Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable
or metastatic Adenosquamous Pancreatic Cancer (ASQ).
- Age ≥18 years.
- Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas.
- 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.
- 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
- 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
- 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.