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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

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

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.


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

PRIMARY OUTCOMES

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

CONDITION

  • Advanced Malignancies
  • Metastatic Cancer

ELIGIBILITY


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

OFFICIAL INFORMATION

Name: John E. Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: John E. Janik, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com

LOCATION

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