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A Study of Nivolumab in Selected Uterine Cancer Patients

A Study of Nivolumab in Selected Uterine Cancer Patients

Clinicaltrials.gov identifier:
NCT03241745

Treatment:
Endometrial

Study Contact Information:

Principal Investigator:
Claire Friedman, MD
by phone: 646-888-4247 or by email  


A Study of Nivolumab in Selected Uterine Cancer Patients

About the Study

The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab on patients with metastatic or recurrent uterine cancer. 

Nivolumab is a type of immunotherapy known as an immune checkpoint inhibitor. Immune checkpoint inhibitors are drugs that prevent cancer cells from switching off immune cells. This allows the immune system to find, unmask and destroy cancer cells.

Type of Study

This is a non-randomized, open-label, phase 2 study.  All patients in this study belong to the same study group, and will receive the same therapeutic treatment.  

What the Study Entails

Patients in this study will receive an IV dose of Nivolumab once every 4 weeks. Treatment will continue until time of disease progression or until treatment discontinuation for other reason, for up to 24 weeks.

Study Locations

Connecticut

Hartford Healthcare Cancer Institute @ Hartford Hospital      
Hartford, Connecticut
Contact: Amy Brown, MD    860-972-4341     

Florida

Miami Cancer Institute Baptist Health South Florida    
Miami, Florida
Contact: John Paul Diaz, MD    786-596-2000     

New Jersey

Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Contact: Claire Friedman, MD    646-888-4247   

Memorial Sloan Kettering Monmouth     
Middletown, New Jersey
Contact: Claire Friedman, MD    646-888-4247     

Memorial Sloan Kettering Bergen
Montvale, New Jersey
Contact: Claire Friedman, MD    646-888-4247     

New York

Memorial Sloan Kettering Commack      
Commack, New York
Contact: Claire Friedman, MD    646-888-4247     

Memorial Sloan Kettering Westchester  
Harrison, New York
Contact: Claire Friedman, MD    646-888-4247     

Memorial Sloan Kettering Cancer Center         
New York, New York
Contact: Claire Friedman, MD    646-888-4247     
Contact: Martee Hensley, MD    646 888-4222     
Principal Investigator: Claire Friedman, MD        

Memorial Sloan Kettering Nassau
Uniondale, New York
Contact: Clarie Friedman, MD    646-888-4247      

Pennsylvania

Lehigh Valley Health Network     
Allentown, Pennsylvania
Contact: Surech Nair, MD    610-402-7880     

This Study is Open To:

Women, age 18 years or older, are eligible if they have:

  • Metastatic or recurrent uterine cancer.  Cancers in the ovary/fallopian tube or peritoneum may also be eligible.
  • Tumor is MSI-high, or MMR-deficient, or Hypermutated (> 20 somatic mutations in the tumor per definition created by Memorial Sloan Kettering Cancer Center)
  • Received one or more prior lines of therapy designed to destroy cancer cells for advanced disease
  • Cancer recurrence that is no longer responsive to curative approaches such as surgical removal or using chemotherapy in combination with radiation.
  • No known Central Nervous System metastases
  • Available archived tumor tissue or patient is willing to undergo new biopsy
This Study is Not Open To:

Women with the following are not eligible:

  • Disease that is eligible for potentially curative treatment with standard chemotherapy, surgical removal, or combined chemotherapy with radiation.
  • Certain autoimmune diseases (study team will review patient history and determine eligibility)
  • Recent history of bowel obstruction, refractory ascites (unmanageable abdominal fluid build-up), or bowel perforation due to advanced disease
  • Had prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody targeting T cell co-stimulation or immune checkpoint pathways
  • Positive test for hepatitis B or hepatitis C
  • Known history of HIV or AIDS