INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreat… (NCT04116073) | Clinical Trial Compass
CompletedPhase 2
INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer
United States25 participantsStarted 2020-04-09
Plain-language summary
Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Disease Control Rate (DCR) at 4 Months Using RECIST 1.1
Timeframe: 4 months
Trial details
NCT IDNCT04116073
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins