Neoplasms

All Conditions

Symptoms and General Pathology

Adenocarcinoma

Disease Progression

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Nivolumab

Immunoglobulins

Ramucirumab

Bemarituzumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

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.

HER2 amplified. These patients received standard cytotherapy plus Trastuzumab.

EGFR amplified. These patients received ABT-806.

FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab.

EGFR expressing. These patients received standard cytotherapy plus ABT 806.

All negative. These patients received standard cytotherapy plus Ramucirumab.

Patients without monoclonal antibodies available received standard cytotherapy.

ABT-806

FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Standard cytotherapy

Daniel Catenacci, MD

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.

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

PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma

Time from enrollment to progression or death during first-line treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time from enrollment to death from any cause.

Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).

Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).

Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)

Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).

AbbVie

University of Chicago

Molecular arms/groups are combined for this analysis because the intent of the study was to compare the overall strategy of molecular-based treatment vs. not undertaking molecular-based therapy. Thus the number of patients with adverse events over the potential three lines of therapy is reported.

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806..

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

ITT-PTS: Personalized Treatment Strategy

For patients without monoclonal antibodies available.These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Non-ITT: Standard Therapy

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive patients received standard cytoptherapy plus Nivolumab

HER2 amplified patients received standard cytotherapy plus Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available, therapy was standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Overall Survival

Unit of analysis is the biopsy. Each patient had two biopsies, one of the primary tumor and one of a metastatic site.

Number of Biopsies Leading to an Adverse Event

Unit of analysis is the biopsy. Two biopsies were performed per patient, one of the primary tumor and one from a metastatic site.

Completion of Biopsy and Successful, Molecularly-based Treatment Assignment

This includes subset of patients administered second-line treatment

Adverse Event From Serial Biopsy for Second-line Treatment

Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patient including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806.

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

This includes subset of patients administered third-line treatment

Adverse Event From Serial Biopsy for Third-line Treatment

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plous ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

First-line Progression-free Survival

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806.

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

Objective Response to First Line Therapy

For patients with monoclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

Of note, while the protocol section describes these tailored therapies, the efficacy evaluation was based on pooling these treatments into a combined "personalized treatment strategy" group and comparing with historical controls. Therefore this "arm" includes all such patients with monoclonal antibodies available.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Of note, this arm includes patients without monoclonal antibodies available, for whom no personalized treatment strategy was available. The intent of the protocol was NOT to compare this arm with arm 1.

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

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