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INCAGN01876 in Combination With Immune Therapies in Subjects With 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.

Tracking Information
First Received DateAugust 14, 2017
Last Changed DateNovember 2, 2018
Start DateNovember 21, 2017
Anticipated Primary Completion DateDecember 2019
Primary Outcome Measures

Phase 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [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: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 2: Complete response rate (CRR) based on RECIST v1.1 [Time Frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months]

Secondary Outcome Measures

Phase 1: ORR based on RECIST v1.1 and mRECIST [Time Frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Disease control rate based on RECIST v1.1 and mRECIST [Time Frame: Assessed every 9 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 [Time Frame: Assessed every 9 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 [Time Frame: Assessed every 9 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 [Time Frame: Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months]

Phase 1 & Phase 2: Overall survival [Time Frame: At 1 year and 2 years.]

Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [Safety and Tolerability] [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 Cancer
Intervention
  • Drug: INCAGN01876
  • Drug: Epacadostat
  • Drug: Pembrolizumab
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment10
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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).

Administrative Information
NCTIDNCT03277352
Responsible PartySponsor
SponsorIncyte Biosciences International Sàrl
Verification DateNovember 2018
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