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

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ClinicalTrials.gov Identifier: NCT03597295
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

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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 : December 2020
Estimated Study Completion Date : December 2021

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




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.



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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.

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


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

Locations
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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Study Coordinator    626-218-0867      
Principal Investigator: Dr. Fakih         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Study Coordinator    916-734-5946      
Principal Investigator: Dr. Cho         
United States, Florida
University of Florida - SHANDS CANCER CENTER Recruiting
Gainesville, Florida, United States, 32610
Contact: Study Coordinator    352-265-0680 ext 58003      
Principal Investigator: Dr. Parekh         
United States, Maryland
Maryland Oncology Hematology P.A. Recruiting
Rockville, Maryland, United States, 20850
Contact: Study Coordinator    240-826-2120      
Principal Investigator: Dr. Sotos         
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator 214-370-1000         
Principal Investigator: Dr. Paulson         
Renovatio Clinical Recruiting
Spring, Texas, United States, 77380
Principal Investigator: Dr Mary Crow         
Belgium
Zna Middelheim Recruiting
Antwerp, Belgium, 2020
Contact: Study Coordinator    +32 3 280 34 00      
Principal Investigator: Dr. Van Fraeyenhove         
Hopital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Study Coordinator    +32 25554455      
Principal Investigator: Dr. Demols         
France
CHU Hopital De La Timone Recruiting
Marseille, France, 13385
Contact: Study Coordinator    +33 491 384 284      
Principal Investigator: Dr. Dahan         
Hopital Universitaire Pitie-Salpetriere Recruiting
Paris, France, 75013
Contact: Study Coordinator    +33 142 160 464      
Principal Investigator: Dr. Spano         
CHU Toulouse Hopital Rangueil Recruiting
Toulouse, France, 31059
Contact: Study Coordinator    +33561322188 ext 42926      
Principal Investigator: Dr. Guimbaud         
Italy
Ospedale A. Perrino - Brindisi Recruiting
Brindisi, Italy, 72100
Contact: Study Coordinator    +39 0831537431      
Principal Investigator: Dr. Cinieri         
A.O.U. Policlinico V. Emanuele G. Rodolico Not yet recruiting
Catania, Italy, 95123
Contact: Study Coordinator    +39 095 3782426      
Principal Investigator: Dr. Soto Parra         
Niguarda Cancer Center Recruiting
Milano, Italy, 20162
Contact: Study Coordinator    +39 0264443695      
Principal Investigator: Dr. Siena         
Clinica La Maddalena Recruiting
Palermo, Italy, 90146
Contact: Study Coordinator    +39 0916806603      
Principal Investigator: Dr. Gebbia         
IRCCS Casa Sollievo Della Sofferenza Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: Study Coordinator    +39 0882 410716      
Principal Investigator: Dr. Latiano         
Spain
Hospital General Universitari Vall D Hebron Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34 934894375      
Principal Investigator: Dr. Capdevilla         
United Kingdom
Royal Marsden Hospital Recruiting
Chelsea, United Kingdom, SW3 6JJ
Contact: Study Coordinator    +44 207 811 8462      
Principal Investigator: Dr. Rao         
Castle Hill Hospital Recruiting
Cottingham, United Kingdom, HU16 5JQ
Contact: Study Coordinator    +44 148 246 1257      
Principal Investigator: Dr. Singh Dhadda         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BV
Contact: Study Coordinator    +44 161 446 8344      
Principal Investigator: +44 161 446 8344         
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Study Coordinator    +44 208 661 3808      
Principal Investigator: Dr. Rao         
Royal Cornwall Hospital, Sunrise Centre Recruiting
Truro, United Kingdom, TR1 3LQ
Contact: Study Coordinator    +44 187 225 8342      
Principal Investigator: Dr. Ellis         
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: NCT03597295     History of Changes
Other Study ID Numbers: INCMGA 0012-202
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 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:
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