- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04116073
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
September 1, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joann Santmyer, RN
- Phone Number: 410-614-3644
- Email: GIClinicalTrials@jhmi.edu
Study Contact Backup
- Name: Colleen Apostal, RN
- Phone Number: 410-614-3644
- Email: GIClinicalTrials@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231
- Recruiting
- Sidney Kimmel Comprehensive Cancer Center
-
Contact:
- Trish Brothers, RN
- Phone Number: 410-614-3644
- Email: GIClinicaltrials@jhmi.edu
-
Contact:
- Joann Santmyer, RN
- Phone Number: 410-614-3644
- Email: GIClinicalTrials@jhmi.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INCMGA00012 (PD-1 antibody)
All participants will receive the interventional study drug; INCMGA00012.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Control Rate (DCR) at 4 months using RECIST 1.1
Time Frame: 4 months
|
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)
Time Frame: 4 years
|
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
Time Frame: 4 years
|
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
Time Frame: 4 years
|
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nilofer Azad, MD, Johns Hopkins Medical Institution
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2020
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
August 1, 2028
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 3, 2019
First Posted (Actual)
October 4, 2019
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
September 1, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
- Immunotherapy
- Anti-PD-1
- Antibody
- Programmed cell death protein 1 (PD-1)
- Human monoclonal immunoglobulin antibody
- INCMGA00012 (anti-PD-1 antibody)
- Anti-PD-1 antibody (MGA012)
- Metastatic adenosquamous pancreatic cancer
- Unresectable adenosquamous pancreatic cancer
- Adenosquamous pancreatic cancer
- Programmed death-ligand 1 (PD-L1)
Additional Relevant MeSH Terms
Other Study ID Numbers
- J19106
- IRB00224849 (Other Identifier: Johns Hopkins Medical Institution)
- P50CA062924 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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