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.

Inclusion Criteria:

* 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.
* Presence of at least one lesion with measurable disease.
* Accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* If HIV-positive, then all of the following criteria must also be met: cluster of differentiation (CD) 4+ count ≥ 350/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
* Men must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

* Known history or evidence of brain metastases.
* Has had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study drug.
* Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
* Expected to require any other form of systemic or localized antineoplastic therapy while on study.
* Has had major surgery within 28 days of dosing of investigational agent, excluding minor procedures.
* Has received a live vaccine within 28 days prior to the first dose of study drug.
* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, anti-OX40 and LAG-3 antibodies)
* Have used any systemic steroids within 14 days of study treatment.
* Hypersensitivity reaction to any monoclonal antibody.
* Evidence of clinical or radiographic ascites.
* Have clinically significant and/or malignant pleural effusion.
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of autoimmune disease requiring systemic immunosuppression within the last 2 years.
* Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded.
* All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to a grade 1 or baseline before administration of study drug.
* Infection with Hepatitis A, B or C.
* Patient has a pulse oximetry of \<92% on room air.
* Patient is on supplemental home oxygen.
* Has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing.
* Patient has clinically significant heart disease.
* Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse.
* Unwilling or unable to follow the study schedule for any reason.
* Patient has history of non-infectious pneumonitis.
* Serum albumin level less than 2.8 g/dL.

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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

IRB Number

STUDY00001941

ClinicalTrials.gov ID

NCT04116073

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Abrahm Levi

Abrahm.Levi@cshs.org