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A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

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: NCT03597295
Recruitment Status : Active, not recruiting
First Posted : July 24, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date June 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
Overall response rate (ORR) [ Time Frame: Up to approximately 6 months ]
Defined as the percentage of participants having a 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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
Overall response rate (ORR) [ Time Frame: Up to approximately 3 years ]
Defined as the percentage of participants having a 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: September 30, 2020)
  • Duration of response [ 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 [ Time Frame: Up to approximately 3 years ]
    Defined as the number of participants maintaining either an ORR or stable disease.
  • Progression-free survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the first dose of study treatment until disease progression by ICR or death due to any cause.
  • Overall survival [ 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 3 years ]
    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 plasma 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 plasma concentration over the dose interval.
  • AUC0-t of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • Duration of response [ 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 [ Time Frame: Up to approximately 3 years ]
    Defined as the number of participants maintaining either an ORR or stable disease lasting at least 6 months.
  • Progression-free survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the first dose of study treatment until disease progression by ICR or death due to any cause.
  • Overall survival [ 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 plasma 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 plasma concentration over the dose interval.
  • AUC0-t of INCMGA00012 [ Time Frame: Up to approximately 6 months ]
    Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
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 Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
Official Title  ICMJE A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)
Brief Summary The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Anal Canal
Intervention  ICMJE Drug: Retifanlimab
INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
Other Names:
  • MGA012
  • INCMGA00012
Study Arms  ICMJE Experimental: INCMGA00012
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: March 31, 2021)
94
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
81
Estimated Study Completion Date  ICMJE February 17, 2022
Actual Primary Completion Date June 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to comprehend and willingness to sign a written informed consent form.
  • Confirmed diagnosis of locally advanced or metastatic SCAC.
  • Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
  • Must have measurable disease by RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

Exclusion Criteria:

  • Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
  • Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
  • Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
  • Active autoimmune disease requiring systemic immunosuppression.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known active hepatitis infection.
  • Active infections requiring systemic therapy.
  • Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
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 Belgium,   Denmark,   France,   Germany,   Italy,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597295
Other Study ID Numbers  ICMJE INCMGA 0012-202
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
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Incyte Medical Monitor Incyte Corporation
PRS Account Incyte Corporation
Verification Date March 2021

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