PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT02213289
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    Trastuzumab
  • ABT-806 — DRUG
    ABT-806
  • Bemarituzumab — DRUG
    Bemarituzumab
  • Ramucirumab — DRUG
    Ramucirumab
  • Nivolumab — DRUG
    Nivolumab
  • Standard cytotherapy — DRUG
    FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Study Details

The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.

Key Dates

Start date
Jan 20, 2015
Status verified
Mar 2021
Primary completion
Feb 1, 2020
Completion
Aug 20, 2020

Study Design

Enrollment
80 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)
    For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology included PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (HER2 amplified)
    HER2 amplified. These patients received standard cytotherapy plus Trastuzumab.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (EFGR amplified)
    EGFR amplified. These patients received ABT-806.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)
    FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)
    MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (EGFR expressing)
    EGFR expressing. These patients received standard cytotherapy plus ABT 806.
  • Experimental: ITT-PTS: Personalized Treatment Strategy (All negative)
    All negative. These patients received standard cytotherapy plus Ramucirumab.
  • Other: Non-ITT: Standard Therapy
    Patients without monoclonal antibodies available received standard cytotherapy.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 60 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-

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By research site
University of Chicago· Chicago, IL

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