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A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Clinical Trial Details

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin, works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent).

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. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Key Eligibility: 
  • Age 18 or older
  • Measurable stage III, IVA, IVB or recurrent endometrial cancer 
  • No prior chemotherapy for treatment of endometrial cancer or prior adjuvant chemotherapy completed at least 12 months prior to registration
  • Prior radiation therapy is permitted 
  • ECOG 0-2 
  • No prior treatment with anti-PD-1, anti PD-L1, or anti CTLA-4 therapeutic antibody or other similar agents 
  • No history of severe hypersensitivity reaction to monoclonal antibody or pembrolizumab and/or its excipients
  • No current participation and receiving cancer-directed study therapy, unless more than 4 weeks prior
  • No diagnosis of immunodeficiency or are receiving systemic steroid or immunosuppressive therapy
  • Diagnosis of brain metastases are eligible if no evidence of progression 
  • No history of pneumonitis 
  • Uncontrolled intercurrent illness
  • No clinically significant liver disease 
  • Not pregnant or lactating 

Study contact by location

Brooklyn

Contact(s)

Lina Flores, RN
(718) 965-9859
lif9061@nyp.org

Primary Investigator(s)

Margaux Kanis, MD  (BRK)

Protocol ID(s)

Weill Cornell Medicine IRB #:

20-08022601

ClinicalTrials.gov:

NCT03914612

Sponsor:

NRG-GY018

Status

Open to Enrollment

Age Group

Adult

Sponsor