Retifanlimab in Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer

What is the Purpose of this Study?

This study focuses on individuals who have an advanced or metastatic adenosquamous pancreas or ampullary cancer (ASQ). The purpose of the study is to evaluate the effectiveness and safety of an investigational drug called retifanlimab in ASQ, a rare type of pancreas or ampullary cancer. Retifanlimab (also known as INCMGA00012 or MGA012) is a monoclonal antibody made in a laboratory. Antibodies exist in the body and are a type of protein normally made by immune cells that helps protect the body against foreign matter, such as bacteria and viruses. Retifanlimab works by attaching to and blocking a protein called PD-1. PD-1 is present on different types of cells in the immune system and can shut down the immune cells so that they do not effectively fight disease. Researchers also aim to learn how retifanlimab affects the immune system and cancer. The study will evaluate whether various biomarkers found in the blood and tumor can predict how the tumor responds to retifanlimab and whether certain white blood cells are able to enter the patient’s tumor after the drug is received. The study may also include gene sequencing of participants’ tumor samples and T-cell receptors.


Eligibility

  • Age ≥18 years.
  • Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.
  • Has unresectable or metastatic measurable disease.
  • Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.
Show more

Where can I participate?

Cedars-Sinai Cancer at SOCC : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

EIIT2022-J19106: A Phase II trial of retifanlimab in patients with previously treated unresectable or metastatic adenosquamous pancreatic or ampullary cancer.

Study Details
Disease Type/Condition

Pancreas

Principal Investigator

Osipov, Arsen

Co-Investigators

Andrew Hendifar, Jun Gong, Kevin Waters, Matthew Ebia

Age Group

Adult

Phase

II

IRB Number

STUDY00001941

ClinicalTrials.gov ID

NCT04116073

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Pancreas

Principal Investigator

Osipov, Arsen

Age Group

Adult

Phase

II

IRB Number

EIIT2022-J19106

ClinicalTrials.gov ID

NCT04116073

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org