Nivolumab-Ipiliumab

“Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers"

STUDY AT A GLANCE

 

SUMMARY

The main purpose of this study is to determine the safety and effectiveness of nivolumab and ipilimumab for patients with relapsed or refractory INI1- negative tumors.  Patients with multiple types of solid tumors and brain tumors will be included as part of this study.  Patients will only be eligible for this study if their tumor has shown a mutation/deletion of a gene that is known to suppress tumor growth called INI1.

TRIAL INFORMATION

What to expect:

  • Patients will be screened for eligibility by the site study staff

  • Patients will receive intravenous (IV) treatment with both nivolumab and ipilimumab for 4 cycles and will then receive only nivolumab beginning with Cycle 5

  • Safety and side effects of study treatment will be monitored at every clinic visit and for 30 days after the last dose of study treatment

 

APPROACH

 

Treatment:  

a.) Patients will receive a combination of a predetermined dose of nivolumab and ipilimumab every 21 days for a total of 4 cycles.

b. )Starting with Cycle 5, patients will receive a predetermined dose of nivolumab only at day 1 and day 15 every 28 days.

 

ELIGIBILITY

Inclusion Criteria

  • Patient’s must be 6 monts-30 years of age at the time of study enrollment

  • Histologically confirmed tumor at original diagnosis or relapse

  • Must have tumor assessment showing the loss of INI1

  • Relapsed/refractory disease with no standard treatment options

  • Measurable disease on RANO criteria

  • All prior treatment side effects are fully resolved, and appropriate treatment washout periods are complete at the time of enrollment

  • Patients must have adequate organ function that will be confirmed through a routine blood draw

  • Patients must have adequate pulmonary function

  • Females of childbearing age must have a negative pregnancy test.

  • Females and males of childbearing age must agree to use appropriate contraception

 

Exclusion Criteria

  • Receiving other investigational medication

  • Use of systemic steroid medications without the approval of the study PI (Topical, inhaled, or ophthalmic steroids are acceptable)

  • Known history of HIV, hepatitis B or C

  • Uncontrolled other illness

  • History of pneumonitis requiring steroids

  • Active autoimmune disease that has required treatment in the past 12 months or sever autoimmune disease the requires steroids or immunosuppressive medications

  • Prior organ transplant

  • Pregnant or breastfeeding

  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PDl2 or anti-CTLA4 agent

  • Live vaccine within 30 days of study treatment

ADDITIONAL INFORMATION

NCT04416568

Full Details on ClinicalTrials.Gov

This protocol is available at Dana Farber Cancer Institute in Boston, Massachusetts.

CONTACT INFORMATION

Lead Investigator:  Susan Chi, MD

Dana Farber Cancer Institute [Boston, MA]

View Investigator Page

Trial Contact:

Suzanne Forrest, MD

Email: suzanne_forrest@dfci.harvard.edu

Hope4ATRT Foundation

is a research entity of

Out of Zion, Inc.

Mailing Address: 

P.O. Box 6130   New York, NY  10150