Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

INTRODUCTION

Org Study ID: INCAGN 1876-201
Secondary ID: N/A
NTC ID: NCT03126110
Sponsor: Incyte Biosciences International Sàrl

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.

Overall Status
Recruiting
Start Date
April 13, 2017
Phase
Phase 1/Phase 2
Study Type
Interventional

Primary Outcome 1 - Measure: 1. Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)

Primary Outcome 1 - Timeframe: Screening through 60 days after end of treatment, up to 18 months

Primary Outcome 2 - Measure: Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Primary Outcome 2 - Timeframe: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months

Advanced Malignancies
Metastatic Cancer

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).

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Name: John E. Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Name: John E. Janik, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com

Facility	Status	Contact
Facility: Hospital HM Sanchinarro Madrid, 28050 Spain	Status: Recruiting	Contact: Study Coordinator +34 917567825
Facility: University Hospital Virgen de la Victoria Málaga, 29010 Spain	Status: Recruiting	Contact: Study Coordinator +34 671 59 45 67
Facility: Clinica Universidad De Navarra (CUN) Pamplona, 31008 Spain	Status: Recruiting	Contact: Study Coordinator +34 948255400
Facility: University Hospital Marqus de Valdecilla Santander, 39008 Spain	Status: Recruiting	Contact: Study Coordinator +34 942 20 25 25
Facility: The Angeles Clinic and Research Institute Los Angeles, California 90025 United States	Status: Recruiting	Contact: Study Coordinator 310-231-2121
Facility: University of Florida Gainesville, Florida 32610 United States	Status: Recruiting	Contact: Study Coordinator 352-273-7832
Facility: Karmanos Cancer Institute Detroit, Michigan 48201 United States	Status: Recruiting	Contact: Study Coordinator 313-576-9749
Facility: Washington University - Siteman Cancer Center Saint Louis, Missouri 37201 United States	Status: Recruiting	Contact: Study Coordinator 314-747-1864
Facility: Hackensack University Medical Center Hackensack, New Jersey 07601 United States	Status: Recruiting	Contact: Study Coordinator 551-996-5256
Facility: Memorial Sloan Kettering Cancer New York, New York 10065 United States	Status: Recruiting	Contact: Study Coordinator 646-888-4441
Facility: The University of North Carolina at Chapel Hill Chapel Hill, North Carolina 27599 United States	Status: Recruiting	Contact: Study Coordinator 919-966-0405
Facility: University of Oklahoma, Sarah Cannon Research Institute Oklahoma City, Oklahoma 73104 United States	Status: Recruiting	Contact: Study Coordinator 405-271-8001
Facility: Providance Portland Medical Center Portland, Oregon 97213 United States	Status: Recruiting	Contact: N/A
Facility: Robert W. Franz Cancer Research Center Portland, Oregon 97213 United States	Status: Recruiting	Contact: Study Coordinator 503-215-7192
Facility: Fox Chase Cancer Center Philadelphia, Pennsylvania 19111 United States	Status: Recruiting	Contact: Study Coordinator 215-214-1676
Facility: University of Pittsburgh, UPMC Cancer Pavilion Pittsburgh, Pennsylvania 15232 United States	Status: Recruiting	Contact: Study Coordinator 412-648-6586
Facility: Tennessee Oncology, Sarah Cannon Research Institute Nashville, Tennessee 37201 United States	Status: Recruiting	Contact: Study Coordinator 615-329-7413
Facility: BUMC Mary Crowley Cancer Research Centers Dallas, Texas 75230 United States	Status: Recruiting	Contact: Study Coordinator 214-658-1944
Facility: MD Anderson Houston, Texas 77030 United States	Status: Recruiting	Contact: Study Coordinator 713-794-1751
Facility: Seattle Cancer Care Alliance Seattle, Washington 98109 United States	Status: Recruiting	Contact: Study Coordinator 206-288-7051
Facility: Blacktown Cancer and Haematology Centre Blacktown, New South Wales 2148 Australia	Status: Recruiting	Contact: Study Coordinator +61 2 8670 5071
Facility: Scientia Clinical Research Randwick, New South Wales 2148 Australia	Status: Recruiting	Contact: Study Coordinator +61 2 9382 8823
Facility: Greenslopes Private Hospital Brisbane, Queensland 4120 Australia	Status: Recruiting	Contact: Study Coordinator +61 0 7 3394 7082
Facility: Linear Clinical Research Perth, Western Australia 6009 Australia	Status: Recruiting	Contact: Study Coordinator +61 8 6382 5113
Facility: CHA Centre Hospitalier de l'Ardenne Libramont, Chevigny 6800 Belgium	Status: Recruiting	Contact: Study Coordinator +32 61622683
Facility: Saint Augustinus Hospital Antwerpen, 2610 Belgium	Status: Recruiting	Contact: Study Coordinator +32 34433759
Facility: Institut Jules Bordet Brussels, 1000 Belgium	Status: Recruiting	Contact: Study Coordinator +32 25413197
Facility: Cliniques Universitaires Saint-Luc Brussels, 1200 Belgium	Status: Recruiting	Contact: Study Coordinator +32 27644217
Facility: CHU Brugmann Bruxelles, 1020 Belgium	Status: Recruiting	Contact: Study Coordinator +32 24773312
Facility: Grand Hopital de Charleroi Charleroi, 6000 Belgium	Status: Recruiting	Contact: Study Coordinator +32 71104760
Facility: Mi Kryviy Rih Center of Dnipropetrovsk Regional Council Charleroi, 6000 Belgium	Status: Recruiting	Contact: N/A
Facility: Ghent University Hospital Ghent, 37201 Belgium	Status: Recruiting	Contact: Study Coordinator +32 93320031
Facility: AZ Groeninge Kortrijk, 8500 Belgium	Status: Recruiting	Contact: Study Coordinator +32-56633941
Facility: IRRCS Instituto Clinico Humanitas Rozzano, 20089 Italy	Status: Recruiting	Contact: Study Coordinator +32 0282244080
Facility: Hospital Clinic I Provincial Barcelona, 08036 Spain	Status: Recruiting	Contact: N/A
Facility: Hospital Clinico y Provincial de Barcelona Barcelona, 08036 Spain	Status: Recruiting	Contact: Study Coordinator +34 93 227 54 00
Facility: Hospital Vall de Hebron Barcelona, Spain	Status: Recruiting	Contact: Study Coordinator +34 93 489 43 32
Facility: Hospital Reina Sophia Córdoba, 14004 Spain	Status: Recruiting	Contact: Study Coordinator +34 620640721
Facility: University Hospital Ramon y Cajal Madrid, 28034 Spain	Status: Recruiting	Contact: Study Coordinator +34 91 336 82 63
Facility: Hospital Universitario Doce de Octubre Madrid, 28041 Spain	Status: Recruiting	Contact: Study Coordinator +34 913908339

Brief Title: Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

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

INTRODUCTION

BRIEF SUMMARY

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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