Cemiplimab for NUT Carcinoma

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: PD-1, PD-L1 inhibitors

Disqualifiers: HIV, Hepatitis B, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 21 days per cycle, up to 32 cycles

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cemiplimab, an immunotherapy drug, to evaluate its effectiveness against NUT carcinoma, a rare and aggressive cancer with no current treatment. The goal is to help the immune system fight the cancer and prevent its growth and spread. Individuals with NUT carcinoma that has spread or cannot be surgically removed, and who lack other effective treatment options, might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received systemic therapy, radiation, or surgery within 14 days before starting the trial treatment. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that cemiplimab is likely to be safe for humans?

Earlier research has shown that cemiplimab is generally well-tolerated by patients. Some studies reported side effects, but these were mostly manageable. For example, patients sometimes experienced tiredness, skin rash, or diarrhea. Such side effects are common with many treatments that boost the immune system.

The FDA has already approved cemiplimab for other conditions, like certain skin cancers, indicating that its safety is well-understood. This knowledge helps doctors understand its effects on the body and identify potential side effects.

The current trial phase focuses on assessing the safety of cemiplimab specifically for NUT carcinoma. This phase typically indicates that the treatment has been safe enough in earlier studies to test in a larger group. While no treatment is without risk, ongoing research aims to ensure cemiplimab's safety for more patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it targets the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. Unlike traditional chemotherapy, which broadly attacks rapidly dividing cells, cemiplimab offers a more targeted approach by enhancing the body's own immune response specifically against NUT carcinoma. Researchers are excited about this treatment because it has the potential to provide a more precise and potentially less toxic alternative to standard treatments, which could lead to better outcomes and improved quality of life for patients.

What evidence suggests that cemiplimab might be an effective treatment for NUT carcinoma?

Research has shown that cemiplimab, a type of immunotherapy, may help treat NUT carcinoma, a rare and aggressive cancer. Studies on similar cancers have found that cemiplimab can assist the immune system in finding and destroying cancer cells. Evidence from related treatments suggests that patients might experience about 6.6 months without cancer progression. While specific results for cemiplimab in NUT carcinoma are still under investigation, early findings indicate that the drug interacts with target proteins in cancer cells, potentially slowing the disease's spread. Participants in this trial will receive cemiplimab as part of their treatment regimen. ^{1 3 5 6 7}

Who Is on the Research Team?

Jochen H Lorch, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for patients with an incurable type of cancer called NUT carcinoma that has spread or can't be surgically removed. Participants should have no available treatment options and must meet certain health standards.

Inclusion Criteria

Patients of child-bearing potential and their partners must agree to use adequate contraception.

Patients with sperm-producing reproductive capacity must agree to use adequate contraception.

Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab intravenously 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.

21 days per cycle, up to 32 cycles

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 3 months for 24 months.

24 months

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The study tests cemiplimab, a monoclonal antibody designed to boost the immune system's fight against cancer. It includes digital photography, biopsies, biospecimen collection, CT scans, MRIs, and questionnaires to monitor effects.

How Is the Trial Designed?

Group I: Treatment (cemiplimab) Experimental Treatment 7 Interventions

Patients 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. blog.dana-farber.org blog.dana-farber.org/insight/2020/01/new-studies-show-promise-in-treatment-of-nut-carcinoma/

New Studies Show Promise in Treatment of NUT Carcinoma At doses where there was evidence that the agent was reaching its target proteins within tumor cells, it was found to be safe. Of the 19 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07050186

NCT07050186 | Cemiplimab for the Treatment of Incurable ... 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 ...

3. withpower.com withpower.com/trial/phase-2-metastatic-nut-carcinoma-10-2025-82128

Cemiplimab for NUT Carcinoma This phase II trial studies how well cemiplimab works in treating patients with nuclear protein of testis (NUT) carcinoma for which no treatment is ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5361614/

Intensive treatment and survival outcomes in NUT midline ... Outcome data were available for 40 of 48 cases (Table 1). Median progression-free survival (PFS) was 6.6 months (range 4.7–8.4). Median overall ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8586

Efficacy profile of pembrolizumab for primary pulmonary ... The median overall survival (OS) was 7.3 months (95% CI: 5.2–8.8), and the median progression-free survival (PFS) was 4.6 months (95% CI: 3.1– ...

6. adisinsight.springer.com adisinsight.springer.com/trials/700384067

A Single Arm Open-Label Pilot Study to Investigate the Safety ... This phase II trial studies how well cemiplimab works in treating patients with nuclear protein of testis (NUT) carcinoma for which no treatment

7. ichgcp.net ichgcp.net/clinical-trials-registry/543225-cemiplimab-for-the-treatment-of-incurable-metastatic-or-unresectable-nut-carcinoma

Investigating Cemiplimab for Advanced NUT Carcinoma Phase 2 clinical trial investigating cemiplimab immunotherapy for adults with advanced NUT carcinoma, a rare aggressive cancer.