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

  • STATUS
    Recruiting
  • End date
    Oct 5, 2025
  • participants needed
    45
  • sponsor
    Dana-Farber Cancer Institute
Updated on 5 June 2022
renal function
cancer
absolute neutrophil count
monoclonal antibodies
measurable disease
small molecule
growth factor
karnofsky performance status
kidney function tests
human chorionic gonadotropin
neutrophil count
nivolumab
ipilimumab
cancer chemotherapy
myelosuppressive chemotherapy
sarcoma
epithelioid sarcoma

Summary

This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.

Description

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug or drug combination to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The names of the study drugs involved in this study are:

  • Nivolumab (OPDIVO)
  • Ipilimumab (YERYOY)

This trial is studying whether nivolumab and ipilimumab work to treat INI1-negative cancers.

The U.S. Food and Drug Administration (FDA) has not approved combination nivolumab and ipilimumab for the specific diseases in this study but it has been approved for other diseases. Nivolumab and ipilimumab have been tested in children to find out a safe dose of this combination.

Details
Condition Malignant Rhabdoid Tumor, Rhabdoid Tumor of the Kidney, Epithelioid Sarcoma, Chordoma (Poorly Differentiated or De-differentiated), Atypical Teratoid/Rhabdoid Tumor, Other INI1 Negative Malignant Tumors (With PI Approval)
Treatment Ipilimumab, Nivolumab
Clinical Study IdentifierNCT04416568
SponsorDana-Farber Cancer Institute
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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 malignant tumors (with PI approval)
Stratum 2
Atypical teratoid rhabdoid tumor (ATRT)
Other INI1-negative 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
Relapsed or refractory disease and no standard treatment options as determined by
Measurable disease as defined by RECIST v1.1 (Stratum 1) or RANO criteria (Stratum 2)
locally or regionally available standards of care and treating physician's
Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy. Participants must meet the following minimum washout periods prior to first day of study treatment
discretion
Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy
Radiotherapy
Karnofsky performance status ≥ 50% for participants ≥16 years of age and Lansky performance status ≥ 50% for participants <16 years of age
At least 14 days after local palliative XRT (small port)
At least 90 days must have elapsed after prior TBI, craniospinal XRT or if >50% radiation of pelvis
At least 42 days must have elapsed if other substantial BM radiation
At least 42 days must have passed since last radionuclide therapy (e.g. samarium or radium)
Monoclonal antibody: At least 21 days after the last dose
Myeloid growth factors: At least 14 days following the last dose of long-acting growth factor (e.g. Neulasta) or 7 days following short-acting growth factor
Stem Cell or Autologous T Cell Infusion: At least 42 days must have elapsed after stem cell or autologous T cell infusion
Small molecule biologic therapy: At least 7 days following the last dose of a
Participants must have adequate organ function as defined below
nonmonoclonal biologic agent
Bone Marrow Function
Hepatic Function
Absolute neutrophil count ≥500/uL
Platelets ≥50,000/uL and transfusion independent
Renal function
Total bilirubin ≤ 1.5 x upper limit of normal for age
A serum creatinine within protocol limits based on age/sex. OR
ALT (SGPT) ≤ 3 x upper limit of normal
Creatinine clearance ≥ 70 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Negative B-HCG pregnancy test in females of childbearing potential (must be drawn within 24 hours prior to initial administration of nivolumab)
Adequate Pulmonary Function Defined as: no evidence of dyspnea at rest, no
Women of childbearing potential (WOCBP) receiving nivolumab agree to adhere to contraception for a period of 5 months after the last dose of nivolumab. Men receiving nivolumab and who are sexually active with WOCBP will agree to adhere to contraception for a period of 7 months after the last dose of nivolumab
exercise intolerance due to pulmonary insufficient and a pulse oximetry > 92%
Ability to understand and/or the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent using an institutionally approved informed consent procedure
while breathing room air
Adequate pancreatic function defined as serum lipase ≤ ULN at baseline

Exclusion Criteria

Participants who are receiving any other investigational agents
Participants must not be receiving concomitant systemic steroid medications The use of physiologic doses of corticosteroids (up to 5 mg/m2/day prednisone equivalent) may be approved after consultation with the PI (treatment with topical, inhaled or ophthalmic corticosteroid is acceptable)
Participants with a known history of HIV, hepatitis B, and/or hepatitis C
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or any other concurrent disease which in the judgment of the Investigator would make the subject inappropriate for enrollment on this study
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has active autoimmune disease that has required systemic treatment in the past 12 months, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are exceptions. Intermittent use of bronchodilators or local steroid injections are not excluded. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diagnoses not listed must be approved by the Principal Investigator
Patients who have received prior solid organ transplantation are not eligible
Pregnancy or Breast-Feeding. Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX-40, CD137)
Participants who have received live / attenuated vaccine within 30 days of first dose of study treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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