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

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.

Tracking Information
First Received DateApril 19, 2017
Last Changed DateMay 17, 2017
Start DateApril 13, 2017
Anticipated Primary Completion DateJanuary 2020
Primary Outcome Measures

Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [Time Frame: Screening through 60 days after end of treatment, up to 18 months]

Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months]

Secondary Outcome Measures

Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1) [Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST v1.1 [Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.1 [Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1 [Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Overall survival [Time Frame: 1 year, 2 years, and end of study, up to 24 months]

Phase 1 & Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events [Time Frame: Screening through 60 days after end of treatment, up to 18 months]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Advanced Malignancies
  • Metastatic Malignancies
Intervention
  • Drug: INCAGN01876
  • Drug: Nivolumab
  • Drug: Ipilimumab
Study Arms / Comparison Groups3 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment450
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Incyte Corporation Call Center (US)
Email: medinfo@incyte.com
Phone: 1.855.463.3463
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 endometrial cancer, gastric cancer (including stomach, esophageal, and GEJ), and SCCHN.

- 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 an immune-therapy.

- 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).

Administrative Information
NCTIDNCT03126110
Responsible Party,
SponsorIncyte Corporation
Verification DateMay 2017
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