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
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
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