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Metastatic NUT CarcinomaPhase 2NCT07050186

Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Cemiplimab in people with Metastatic NUT Carcinoma and Unresectable NUT Carcinoma, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Cemiplimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
15 Aug 2025to 20 Nov 2035
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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
  • Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients have received a prior allogeneic stem cell transplant or received an organ transplant.
  • Patients have ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune mediated adverse events (imAEs).
  • NOTE the following are not exclusionary:
  • Vitiligo,
  • Childhood asthma that has resolved,
  • Type 1 diabetes,
  • Residual hypothyroidism that required only hormone replacement,
  • Psoriasis that does not require systemic treatment.
  • And the following medications:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);
  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Patients that received prior treatment with other immune modulating agents that was:
  • Less than 4 weeks (28 days) prior to the first dose of cemiplimab, or
  • Associated with imAEs that were grade ≥ 1 within 90 days prior to the first dose of cemiplimab, or
  • Associated with toxicity that resulted in discontinuation of the immune-modulating agent.
  • Patients of child-bearing potential (POCBP) who are pregnant or nursing.
  • NOTE: POCBP that are pregnant or are nursing are excluded from this study; cemiplimab is an immune checkpoint inhibitor agent with potential for teratogenic or abortifacient effect. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cemiplimab; breastfeeding should be discontinued if the patient is a nursing parent treated with cemiplimab.
  • Patient with a current or prior malignancy within the previous 2 years and in the opinion of the treating investigator would interfere with monitoring of radiological assessments of response to cemiplimab. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Incidentally diagnosed prostate cancer is also allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

312-695-1301

cancertrials@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Jochen H. Lorch, 312-694-6959, jochen.lorch@nm.org

    Jochen H. Lorch

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biopsy Procedure, Biospecimen Collection, Cemiplimab, Computed Tomography, Digital Photography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo optional biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Digital PhotographyOther

    Undergo digital photography

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07050186
Study groupRoleWhat they receive
Treatment (cemiplimab)ExperimentalPatients 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Other: Digital Photography; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall response rate (ORR)

    Will calculate the proportion of treated patients who experience an objective response (confirmed complete response [CR] or confirmed partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1). The date of first response for either CR or PR will be used for the calculation of ORR. The proportion of evaluable patients experiencing an objective response will be estimated with a 95% exact binomial CI. The confidence interval will be adjusted for the sequential nature of the two-stage procedure.

    Measured: Up to 24 months after completion of study treatment

  2. Duration of response (DOR)

    Response is defined as confirmed CR or confirmed PR per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using descriptive statistics, and the CR rate of nuclear protein of testis carcinoma in patients will be determined.

    Measured: 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

  3. Clinical response rate

    Will calculate the proportion of treated, evaluable patients who experience clinical benefit from trial therapy. Clinical benefit is defined as confirmed CR; confirmed PR; or stable disease for ≥ 6 months per RECIST 1.1. Will be estimated with a proportion and CI.

    Measured: 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

  4. OS

    Will be analyzed using the Kaplan-Meier method. The median OS estimate will be reported along with the CI.

    Measured: 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

  5. Incidence of adverse events

    Will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to cemiplimab, according to the National Cancer Institute Common Terminology Criteria for Adverse events version 5.0. Safety and tolerability will be summarized by providing a frequency of adverse events by severity, type, timing and attribution.

    Measured: Up to 24 months after completion of study treatment

  6. Quality of life (QOL)

    Evaluate changes in quality of life per EORTC QLQ - THY34 questionnaire derived data which will be used to report QOL outcomes.

    Measured: Up to 24 months after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start15 Aug 2025
  3. Primary completion20 Nov 2030 (estimated)
  4. Study completion20 Nov 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050186
Sponsor's protocol ID
NU 24N03
Other IDs
NCI-2025-03799, NU 24N03, P30CA060553
Status last verified
Aug 2026
First submitted
25 Jun 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Cemiplimab in people with Metastatic NUT Carcinoma and Unresectable NUT Carcinoma, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (312-695-1301, cancertrials@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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