Pembrolizumab and Chemoradiotherapy for the Treatment of Unresectable Gastroesophageal Cancer
NCT04522336 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-03-05
Summary
This phase I trial investigates how well pembrolizumab and chemoradiotherapy works in treating patients with gastroesophageal cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as fluorouracil, oxaliplatin and docetaxel 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 photons to kill tumor cells and shrink tumors. Giving pembrolizumab together with chemoradiotherapy may help to control gastroesophageal cancer.
Conditions
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Localized Gastroesophageal Junction Adenocarcinoma
- Locally Advanced Gastroesophageal Junction Adenocarcinoma
- Pathologic Stage III 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
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Unresectable Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
Given IV
- RADIATION
-
Radiation Therapy
Receive radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Jaffer A Ajani · M.D. Anderson Cancer 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
- 2020-09-16
- Primary Completion
- 2027-07-18
- Completion
- 2027-07-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study of Pembrolizumab in Locally Advanced Esophageal Adenocarcinoma
NCT02998268 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
NCT03604991 ·Status: SUSPENDED ·Phase: PHASE2/PHASE3
-
Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
NCT04435197 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers
NCT02642809 ·Status: COMPLETED ·Phase: PHASE1
-
Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC
NCT05541445 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Pembrolizumab Plus Neoadjuvant Chemotherapy for Locally Advanced EGJ Adenocarcinoma
NCT04813523 ·Status: UNKNOWN ·Phase: PHASE2
-
Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction
NCT00757172 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
NCT05319730 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
NCT01196390 ·Status: COMPLETED ·Phase: PHASE3
-
Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
NCT00551759 ·Status: TERMINATED ·Phase: PHASE2
-
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
NCT03792347 ·Status: COMPLETED ·Phase: PHASE1
-
S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer
NCT00109850 ·Status: TERMINATED ·Phase: PHASE2
-
Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
NCT06888531 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
NCT04210115 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
NCT06304350 ·Status: RECRUITING ·Phase: PHASE2
-
Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer
NCT02530437 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Cetuximab, Oxaliplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Esophageal Cancer
NCT00425425 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
NCT00069953 ·Status: COMPLETED ·Phase: PHASE2
-
Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
NCT00525915 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma
NCT04089904 ·Status: TERMINATED ·Phase: PHASE2
-
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
NCT04615013 ·Status: RECRUITING ·Phase: PHASE1
-
Bevacizumab and Combination Chemotherapy Before Surgery in Treating Patients With Locally Advanced Esophageal or Stomach Cancer
NCT01212822 ·Status: COMPLETED ·Phase: PHASE2
-
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
NCT03196232 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: a Single Center, Prospective, Open, One Arm Exploratory Clinical Study
NCT05028231 ·Status: UNKNOWN
-
Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)
NCT02564263 ·Status: COMPLETED ·Phase: PHASE3