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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

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date May 9, 2022
Actual Study Start Date  ICMJE February 25, 2019
Actual Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2022)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2022)
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Cmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Maximum observed serum concentration.
  • tmax of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Time to maximum concentration.
  • Cmin of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Minimum observed serum concentration over the dose interval.
  • AUCt of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Area under the serum concentration-time curve.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Official Title  ICMJE A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Merkel Cell Carcinoma
Intervention  ICMJE Drug: Retifanlimab
INCMGA00012 administered at 500 milligrams (mg) by intravenous infusion once every 4 weeks
Other Names:
  • MGA012
  • INCMGA00012
Study Arms  ICMJE
  • Experimental: Retifanlimab: Chemotherapy: Naïve Advanced
    Intervention: Drug: Retifanlimab
  • Experimental: Retifanlimab: Chemotherapy: Naïve Metastatic
    Intervention: Drug: Retifanlimab
  • Experimental: Retifanlimab: Chemotherapy: Refractory
    Intervention: Drug: Retifanlimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 28, 2021)
107
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
90
Estimated Study Completion Date  ICMJE July 23, 2023
Actual Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03599713
Other Study ID Numbers  ICMJE INCMGA 0012-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Incyte Medical Monitor Incyte Corporation
PRS Account Incyte Corporation
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP