Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma



Status:Not yet recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 39
Updated:4/5/2019
Start Date:June 2019
End Date:June 2022
Contact:Tiffany Smith
Email:affiliate.research@moffitt.org
Phone:813-745-6250

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A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent, Resectable Osteosarcoma

The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab
in combination with azacitidine in participants with recurrent, resectable osteosarcoma

Treatment will be administered in 28 day cycles with the first cycle in the neoadjuvant
setting. This will be followed by surgery to render the participant in surgical remission.
Subsequently the participant will continue to receive treatment for up to 12 additional
cycles or until recurrence, whichever occurs first. For participants with known bilateral
lung recurrence, the nodule[s] in one lung should be resected, prior to the first cycle of
chemotherapy.

Inclusion Criteria:

- Participants must have had a histologic diagnosis of osteosarcoma at original
diagnosis

- Disease Status: Patients with an isolated pulmonary recurrence of osteosarcoma can be
enrolled on this study.

- Any history of metastatic disease at a site other than lung would make the
patient ineligible for this study.

- The patient's treating team must consider the patient's disease to be resectable
and the patient must be willing to undergo resection of all disease, including
any lung lesion meeting criteria for likely metastatic disease, defined as: 3 or
more lesions ≥ 3 mm in diameter OR a single lesion ≥ 5 mm.

- Patients with bilateral disease are eligible provided their disease is considered
resectable. Resectable pulmonary nodules are defined as nodules that can be
removed without performing a pneumonectomy (e.g., nodules immediately adjacent to
the main stem bronchus or main pulmonary vessels).

- Must have a performance status corresponding to Eastern Cooperative Oncology Group
(ECOG) scores of 0, 1 or 2, using the Karnofsky scale for patients > 16 years of age
and the Lansky scale for patients ≤ 16 years of age

- Prior Therapy: Participants must have fully recovered from the acute toxic effects of
all prior chemotherapy, immunotherapy, or radiotherapy prior to the start of protocol
therapy.

- Participants must have normal organ and marrow function within 7 days of starting
protocol therapy

- All participants and/or their parents or legal guardians must have the ability to
understand and the willingness to sign a written informed consent/assent document

- Additional criteria may apply

Exclusion Criteria:

- Pregnancy or Breast Feeding

- Males and females of reproductive potential may not participate unless they have
agreed to the use of, at minimum, two methods of contraception, with one method being
highly effective and the other method being either highly effective or less effective
as outlined in study protocol documentation

- Concomitant Medications: Patients receiving the following are not eligible:

- Corticosteroids or other immunosuppressive medications

- Patients who are currently receiving other investigational agents or other anti-cancer
therapy

- Intercurrent Illnesses: Patients with uncontrolled intercurrent illness including, but
not limited to:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

- Autoimmune disorders: Patients with a history of any Grade autoimmune disorder are not
eligible.

- Asymptomatic laboratory abnormalities (e.g., ANA, rheumatoid factor, altered thyroid
function studies) will not render a patient ineligible in the absence of a diagnosis
of an autoimmune disorder.

- Patients with ≥ Grade 2 hypothyroidism due to history of autoimmunity are not
eligible. Note: Hypothyroidism due to previous irradiation or thyroidectomy will not
impact eligibility

- Allergies: Patients with a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to Nivolumab (e.g., another humanized
antibody) or Azacitidine are not eligible

- Safety and Monitoring: Patients who are considered unable to comply with the safety
monitoring requirements of the study are not eligible

- Patients with known HIV or hepatitis B or C are excluded

- Patients who have received prior solid organ transplantation are not eligible

- Patients who have received prior anti-PD-1 directed therapy (mAb or small molecule)
are not eligible
We found this trial at
18
sites
1611 Northwest 12th Avenue
Miami, Florida 33124
Principal Investigator: Matteo Trucco, M.D.
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Bhuvana Setty, M.D.
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Michael Isakoff, M.D.
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Scott Borinstein, M.D.
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Emi Caywood, M.D.
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Wilmington, DE
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Brian Ladle, M.D., Ph.D.
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Baltimore, MD
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Bronx, New York 10467
Principal Investigator: David Loeb, M.D., Ph.D.
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Bronx, NY
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Chapel Hill, North Carolina 27599
Principal Investigator: Patrick Thompson, M.D.
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Chapel Hill, NC
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Charlotte, North Carolina 28203
Principal Investigator: Javier Oesterheld, M.D.
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Charlotte, NC
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1600 Southwest Archer Road
Gainesville, Florida 32608
Principal Investigator: William Slayton, M.D.
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Gainesville, FL
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807 Childrens Way
Jacksonville, Florida 32207
Principal Investigator: Eric Sandler, M.D.
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Jacksonville, FL
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Lexington, Kentucky
Principal Investigator: Lars Wagner, M.D.
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Lexington, KY
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Los Angeles, California 90027
Principal Investigator: Leo Mascarenhas, M.D.
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Los Angeles, CA
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Orlando, Florida 32806
Principal Investigator: Ramamoorthy Nagasubramanian, M.D.
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Orlando, FL
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Pooja Hingorani, M.D.
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Saint Petersburg, Florida 33701
Principal Investigator: Jonathan Metts, M.D.
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Saint Petersburg, FL
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Salt Lake City, Utah 84113
Principal Investigator: Douglas Fair, M.D.
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Salt Lake City, UT
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12902 USF Magnolia Drive
Tampa, Florida 33612
Principal Investigator: Damon Reed, M.D.
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Tampa, FL
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