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

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: NCT03599713
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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: Retifanlimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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 : February 25, 2019
Actual Primary Completion Date : January 21, 2022
Estimated Study Completion Date : July 23, 2023


Arm Intervention/treatment
Experimental: Retifanlimab: Chemotherapy: Naïve Advanced Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • MGA012
  • INCMGA00012

Experimental: Retifanlimab: Chemotherapy: Naïve Metastatic Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • MGA012
  • INCMGA00012

Experimental: Retifanlimab: Chemotherapy: Refractory Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • MGA012
  • INCMGA00012




Primary Outcome Measures :
  1. Objective Response Rate (ORR) in chemotherapy-naive participants with advanced/metastatic MCC, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent Central Radiographic Review (ICR) [ Time Frame: up to approximately 8 months ]
    ORR: percentage of participants with complete response (CR) or (PR) at any post-Baseline visit before the first Progressive Disease (PD) or new anticancer therapy. Evaluation of target lesions (TLs): CR: Disappearance of all TLs. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: ≥30% decrease in the sum of diameters of TLs, taking as reference the Baseline sum diameters. PD: ≥20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions (NTLs): CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PD: Unequivocal progression of existing NTLs. (Note: the appearance of one or more new lesions is also considered PD).


Secondary Outcome Measures :
  1. Duration of Response (DOR) in chemotherapy-naive participants with advanced/metastatic MCC, according to RECIST v1.1, as Determined by ICR [ Time Frame: up to approximately 2 years ]
    DOR: the time from an initial objective response (CR or PR) until PD, or death due to any cause. Evaluation of TLs: CR: Disappearance of all TLs. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: ≥30% decrease in the sum of diameters of TLs, taking as reference the Baseline sum diameters. PD: ≥20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions (NTLs): CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PD: Unequivocal progression of existing NTLs. (Note: the appearance of one or more new lesions is also considered PD). A Kaplan-Meier estimate (estimated median) of the distribution function is reported.

  2. Disease Control Rate (DCR) in chemotherapy-naive participants with advanced/metastatic MCC [ Time Frame: up to approximately 2 years ]
    DCR was defined as the percentage of participants with either an objective response (CR or PR) or Stable Disease (SD) lasting at least 6 months. Evaluation of target lesions: CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Evaluation of non-target lesions: (CR) Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis).

  3. Progression-free Survival (PFS) in chemotherapy-naive participants with advanced/metastatic MCC [ Time Frame: up to approximately 2 years ]
    PFS was defined the time from the start of therapy until disease progression, or death due to any cause, as determined by the ICR. Evaluation of target lesions: PD: ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered PD). Evaluation of non-target lesions: PD: Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered PD).

  4. Overall Survival in chemotherapy-naive participants with advanced/metastatic MCC [ Time Frame: up to approximately 2 years ]
    Overall survival was defined as the time from the start of therapy until death due to any cause.

  5. Number of participants with any treatment-emergent adverse event (TEAE) [ Time Frame: up to approximately 2 years ]
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as either an AE reported for the first time or a worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. An AE with onset after starting a new anticancer therapy was not summarized as a TEAE.

  6. Cmax of retifanlimab [ Time Frame: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days). ]
    Cmax was defined as the maximum observed plasma concentration.

  7. tmax of retifanlimab [ Time Frame: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days). ]
    tmax was defined as the time to the maximum concentration.

  8. Cmin of retifanlimab [ Time Frame: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days). ]
    Cmin was defined as the minimum observed plasma concentration over the dose interval.

  9. AUCt of retifanlimab [ Time Frame: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days). ]
    AUCt was defined as the area under the plasma concentration-time curve from time zero to time t.



Information from the National Library of Medicine

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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 amenable to surgery or radiation
  • 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 systemic therapy for MCC, including chemotherapy and prior PD-1 or 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.

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): NCT03599713


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03599713    
Other Study ID Numbers: INCMGA 0012-201
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
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
Infections
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue