NCT07050186

Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

A Single Arm Open-Label Pilot Study to Investigate the Safety and Clinical Activity of Cemiplimab, A Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Incurable NUT Carcinoma (NC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic NUT Carcinoma
• Unresectable NUT Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo optional biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
BIOLOGICAL	Cemiplimab	Given IV
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Digital Photography	Undergo digital photography
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-08-15
• Primary completion: 2030-11-20
• Completion: 2035-11-20
• First posted: 2025-07-03
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study