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INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03277352
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( 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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Metastatic Cancer Drug: INCAGN01876 Drug: Epacadostat Drug: Pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
Drug: INCAGN01876
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.

Drug: Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
Other Name: INCB024360

Drug: Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.
Other Name: Keytruda®




Primary Outcome Measures :
  1. 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 ]
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

  2. 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 ]
    Defined as the percentage of subjects having complete response (CR) or partial response (PR).

  3. 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 ]
    Defined as the percentage of checkpoint inhibitor-naive melanoma subjects who have a CR.


Secondary Outcome Measures :
  1. 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 ]
    Defined as the percentage of subjects having CR or PR.

  2. 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. ]
    Defined as the percentage of subjects having CR, PR, or stable disease (SD).

  3. 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 ]
    Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.

  4. 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 ]
    Defined as time from first report of SD or better until disease progression or death from any cause.

  5. 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 ]
    Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.

  6. Phase 1 & Phase 2: Overall survival [ Time Frame: At 1 year and 2 years. ]
    Defined as the time from the start of combination therapy until death due to any cause.

  7. 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. ]
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277352


Locations
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United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
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Study Director: John N. Janik, MD Incyte Corporation

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Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT03277352     History of Changes
Other Study ID Numbers: INCAGN 1876-202
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
cervical cancer
endometrial cancer
gastric cancer (including stomach and gastroesophageal junction (GEJ))
esophageal cancer
hepatocellular carcinoma (HCC)
melanoma (mucosal or cutaneous)
Merkel cell carcinoma
mesothelioma
microsatellite instability-high (MSI-H)
solid tumors
non-small cell lung cancer (NSCLC)
ovarian cancer
squamous cell carcinoma of the head and neck (SCCHN)
small cell lung cancer (SCLC)
renal cell carcinoma (RCC)
triple-negative breast cancer (TNBC)
urothelial carcinoma
glucocorticoid-induced tumor necrosis factor receptor (GITR)

Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents