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

Johns Hopkins Medicine

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Cancer Non-resectable

Pancreatic Cancer Metastatic

Treatments

Drug: INCMGA00012 (PD-1 antibody)

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT04116073

J19106

P50CA062924 (U.S. NIH Grant/Contract)

IRB00224849 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.