Summary

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

Description

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).

Official Title

A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

Keywords

Metastatic Merkel Cell Carcinoma anti-PD-1 antibody immunoglobulin G4 (IgG4) monoclonal antibody INCMGA00012 Carcinoma, Merkel Cell Carcinoma Antibodies

Eligibility

You can join if…

Open to people ages 18 years and up

  • Signed informed consent.
  • Diagnosis of MCC with distant metastatic disease or recurrent advanced locoregional disease not amendable to surgery or radiation and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
  • 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.

You CAN'T join if...

  • Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (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.

Locations

  • University of California San Francisco Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT03599713
Phase
Phase 2
Study Type
Interventional
Last Updated