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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 : February 17, 2020
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 efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Anal Canal Drug: INCMGA00012 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: INCMGA00012 Drug: INCMGA00012
INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
Other Name: MGA012


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Disease control rate [ Time Frame: Up to approximately 3 years ]
    Defined as the number of participants maintaining either an ORR or stable disease.

  3. 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.

  4. Overall survival [ Time Frame: Up to approximately 3 years ]
    Defined as the time from the start of therapy until death due to any cause.

  5. 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.

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

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

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

  9. 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.


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:

  • 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.
Contacts and Locations
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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): NCT03597295


Locations
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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: NCT03597295    
Other Study ID Numbers: INCMGA 0012-202
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
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:
Squamous carcinoma of the anal canal
anti-PD-1 antibody
IgG4 monoclonal antibody
INCMGA00012
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Antibodies
Immunologic Factors
Physiological Effects of Drugs