This phase II trial studies how well cemiplimab works in treating patients with nuclear protein of testis (NUT) carcinoma for which no treatment is currently available (incurable) and that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE: I. Assess the preliminary effect of cemiplimab treatment on survival in patients with recurrent, or advanced NUT carcinoma (NC) at 6 months from start of treatment. SECONDARY OBJECTIVES: I. Assess NC patients treated with cemiplimab for overall radiographic response. II. Assess the duration of documented radiographic response in cemiplimab treated NC patients. III. Assess the clinical benefit by radiographic response rate in cemiplimab treated NC patients. IV. Assess the overall survival (OS) of cemiplimab-treated NC patients. V. Assess the safety, toxicity, and tolerability of cemiplimab treatment in patients with NC. VI. Assess quality of life (QOL) for cemiplimab treated NC patients via the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version \[v\]3.0 survey. EXPLORATORY OBJECTIVES: I. To comprehensively molecularly characterize NC samples obtained from patients. II. To gain deeper insights into the spatial organization of NUT midline carcinoma (NMC). III. Characterize the landscape of immune cells in treatment-naïve and previously treated NC patients. OUTLINE: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 32 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or digital photography as well as blood sample collection and optional tumor biopsies throughout the study. After completion of study treatment, patients are followed every 3 months for 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Undergo optional biopsy
Undergo collection of blood samples
Given IV
Undergo CT
Undergo digital photography
Undergo MRI
Ancillary studies
Northwestern University
Chicago, Illinois, United States
RECRUITINGOverall survival (OS)
The statistical analysis plan for the percentage of patients alive at 6 months will primarily involve a survival analysis using Kaplan-Meier methods. The point estimate of the treatment effect, as well as the associated 2-sided 95% confidence interval (CI), will be estimated using a Cox-proportional-hazards model.
Time frame: At the beginning of cycle 1, day 1 (each cycle is 21 days) to the time of death from any cause, assessed at 6 months.
Overall response rate (ORR)
Will calculate the proportion of treated patients who experience an objective response (confirmed complete response \[CR\] or confirmed partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1). The date of first response for either CR or PR will be used for the calculation of ORR. The proportion of evaluable patients experiencing an objective response will be estimated with a 95% exact binomial CI. The confidence interval will be adjusted for the sequential nature of the two-stage procedure.
Time frame: Up to 24 months after completion of study treatment
Duration of response (DOR)
Response is defined as confirmed CR or confirmed PR per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using descriptive statistics, and the CR rate of nuclear protein of testis carcinoma in patients will be determined.
Time frame: From the day of first documented response to trial therapy (CR or PR, whichever is first recorded) and subsequent disease progression, assessed up to 24 months after completion of study treatment
Clinical response rate
Will calculate the proportion of treated, evaluable patients who experience clinical benefit from trial therapy. Clinical benefit is defined as confirmed CR; confirmed PR; or stable disease for ≥ 6 months per RECIST 1.1. Will be estimated with a proportion and CI.
Time frame: From the initiation of trial therapy until the patient experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first, assessed up to 24 months after completion of study treatment
OS
Will be analyzed using the Kaplan-Meier method. The median OS estimate will be reported along with the CI.
Time frame: From start of treatment (Cycle 1, Day 1) to the time of death from any cause, assessed at up to 24 months after completion of study treatment
Incidence of adverse events
Will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to cemiplimab, according to the National Cancer Institute Common Terminology Criteria for Adverse events version 5.0. Safety and tolerability will be summarized by providing a frequency of adverse events by severity, type, timing and attribution.
Time frame: Up to 24 months after completion of study treatment
Quality of life (QOL)
Evaluate changes in quality of life per EORTC QLQ - THY34 questionnaire derived data which will be used to report QOL outcomes.
Time frame: Up to 24 months after completion of study treatment
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