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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

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ClinicalTrials.gov Identifier: NCT03599713
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief Summary:
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Condition or disease Intervention/treatment Phase
Metastatic Merkel Cell Carcinoma Drug: INCMGA00012 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: INCMGA00012 Drug: INCMGA00012
INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.
Other Name: MGA012


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate in chemotherapy-naive participants [ Time Frame: Up to approximately 3 years ]
    Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).


Secondary Outcome Measures :
  1. Overall response rate in the full study population (chemotherapy-naive and chemotherapy-refractory participants) [ Time Frame: Up to approximately 3 years ]
    Defined as the percentage of participants with an objective response (CR or PR) according to RECIST v1.1 as determined by ICR.

  2. Duration of response in the chemotherapy-naive and full study populations [ Time Frame: Up to approximately 3 years ]
    Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause.

  3. Disease control rate in the chemotherapy-naive and full study populations [ Time Frame: Up to approximately 3 years ]
    Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months.

  4. Progression-free survival in the chemotherapy-naive and full study populations [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the start of therapy until disease progression as determined by the ICR or death due to any cause.

  5. Overall survival in the chemotherapy-naive and full study populations [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the start of therapy until death due to any cause.

  6. Number of treatment-emergent adverse events [ Time Frame: Up to approximately 27 months ]
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.

  7. Cmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Maximum observed serum concentration.

  8. tmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Time to maximum concentration.

  9. Cmin of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Minimum observed serum concentration over the dose interval.

  10. AUCt of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Area under the serum concentration-time curve.


Eligibility Criteria
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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:

  • Signed informed consent.
  • Diagnosis of MCC with distant metastatic disease or recurrent advanced locoregional disease not amendable to surgery or radiation and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Measurable disease according to RECIST v1.1.
  • Availability of tumor tissue (fresh or archival) for central pathology review.
  • Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

  • Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
  • Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
  • Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
  • Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • History of second malignancy within 3 years (with exceptions).
  • Laboratory values outside the protocol-defined range at screening.
  • Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
  • Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
  • Receipt of a live vaccine within 28 days of planned start of study therapy.
  • Current use of protocol-defined prohibited medication.
  • Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
  • Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
  • Participant who is pregnant or breastfeeding.
Contacts and Locations
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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): NCT03599713


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03599713     History of Changes
Other Study ID Numbers: INCMGA 0012-201
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Metastatic merkel cell carcinoma
anti-PD-1 antibody
immunoglobulin G4 (IgG4) monoclonal antibody
INCMGA00012
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
 Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Antibodies
Immunologic Factors
Physiological Effects of Drugs