Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Neoplasm Metastasis

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Trastuzumab

Oxaliplatin

Leucovorin

Fluorouracil

Avelumab

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Cycles 1-9; Induction; Cycle = 14 days

mFOLFOX6

* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and

Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and

Avelumab 800 mg IV Day 1

Cycles 10 and subsequent; Maintenance; Cycle = 14 days

Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1

5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion

5 fluorouracil

Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1

Ashwin Somasundaram, MD

The initial intent of the study was to be a multi-center single-arm open-label Simon's two-stage Phase II clinical trial of first-line mFOLFOX6 + trastuzumab + avelumab in metastatic HER2-amplified gastric and esophageal adenocarcinomas.

Accrual will halt after completion of Stage I (enrollment of 18 patients). This decision is not due to safety issues. Subjects currently on treatment will continue until criteria as defined in the protocol is met.

Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

A Single Arm, Multi-center Phase 2 Trial of mFOLFOX6 + Trastuzumab + Avelumab in First-line, Metastatic, HER2-amplified Gastric and Esophageal Adenocarcinomas

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

The bORR will be defined as the percentage of subjects whose best response by 24 weeks are either a CR or PR according to RECIST 1.1. For confirmed response, PR or CR need to be confirmed by repeat assessments that should be performed no less than 4 weeks. Otherwise, it will be considered as an unconfirmed response.

Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Progression Free Survival (PFS) will be defined as the time from the start date of treatment to the date of documented progression as determined by RECIST 1.1 or death from any cause.

Immune-RECIST Criteria(iRECIST): Complete Response(iCR), Disappearance of all measurable and non-measurable lesions; Partial Response (iPR), \>=30% decrease in tumor burden relative to baseline; Unconfirmed Progressive Disease (iUPD), \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Confirmed Progressive Disease (iCPD), confirmation of iUPD (by further growth) at the next assessment; Stable Disease (iSD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

iPFS will be defined as the time from the start date of treatment to the date of documented progression as determined by iRECIST criteria or death from any cause.

Overall Survival (OS) will be defined as the time from start of treatment to the date of death from any cause, or date of last contact (censored).

Disease Control Rate (DCR) will be defined as the total number of patients whose best responses are either a CR, PR, or SD divided by the number of response evaluable patients. Patients with best response of SD will need to maintain SD by 24 weeks to be considered to have received clinical benefit from the treatment regimen.

The frequency and severity of all grade 3-4 treatment related adverse events are reported by CTCAE v5.

EMD Serono

University of North Carolina, Chapel Hill

Ashwin Somasundaram

Sponsor-Investigator

Cycles 1-9; Induction; Cycle = 14 days

mFOLFOX6

* oxaliplatin 85 mg/m2 IV Day 1 and
* leucovorin 400 mg/m2 IV Day 1 and
* 5 fluorouracil 400 mg/m2 IV bolus and 2400 mg/m2 IV over 46 hours Day 1 and

Trastuzumab 6 mg/kg IV loading dose C1D1 then Trastuzumab 4 mg/kg IV Day 1 and

Avelumab 800 mg IV Day 1

Cycles 10 and subsequent; Maintenance; Cycle = 14 days

Trastuzumab 4 mg/kg Day 1 and Avelumab 800 mg Day 1

Oxaliplatin: Oxaliplatin 85 mg/m2

Leucovorin: Leucovorin 400 mg/m2

5 fluorouracil: 5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion

Trastuzumab: Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1

Avelumab: Avelumab 800 mg

Induction and Maintenance

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Primary Tumor Site

The IHC (immunohistochemistry) test gives a score of 0 to 3+ that measures the amount of HER2 (human epidermal growth factor receptor 2) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called HER2 negative. If the score is 2+, it's called borderline. A score of 3+ is called HER2 positive.

HER2 IHC

Combined positive score (CPS) is defined as the number of positive tumor cells, lymphocytes and macrophages, divided by the total number of viable tumor cells multiplied by 100. A lower CPS score means better outcome or less positive cells.

Spots Global Cancer Trial Database for Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas

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