Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

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)

Keywords

Squamous Cell Carcinoma of Anal Canal Squamous carcinoma of the anal canal anti-PD-1 antibody IgG4 monoclonal antibody INCMGA00012 Carcinoma Carcinoma, Squamous Cell Antibodies

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
Sign up for this study
ID
NCT03597295
Phase
Phase 2
Study Type
Interventional
Last Updated