Actively Recruiting
Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma
Led by Northwestern University · Updated on 2025-09-29
15
Participants Needed
1
Research Sites
535 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed NUT carcinoma that is metastatic or unresectable without effective standard treatment
- May be treatment-naive or previously treated with surgery, radiation, or systemic therapy (exceptions apply)
- Confirmed NUT carcinoma by protein expression or gene translocation tests at certified labs
- Measurable disease by RECIST v1.1 criteria
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate blood counts: WBC 63 3,000/mcL, ANC 63 1,500/mcL, Hemoglobin 63 9 g/dL, Platelets 63 100,000/mcL
- Liver and kidney function within specified limits
- Glomerular filtration rate 63 40 mL/min/1.73 m�b2
- Patients with treated brain metastases stable on follow-up imaging
- Patients with new or progressive brain metastases if immediate treatment is not needed
- Agree to use effective contraception if of child-bearing potential or with a partner who has sperm-producing capacity
- Negative pregnancy test prior to study registration for patients of child-bearing potential
You will not qualify if you...
- Unable or unwilling to provide informed consent or comply with study requirements
- Prior treatment with PD-1 or PD-L1 inhibitors
- Received systemic therapy, radiation, or surgery within 14 days before treatment start
- Not recovered from side effects of prior cancer therapy greater than grade 1 (except alopecia, neuropathy, or minor effects)
- Receiving investigational agents or devices within 14 days before treatment
- History of allergic reactions to immune checkpoint inhibitors or similar antibody treatments
- Known HIV infection (unless on effective therapy with undetectable viral load for 6 months)
- Known chronic hepatitis B or C infection not controlled or cured
- Uncontrolled illness such as hypertension, active infection, heart failure, unstable angina, arrhythmia, or recent pneumonitis
- Psychiatric or social conditions limiting study compliance
- Prior allogeneic stem cell or organ transplant
- Significant autoimmune disease requiring immunosuppressive therapy within 5 years (some exceptions apply)
- Recent immune modulating agents within 4 weeks or associated with immune adverse events
- Pregnant or nursing patients of child-bearing potential
- Prior malignancy within 2 years that may interfere with study assessments (exceptions apply)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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