Status:
COMPLETED
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Incyte Corporation
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer Non-resectable
Pancreatic Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04116073
Start Date
April 9 2020
End Date
December 3 2024
Last Update
July 29 2025
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231