Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Patient may be treatment naïve or have had prior surgery, radiation, or any systemic therapy (with the exceptions noted in the
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Cemiplimab
- Computed Tomography
- Digital Photography
- Magnetic Resonance Imaging
- Questionnaire Administration
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov