INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer

Study Overview
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Brief Summary
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Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.

Official Title
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A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer

Conditions
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Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic

Intervention / Treatment
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* Drug: INCMGA00012 (PD-1 antibody)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INCMGA00012 (PD-1 antibody)<br>All participants will receive the interventional study drug; INCMGA00012. | Drug: INCMGA00012 (PD-1 antibody)<br>* Treatment of INCMGA00012 will be administered every 4 weeks (28 days) while patient is on study. Intravenous administration of INCMGA00012 (500 mg) will occur on Day 1 of each 28 day cycle. Drug: 500 mg is to be administered as a 30 minute IV infusion (-5/+15 min)<br>* Other names: MGA012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) at 4 months using RECIST 1.1 | DCR at 4 months following the start of treatment with INCMGA00012, which is defined as the proportion of subjects with PR or CR or stable disease according to RECIST 1.1 following 4 months from the start of therapy. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with partial response (PR) or complete response (CR) | Number of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1 will be used to assess Objective response rate (ORR). | 4 years | 
| Number of months from the first dose of INCMGA00012 to disease progression (PD) or relapse from complete response | Number of months from the first dose of INCMGA00012 to disease progression (PD) or relapse from complete response (CR) as assessed using RECIST 1.1 or death. This will be used in assessing Progression-free survival (PFS). | 4 years | 
| Number of participants experiencing study drug-related toxicities | Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibody, Anti-PD-1, Human monoclonal immunoglobulin antibody, Immunotherapy, INCMGA00012 (anti-PD-1 antibody), Anti-PD-1 antibody (MGA012), Metastatic adenosquamous pancreatic cancer, Unresectable adenosquamous pancreatic cancer, Adenosquamous pancreatic cancer, Programmed cell death protein 1 (PD-1), Programmed death-ligand 1 (PD-L1)