocorticoid-induced tumor necrosis factor receptor (GITR)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 145
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 INCAGN01876 when given in combination with immune therapies in subjects 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 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).

Primary outcomes:
measure: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately 27.4 months
measure: Phase 2: Objective Response Rate (ORR) Per RECIST v1.1
timeFrame: up to approximately 44.7 months
Secondary outcomes:
measure: Phase 1: ORR Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: ORR Per Modified RECIST (mRECIST) v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: ORR Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Duration of Response (DOR) Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: DOR Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: DOR Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: DOR Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Disease Control Rate (DCR) Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: DCR Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: DCR Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: DCR Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Duration of Disease Control Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: Duration of Disease Control Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Duration of Disease Control Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: Duration of Disease Control Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Progression-free Survival (PFS) Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: PFS Per RECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: PFS Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 2: PFS Per mRECIST v1.1
timeFrame: up to approximately 44.7 months
measure: Phase 1: Overall Survival
timeFrame: up to approximately 44.7 months
measure: Phase 2: Overall Survival
timeFrame: up to approximately 44.7 months
measure: Phase 2: : Number of Participants With Any TEAE
timeFrame: up to approximately 27.4 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University - Siteman Cancer Center
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma, Sarah Cannon Research Institute
state: Oklahoma
city: Portland
country: United States
facility: Providance Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, UPMC Cancer Pavilion
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology, Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: BUMC Mary Crowley Cancer Research Centers
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
state: New South Wales
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Brisbane
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Libramont
country: Belgium
facility: CHA Centre Hospitalier de l'Ardenne
state: Chevigny
city: Antwerpen
country: Belgium
facility: Saint Augustinus Hospital
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: CHU Brugmann
city: Charleroi
country: Belgium
facility: Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: Institut Catala D'Oncologia-Badalona
city: Barcelona
country: Spain
facility: Hospital Vall de Hebron
city: Córdoba
country: Spain
facility: Hospital Reina Sophia
city: Madrid
country: Spain
facility: University Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Doce de Octubre
city: Madrid
country: Spain
facility: Hospital HM Sanchinarro
city: Pamplona
country: Spain
facility: Clinica Universidad De Navarra (CUN)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Incyte Corporation
name: John E. Janik, MD
role: STUDY_DIRECTOR
References: