Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma
NCT07050186 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-09-29
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
Interventions
- PROCEDURE
-
Biopsy Procedure
Undergo optional biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood samples
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Computed Tomography
Undergo CT
- OTHER
-
Digital Photography
Undergo digital photography
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Jochen H Lorch, MD · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-15
- Primary Completion
- 2030-11-20
- Completion
- 2035-11-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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