Immunotherapy (Nivolumab and Ipilimumab) for the Treatment of Relapsed or Refractory INI-1 Negative Cancer

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Hematopoietic Malignancies Sarcoma	NCT ID:	NCT04416568
Trial Phases:	Phase II	Protocol IDs:	20-041 (primary) NCI-2020-04573
Eligibility:	6 Months - 40 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04416568

Summary

This phase II trial investigates how well nivolumab and ipilimumab work in treating patients with INI-1 negative cancer that has come back (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. To estimate the objective response rate (ORR) of nivolumab in combination with ipilimumab separately in each of the two strata of children and young adults with INI1-negative cancers, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for Stratum 1 and Response Assessment in Neuro-Oncology Criteria (RANO) for Stratum 2 per local assessment.

SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) and overall survival (OS) rates of patients with INI1-negative cancers treated with nivolumab and ipilimumab in each stratum and across both strata.
II. To estimate the disease control rate at 12 months in patients with INI1-negative cancers treated with nivolumab and ipilimumab in each stratum and across both strata.
III. To describe the toxicities of nivolumab given in combination with ipilimumab in children and young adults with INI1-negative cancers.

EXPLORATORY OBJECTIVE:
I. To describe biologic activity of study treatment as measured by correlative immunologic studies and to evaluate biomarkers of treatment response.

OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 90 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning in cycle 5, patients receive nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 14 cycles (12 months) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or confirmed response after 12 months of treatment may remain on study treatment beyond 12 months with approval from principal investigator. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study, as well as optional blood sample collection on study.

After completion of study treatment, patients are followed up eat 30 days and every 6 months for up to 2 years.

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