Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

Recruiting now · Phase 2

Conditions studied: Metastatic NUT Carcinoma, Unresectable NUT Carcinoma

In brief

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.

Key facts

Study ID

NCT07050186

Run by

Northwestern University

People needed

15

Starts

2025-08-15

Expected to finish

2035-11-20

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Patient may be treatment naïve or have had prior surgery, radiation, or any systemic therapy (with the exceptions noted in the Exclusion Criteria).
• 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.
• Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
• The effects of cemiplimab on the developing human fetus are unknown. For this reason and because immune checkpoint inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 6 months following completion of cemiplimab therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately.
• NOTE: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
• POCBP must have a negative pregnancy test prior to registration on study.
• Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 6 months after completion of administration.

You may not qualify if…

• Patients must have the ability to understand and the willingness to sign a written informed consent document prior to the start of any study activities (e.g. before screening/baseline activities and before registration on the study) and comply with the study requirements.
• Prior treatment with PD-1 or PD-L1 inhibitors.
• Received systemic therapy, radiation, or had surgery ≤ 14 days prior to planned treatment start date.
• NOTE: Prior therapy must meet requirements of criteria listed in Exclusion Criteria
• Patients who have not recovered from adverse events due to prior anti-cancer therapy, (i.e., have residual toxicities > grade 1 per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5) with the exception of alopecia, neuropathy, and other non-significant adverse events.
• Patients who are receiving any investigational agents or devices ≤ 14 days from planned start of treatment date.
• History of allergic reactions or acute hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to immune checkpoint inhibitors and/or to antibody treatments.
• Patients with a known history of Human immunodeficiency virus (HIV).
• NOTE: Infected patients on effective anti-retroviral therapy with an undetectable viral load for 6 months prior to start of study participation are eligible to participate.
• NOTE: CD4+ T cell counts and viral load are monitored per standard of care.
• Patients with a known history of chronic hepatitis B virus (HBV) infection.
• NOTE: Patients with HBV and an undetectable viral load on suppressive therapy are eligible to participate.
• NOTE: CD4+ T cell counts, and viral load are monitored per standard of care.
• Patients with a known history of hepatitis C virus (HCV) infection.
• NOTE: For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load OR
• NOTE: Patients with an HCV infection must have been treated and cured in order to participate.
• NOTE: CD4+ T cell counts, and viral load are monitored per standard of care.
• Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
• Hypertension that is not controlled on medication
• Ongoing or active infection requiring systemic treatment
• NOTE: Prophylactic antibiotic treatment is allowed (e.g. for uncomplicated infections such as urinary tract infections [UTIs] or sinus infections being treated with oral antibiotics)
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• History of pneumonitis within the last 5 years

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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