Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers (NCT04416568) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers
United States45 participantsStarted 2020-08-14
Plain-language summary
This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.
Who can participate
Age range6 Months – 40 Years
SexALL
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Inclusion Criteria:
* All participants must have one of the following histologically confirmed tumors at original diagnosis or relapse:
* Stratum 1
* Malignant rhabdoid tumor (MRT)
* Rhabdoid tumor of the kidney (RTK)
* Epithelioid sarcoma
* Chordoma (poorly differentiated or de-differentiated)
* Other INI1-negative or SMARCA4-deficient malignant tumors (with PI approval)
* Stratum 2
* Atypical teratoid rhabdoid tumor (ATRT)
* Other INI1-negative or SMARCA4-deficient primary CNS malignant tumors (with PI approval)
* All participants must have tumor assessment at original diagnosis or relapse showing the following:
* Loss of INI1 confirmed by immunohistochemistry (IHC), OR
* Molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable
* Loss of SMARCA4 confirmed by IHC or molecular confirmation of tumor bi-allelic SMARCA4 loss or mutation when SMARCA4 is equivocal or unavailable
* Relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
* Measurable disease as defined by RECIST v1.1 (Stratum 1) or RANO criteria (Stratum 2)
* Karnofsky performance status ≥ 50% for participants ≥16 years of age and Lansky performance status ≥ 50% for participants \<16 years of age
* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy. Partic…