A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04757363|
Recruitment Status : Active, not recruiting
First Posted : February 17, 2021
Last Update Posted : November 28, 2023
The purpose of this study is to find out whether combining nivolumab, FOLFOX, and regorafenib may be a safe and effective treatment for people who have HER2-negative metastatic esophagogastric cancer.
Nivolumab is an antibody, like the proteins made by the immune system to protect the body from harm. Nivolumab blocks the protein PD-1 (programmed cell death receptor-1) that usually acts as a "brake" on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target cancer cells and destroy them.
FOLFOX is a combination of three standard chemotherapy drugs (leucovorin, 5-fluorouracil, and oxaliplatin) commonly used to treat your type of cancer. The drugs work by damaging the DNA in cancer cells, which can cause the cells to stop growing and die.
Regorafenib is a type of drug called a tyrosine kinase inhibitor (TKI). This drug targets the tyrosine kinase protein found in or on the surface of cancer cells that the cells need to survive and grow. Blocking this protein may stop cancer cells from growing, or cause them to grow more slowly or to shrink.
The study researchers think that combining nivolumab, FOLFOX, and regorafenib may be a more effective treatment for HER2-negative metastatic esophagogastric cancer than the usual chemotherapy treatment(s) alone.
|Condition or disease||Intervention/treatment||Phase|
|Esophagogastric Cancer HER2-Negative||Drug: regorafenib Drug: nivolumab Drug: FOLFOX chemotherapy with oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single-arm, open-label, nonrandomized, single-institution, phase II study of nivolumab in combination with FOLFOX and regorafenib as first-line therapy in patients with metastatic esophagogastric adenocarcinoma.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Nivolumab in Combination With FOLFOX and Regorafenib in Patients With HER2-Negative Metastatic Esophagogastric Cancer|
|Actual Study Start Date :||February 11, 2021|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Experimental: Nivolumab Combined With FOLFOX and Regorafenib
Each treatment cycle consists of 28 days. Patients will initially receive induction therapy with regorafenib (80 mg on days 1-21 of the 28-day cycle) and nivolumab (240 mg on days 1 and 15 of the 28-day cycle). Starting on cycle 2, day 1, patients will also receive FOLFOX chemotherapy with oxaliplatin (85 mg/m2 IV), leucovorin (400 mg/m2 IV), 5-FU (400 mg/m2 IV bolus), and 5-FU (2400 mg/m2/day continuous IV infusion over 48 h). If the patient is not a good candidate for induction regorafenib and nivolumab (i.e. symptomatic from a large burden of disease), 5-FU and oxaliplatin can be added during cycle 1 at the treating physician's discretion. 39 Patients will continue with this regimen until disease progression, unacceptable toxicity, or development of serious intercurrent illness. Treatment will be performed on the scheduled day (±7-day treatment window).
regorafenib (80 mg on days 1-21 of the 28-day cycle)
nivolumab (240 mg on days 1 and 15 of the 28-day cycle).
Drug: FOLFOX chemotherapy with oxaliplatin
FOLFOX chemotherapy with oxaliplatin (85 mg/m2 IV), leucovorin (400 mg/m2 IV), 5-FU (400 mg/m2 IV bolus), and 5-FU (2400 mg/m2/day continuous IV infusion over 48 h).
- 6-month progression free Survival [ Time Frame: 6 months ]will be defined according to RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757363
|United States, New Jersey|
|Memorial Sloan Kettering Basking Ridge (All Protocol Activities)|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth (All Protocol Activities)|
|Middletown, New Jersey, United States, 07748|
|Memorial Sloan Kettering Bergen (All Protocol Activities)|
|Montvale, New Jersey, United States, 07645|
|United States, New York|
|Memorial Sloan Kettering Commack (All Protocol Activities)|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester (All Protocol Activities)|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center (All Protocol Activities)|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Nassau (All Protocol Activities)|
|Uniondale, New York, United States, 11553|
|Principal Investigator:||Yelena Janjigian, MD||Memorial Sloan Kettering Cancer Center|