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

• Status: Recruiting
• Trial end date: 2028-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Incyte Corporation
• Treatments: Antibodies; Immunoglobulins

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.