A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

  • STATUS
    Recruiting
  • End date
    Jan 25, 2023
  • participants needed
    60
  • sponsor
    Incyte Corporation
Updated on 11 November 2020
Investigator
Incyte Corporation Call Center
Primary Contact
Georgetown University - Lombardi Comprehensive Cancer Center (7.9 mi away) Contact
+74 other location

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).

Details
Treatment INCMGA00012, Retifanlimab
Clinical Study IdentifierNCT03599713
SponsorIncyte Corporation
Last Modified on11 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Metastatic Merkel Cell Carcinoma?
Signed informed consent
Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
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

Exclusion Criteria

Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet