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

  • STATUS
    Recruiting
  • End date
    Aug 20, 2028
  • participants needed
    25
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 4 October 2022
cancer
measurable disease
antiretroviral therapy

Summary

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

Details
Condition Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic
Treatment INCMGA00012 (PD-1 antibody)
Clinical Study IdentifierNCT04116073
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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