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BRIEF 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

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


  • Org Study ID: INCAGN 1876-201
  • Secondary ID:
  • NCT ID: NCT03126110
  • NCT Alias:
  • Sponsor: Incyte Biosciences International Sàrl - Industry
  • Source: Incyte Corporation

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.

Overal Status Start Date Phase Study Type
Recruiting April 13, 2017 Phase 1/Phase 2 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 - Time Frame: 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 - Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months

Condition:

  • Advanced Malignancies
  • Metastatic Cancer

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).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: John E. Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: Incyte Corporation Call Center (US)

Phone: 1.855.463.3463

Email: medinfo@incyte.com

Locations

Facility Status Contact
The Angeles Clinic and Research Institute
Los Angeles, California 90025
United States
Recruiting Study Coordinator
310-231-2121
University of Florida
Gainesville, Florida 32610
United States
Recruiting Study Coordinator
352-273-7832
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Study Coordinator
313-576-9749
Washington University - Siteman Cancer Center
Saint Louis, Missouri 37201
United States
Recruiting Study Coordinator
314-747-1864
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Recruiting Study Coordinator
551-996-5256
Memorial Sloan Kettering Cancer
New York, New York 10065
United States
Recruiting Study Coordinator
646-888-4441
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Recruiting Study Coordinator
919-966-0405
University of Oklahoma, Sarah Cannon Research Institute
Oklahoma City, Oklahoma 73104
United States
Recruiting Study Coordinator
405-271-8001
Providance Portland Medical Center
Portland, Oregon 97213
United States
Recruiting
Robert W. Franz Cancer Research Center
Portland, Oregon 97213
United States
Recruiting Study Coordinator
503-215-7192
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting Study Coordinator
215-214-1676
University of Pittsburgh, UPMC Cancer Pavilion
Pittsburgh, Pennsylvania 15232
United States
Recruiting Study Coordinator
412-648-6586
Tennessee Oncology, Sarah Cannon Research Institute
Nashville, Tennessee 37201
United States
Recruiting Study Coordinator
615-329-7413
BUMC Mary Crowley Cancer Research Centers
Dallas, Texas 75230
United States
Recruiting Study Coordinator
214-658-1944
MD Anderson
Houston, Texas 77030
United States
Recruiting Study Coordinator
713-794-1751
Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Study Coordinator
206-288-7051
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
Australia
Recruiting Study Coordinator
+61 2 8670 5071
Scientia Clinical Research
Randwick, New South Wales 2148
Australia
Recruiting Study Coordinator
+61 2 9382 8823
Greenslopes Private Hospital
Brisbane, Queensland 4120
Australia
Recruiting Study Coordinator
+61 0 7 3394 7082
Austin Hospital
Heidelberg, Victoria
Australia
Not yet recruiting
Austin Hospital-Olivia Newton John Cancer Research Institute
Melbourne, Victoria 3084
Australia
Not yet recruiting Study Coordinator
+61 3 9496 3352
Linear Clinical Research
Perth, Western Australia 6009
Australia
Recruiting Study Coordinator
+61 8 6382 5113
CHA Centre Hospitalier de l'Ardenne
Libramont, Chevigny 6800
Belgium
Recruiting Study Coordinator
+32 61622683
Saint Augustinus Hospital
Antwerpen, 2610
Belgium
Recruiting Study Coordinator
+32 34433759
Institut Jules Bordet
Brussels, 1000
Belgium
Recruiting Study Coordinator
+32 25413197
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Recruiting Study Coordinator
+32 27644217
CHU Brugmann
Bruxelles, 1020
Belgium
Recruiting Study Coordinator
+32 24773312
Grand Hopital de Charleroi
Charleroi, 6000
Belgium
Recruiting Study Coordinator
+32 71104760
Mi Kryviy Rih Center of Dnipropetrovsk Regional Council
Charleroi, 6000
Belgium
Recruiting
Ghent University Hospital
Ghent, 37201
Belgium
Recruiting Study Coordinator
+32 93320031
AZ Groeninge
Kortrijk, 8500
Belgium
Recruiting Study Coordinator
+32-56633941
IRRCS Instituto Clinico Humanitas
Rozzano, 20089
Italy
Recruiting Study Coordinator
+32 0282244080
Hospital Clinic I Provincial
Barcelona, 08036
Spain
Recruiting
Hospital Clinico y Provincial de Barcelona
Barcelona, 08036
Spain
Recruiting Study Coordinator
+34 93 227 54 00
Institut Catala D'Oncologia-Badalona
Barcelona, 08916
Spain
Not yet recruiting Study Coordinator
+34 686 607 192
Hospital Vall de Hebron
Barcelona,
Spain
Recruiting Study Coordinator
+34 93 489 43 32
Hospital Reina Sophia
Córdoba, 14004
Spain
Recruiting Study Coordinator
+34 620640721
University Hospital Ramon y Cajal
Madrid, 28034
Spain
Recruiting Study Coordinator
+34 91 336 82 63
Hospital Universitario Doce de Octubre
Madrid, 28041
Spain
Recruiting Study Coordinator
+34 913908339
Hospital HM Sanchinarro
Madrid, 28050
Spain
Recruiting Study Coordinator
+34 917567825
University Hospital Virgen de la Victoria
Málaga, 29010
Spain
Recruiting Study Coordinator
+34 671 59 45 67
Clinica Universidad De Navarra (CUN)
Pamplona, 31008
Spain
Recruiting Study Coordinator
+34 948255400
University Hospital Marqus de Valdecilla
Santander, 39008
Spain
Recruiting Study Coordinator
+34 942 20 25 25