Clinical trial NCT03277352: INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Official title: A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Malignancies
Metastatic Cancer
Keywords: cervical cancer
endometrial cancer
gastric cancer (including stomach and gastroesophageal junction (GEJ))
esophageal cancer
hepatocellular carcinoma (HCC)
melanoma (mucosal or cutaneous)
Merkel cell carcinoma
mesothelioma
microsatellite instability-high (MSI-H)
solid tumors
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: 2017-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.


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 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).

Primary outcomes:
measure: Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
timeFrame: Screening through 60 days after end of treatment, up to approximately 18 months
measure: Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
measure: Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary outcomes:
measure: Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
measure: Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
measure: Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
measure: Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
timeFrame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
measure: Phase 1 & Phase 2: Overall Survival
timeFrame: At 1 year and 2 years.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Incyte Corporation
name: John N. Janik, MD
role: STUDY_DIRECTOR
References: