CLINICAL TRIALS

Whether a clinical trial is right for you is a personal decision that depends on many factors. We’re here to help you understand your options and support you every step of the way, whatever you decide.

What is a Phase 1 Clinical Trial?

Hearing the term “Phase 1 clinical trial” after a rare diagnosis like NUT carcinoma can feel overwhelming—but it doesn’t have to be. A Phase 1 trial is simply the first step in testing a new treatment in people after it has shown promise in the lab. The focus is on finding the right dose and understanding side effects, and while the primary goal isn’t to prove effectiveness yet, many patients do benefit from these early-stage therapies.

For rare cancers like NUT carcinoma, where current treatment options are limited, clinical trials may offer access to targeted therapies designed specifically for this disease. Patients in these trials are cared for by experts who specialize in rare cancers and are closely monitored throughout the process, offering both hope and high-quality care.

fork in the road with two signs that say "Standard Protocol" going one way and "Clinical trial" in another

Frequently Asked Questions

Who is running clinical trials for NUT carcinoma?

All current NUT carcinoma clinical trails can be found here clinicaltrials.gov

Details of some of the open clinical trails are are described below:

Dana-Farber Cancer Institute is leading multiple clinical trials, including:

Each trial targets different aspects of NUT carcinoma biology, with the goal of finding more effective treatments for this rare and aggressive cancer.
 A current list of NUT carcinoma clinical trials led by Dana Farber can be found at the NUT Carcinoma Registry website.

University of North Carolina at Chapel Hill is a clinical trail site for a T-Scan Therapeutics treatment which tries to use the body’s own immune system to attack NUT carcinoma. 

Potentially interested candidates are first enrolled in a screening trial, to evaluate fit between the patient’s immune type (HLA type) and the treatment as well as between the cancer and the treatment (making sure that the cancer is showing the foreign elements that the product helps the immune system to attack).

Northwestern University is leading a cemiplimab phase II clinical trial for patients with NUT carcinoma 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 vary by trial, but common requirements include:

  1. Age requirements:
    • Most trials accept adults of any age
    • Some trials include adolescents aged 12-17 (typically weighing at least 40kg)
    • Children under 12 are generally not eligible for current trials
  2. Diagnosis confirmation:
    • Confirmed diagnosis of NUT carcinoma (usually by positive NUT protein testing)
    • Some trials focus on specific subtypes (like non-BRD4 fusions)
    • Some trials accept patients with other cancer types besides NUT carcinoma
  3. Health status:
    • Adequate organ function (liver, kidneys, bone marrow)
    • Reasonable performance status (ability to perform daily activities)
    • No uncontrolled medical conditions
  4. Prior treatments:
    • Some trials accept newly diagnosed patients
    • Others require that standard treatments have been tried first

Each trial has its own specific criteria. For detailed eligibility information, speak with your healthcare provider or contact the clinical trial coordinators directly.

The process for enrolling in a NUT carcinoma clinical trial typically involves these steps:

  1. Initial diagnosis confirmation: You must have a confirmed diagnosis of NUT carcinoma, usually through NUT protein testing by immunohistochemistry.
  2. Referral options:
    • You can be referred by your current oncologist to Dana-Farber or another institution running trials
    • You can self-refer by contacting Dana-Farber’s clinical trials office directly
    • You don’t need to be an existing Dana-Farber patient to participate in their trials
  3. Screening process:
    • The clinical trial team will review your medical records and pathology reports
    • Additional testing may be needed to determine eligibility (blood tests, imaging, etc.)
    • Your tumor tissue may be tested for specific genetic alterations
  4. Insurance and financial considerations:
    • Insurance coverage for clinical trials varies by plan and state
    • Many research costs are covered by the trial sponsor
    • Standard care costs (visits, routine tests) are typically billed to insurance
    • Financial counselors at Dana-Farber can help navigate coverage questions
  5. Informed consent:
    • You’ll meet with the research team to discuss the trial in detail
    • The risks, benefits, and alternatives will be explained
    • You’ll have time to ask questions before deciding to participate

For specific guidance on enrolling in a NUT carcinoma trial at Dana-Farber, you can contact their clinical trials office at 877-338-7425 or visit their website to search for available trials.

Joining a NUT carcinoma clinical trial offers several potential benefits:

  1. Access to cutting-edge treatments not yet widely available, including targeted therapies specifically designed for NUT carcinoma’s unique biology
  2. Specialized care from experts who focus on this rare cancer, including teams at leading institutions with experience treating NUT carcinoma
  3. Comprehensive monitoring with frequent check-ups and detailed assessments that may be more thorough than standard care
  4. Contributing to research that may help future patients with this rare disease, potentially leading to better treatments or improved understanding of NUT carcinoma
  5. Potential for better outcomes than might be achieved with standard treatments, which have limited effectiveness against NUT carcinoma
  6. No or reduced costs for the experimental treatment and related tests, as these are typically covered by the trial sponsor
  7. Support services specifically designed for trial participants, including assistance with logistics, understanding the trial process, and managing side effects

While clinical trials aren’t guaranteed to benefit every participant, they represent an important treatment option for a rare cancer with limited standard treatment options.

Still Have Questions?

Feel free to reach out and message us and we will do our best to connect you with the answer.

Message Us