Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer

Summary

This phase II trial studies the effect of chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery in treating patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body (non-metastatic). Pembrolizumab is an immunotherapy drug that works by harnessing the immune system to attack cancer. Lenvatinib is an anti-cancer drug that works by stopping or slowing down the growth of cancer cells. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery may kill more tumor cells.

Conditions

• Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Esophageal Adenocarcinoma
• Esophageal Squamous Cell Carcinoma
• Pathologic Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions

DRUG

Carboplatin

Given IV

PROCEDURE

Endoscopic Biopsy

Undergo endoscopic biopsy

RADIATION

External Beam Radiation Therapy

Undergo EBRT

DRUG

Lenvatinib Mesylate

Given PO

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Resection

Undergo surgical resection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Vincent Chung, MD · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-25

Primary Completion

2027-04-25

Completion

2027-04-25

FDA Drug

Yes

Countries

• United States

Study Locations