Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

NCT07050186 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: NU 24N03NCI-2025-03799P30CA060553
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic NUT Carcinoma; Unresectable NUT Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall 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.

  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.

Secondary Outcomes (6)

• Overall response rate (ORR)

  Up to 24 months after completion of study treatment

• Duration of response (DOR)

  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

  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

  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

  Up to 24 months after completion of study treatment

Study Arms (1)

Treatment (cemiplimab)

EXPERIMENTAL

Patients receive cemiplimab 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 CT, MRI, and/or digital photography as well as blood sample collection and optional tumor biopsies throughout the study.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Other: Digital Photography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Biopsy Procedure PROCEDURE

Undergo optional biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (cemiplimab)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (cemiplimab)

Cemiplimab BIOLOGICAL

Given IV

Also known as: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810, REGN-2810, REGN2810

Treatment (cemiplimab)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (cemiplimab)

Digital Photography OTHER

Undergo digital photography

Treatment (cemiplimab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (cemiplimab)

Questionnaire Administration OTHER

Ancillary studies

Treatment (cemiplimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed NUT carcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.

You may not qualify if:

• Patients must have histologically or cytologically confirmed NUT carcinoma based on the ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) and/or detection of NUT gene translocation as determined by fluorescence in situ hybridization (FISH) at a Clinical Laboratory Improvement Act (CLIA) certified laboratory and/or by detection of the NUT gene translocation as determined by sequencing (e.g., deoxyribonucleic acid \[DNA\] next generation sequencing \[NGS\] or ribonucleic acid \[RNA\] sequencing) at a CLIA certified laboratory.
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
• Patients must be age ≥ 18 years.
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Leukocytes (WBC) ≥ 3,000/mcL.
• Absolute neutrophil count (ANC) ≥ 1,500/mcL.
• Hemoglobin (Hgb) ≥ 9 g/dL.
• Platelets (PLT) ≥ 100,000/mcL.
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 3 x institutional ULN.
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional ULN.
• Creatinine ≤ 1.5 x institutional ULN.
• Glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m\^2.
• Estimated (e)GFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Biopsy; Specimen Handling; cemiplimab; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jochen H Lorch, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

312-695-1301; cancertrials@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): November 20, 2030
• Study Completion (Estimated): November 20, 2035
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)