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A Study of WT1 Vaccine and Nivolumab For Recurrent Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02737787
First received: April 5, 2016
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to test the safety of a combination of an investigational WT1 vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and nivolumab are being used in combination.

Condition Intervention Phase
Ovarian Cancer
Fallopian Tube
Primary Peritoneal Cancer
Recurrent Ovarian Cancer
Biological: WT1 Vaccine
Drug: Nivolumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Study of Concomitant WT1 Analog Peptide Vaccine With Montanide and GM-CSF in Combination With Nivolumab in Patients With Recurrent Ovarian Cancer Who Are in Second or Greater Remission

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Dose limiting toxicity (DLT) [ Time Frame: 30 days ]
    The first 3 patients will be observed for 30 days before enrolling the next 7 patients. Accrual will continue as patients become available after the first 3 patients are observed for 30 days. If >2/10 DLTs are observed then the study combination will not be considered safe.


Estimated Enrollment: 10
Actual Study Start Date: April 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WT1 Vaccine and Nivolumab
Patients will initially receive 6 vaccinations over 12 weeks and 7 infusions of nivolumab over 14 weeks. Toxicity assessments will be performed with each dose of vaccine, and 3 weeks after the completion of therapy at week 15. Patients who do not have disease progression at the week 15 evaluation are permitted to receive 4 additional vaccines administered approximately every 8 weeks. This maintenance vaccine course would begin at week 19.
Biological: WT1 Vaccine Drug: Nivolumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologic diagnosis of ovarian, fallopian tube or primary peritoneal cancer confirmed by pathology review at MSK.
  • Patients will have relapsed at least once and returned to complete clinical remission after additional chemotherapy. Interval surgery is permitted.
  • Complete clinical remission is defined as CA-125 within normal limits, examination and CT or MRI without objective evidence of disease (non specific abnormalities are permitted on radiologic imaging).
  • Patients may sign screening consent during recurrence or at time of remission if they can start vaccine therapy within 4 months of completing chemotherapy.
  • Testing of patient's archived (paraffin embedded, unstained slides) or freshly biopsied tumor nodules must be positive for WT1 protein expression. WT1 expression: Immunohistochemical analysis will be performed using the technique described by Dupont et al [58]. WT1 expression will be graded according to an adaptation of the German Immunoreactive Score (IRS). Only tumors with moderate to strong IRS scores (4-12) will be considered WT1 positive.
  • Age ≥ 18 years
  • Karnofsky performance status ≥ 70%
  • Hematologic parameters: Absolute neutrophil count ≥ 1000/mcL, Platelets > 50 K/mcL.
  • Biochemical parameters: Total bilirubin ≤ 1.5 mg/dl, AST and ALT ≤ 2.5 x upper limits of normal, Creatinine ≤ 1.5 mg/dl.
  • Patient of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing and effective form of birth control

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments
  • Patients with a serious unstable medical illness or another active cancer.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Patients with known active hepatitis B virus or hepatitis C virus acute or chronic infection.
  • Patients with active known or suspected autoimmune disease (treated hypothyroidism is permitted to enroll)
  • Patients with active interstitial pneumonitis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02737787

Contacts
Contact: Roisin O'Cearbhaill, MD 646-888-4227
Contact: Paul Sabbatini, MD 212-639-4016

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
Contact: Paul Sabbatini, MD    212-639-4016      
Principal Investigator: Roisin O'Cearbhaill, MD         
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
Memorial Sloan Kettering Westchester Recruiting
West Harrison, New York, United States, 10604
Contact: Roisin O'Cearbhaill, MD    646-888-4227      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Roisin O'Cearbhaill, MB BCh BAO Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02737787     History of Changes
Other Study ID Numbers: 15-247
Study First Received: April 5, 2016
Last Updated: January 25, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Second or Greater Remission
WT1 Analog Peptide Vaccine
Montanide
GM-CSF
Nivolumab
15-247

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Vaccines
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on March 24, 2017