REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer — REACTION

Gastroesophageal Cancer Clinical Trial

Official title:
REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer

Status Active, not recruiting

Clinical Trial Summary

This is a Phase 1B study assessing the safety of immune checkpoint inhibition after SBRT in patients with recurrent or metastatic gastroesophageal cancer (limited metastatic disease).

Clinical Trial Description

This is a Phase 1B study assessing the safety of immune checkpoint inhibition after SBRT in patients with recurrent or metastatic gastroesophageal cancer (limited metastatic disease). Arm A explores the safety and efficacy of nivolumab alone, and Arm B explores the safety and efficacy of nivolumab plus Relatlimib. Patients with recurrent or metastatic esophagogastric cancer are eligible for this study which will enroll patients with limited disease burden and who are Programmed death-1(PD-1) therapy naïve. This will allow for us to assess if systemic ablative radiation (SBRT to multiple metastatic sites plus PD-1/ anti-LAG3) is able to enhance the effectiveness of nivolumab +/- anti-LAG3 or to overcome treatment resistance mechanisms. Patients will be treated with targeted high dose radiation (SBRT) to metastatic lesions as outlined below. One of the lesions which is considered the easiest to biopsy and not causing symptoms will not be radiated so as to obtain tissue for correlative analysis. This lesion will then be re-biopsied approx. 4 weeks after the completion of radiation to the other metastatic sites. If a lesion is causing pain or other symptoms this site will not be chosen as the biopsiable site. The chosen metastatic lesion can then be irradiated at a later date if we do not see disease response in that region. Approximately 21 patients will be enrolled on study with 6 enrolled on Arm A, and 15 enrolled on Arm B. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03610711
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	March 6, 2019
Completion date	April 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04544046` - Supportive Oncology Care At Home RCT	N/A
Not yet recruiting	`NCT04555304` - Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy	Phase 2
Terminated	`NCT02669914` - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors	Phase 2
Completed	`NCT04099641` - An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients	Phase 2
Not yet recruiting	`NCT05431738` - Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)	N/A
Recruiting	`NCT04385641` - Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer	N/A
Completed	`NCT03165994` - APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers	Phase 2
Active, not recruiting	`NCT03279237` - A Pilot Study of FOLFIRINOX in Combination With Neoadjuvant Radiation for Gastric and GE Junction Cancers	Phase 1
Completed	`NCT03321630` - A Phase II a Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies	Phase 2
Completed	`NCT02853474` - Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy	Phase 3
Recruiting	`NCT05620134` - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer	Phase 1/Phase 2
Active, not recruiting	`NCT03983954` - Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors	Phase 1
Active, not recruiting	`NCT06138223` - The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)	N/A
Active, not recruiting	`NCT03647969` - Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer	Phase 2
Recruiting	`NCT05122091` - Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma	Phase 2
Completed	`NCT03720678` - A Study to Evaluate Immunotherapy Combinations in Participants With Gastrointestinal Malignancies	Phase 1
Completed	`NCT02317991` - Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer	Phase 2
Completed	`NCT02013154` - A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab	Phase 1
Terminated	`NCT05395052` - FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors	Phase 1
Recruiting	`NCT06356311` - A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)	Phase 3