Clinical Trials /

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

NCT04116073

Description:

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

Related Conditions:
  • Pancreatic Adenosquamous Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer
  • Official Title: A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: J19106
  • SECONDARY ID: IRB00224849
  • NCT ID: NCT04116073

Conditions

  • Pancreatic Cancer Non-resectable
  • Pancreatic Cancer Metastatic

Interventions

DrugSynonymsArms
INCMGA00012 (PD-1 antibody)MGA012INCMGA00012 (PD-1 antibody)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012 (PD-1 antibody)ExperimentalAll participants will receive the interventional study drug; INCMGA00012.
  • INCMGA00012 (PD-1 antibody)

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Control Rate (DCR) at 4 months using RECIST 1.1
Time Frame:4 months
Safety Issue:
Description:DCR at 4 months following the start of treatment with INCMGA00012, which is defined as the proportion of subjects with PR or CR or stable disease according to RECIST 1.1 following 4 months from the start of therapy.

Secondary Outcome Measures

Measure:Number of subjects with partial response (PR) or complete response (CR)
Time Frame:4 years
Safety Issue:
Description:Number of subjects with partial response (PR) or complete response (CR) according to RECIST 1.1 will be used to assess Objective response rate (ORR).
Measure:Number of months from the first dose of INCMGA00012 to disease progression (PD) or relapse from complete response
Time Frame:4 years
Safety Issue:
Description:Number of months from the first dose of INCMGA00012 to disease progression (PD) or relapse from complete response (CR) as assessed using RECIST 1.1 or death. This will be used in assessing Progression-free survival (PFS).
Measure:Number of participants experiencing study drug-related toxicities
Time Frame:4 years
Safety Issue:
Description:Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Antibody
  • Anti-PD-1
  • Human monoclonal immunoglobulin antibody
  • Immunotherapy
  • INCMGA00012 (anti-PD-1 antibody)
  • Anti-PD-1 antibody (MGA012)
  • Metastatic adenosquamous pancreatic cancer
  • Unresectable adenosquamous pancreatic cancer
  • Adenosquamous pancreatic cancer
  • Programmed cell death protein 1 (PD-1)
  • Programmed death-ligand 1 (PD-L1)

Last Updated