Is NCT07050186 recruiting in Chicago, IL?

Yes, NCT07050186 is currently recruiting participants at its Chicago, IL location. This metastatic nut carcinoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic nut carcinoma clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic NUT Carcinoma Clinical Trial in Chicago, IL

About This Metastatic NUT Carcinoma Study in Chicago

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.

Sponsor: Northwestern University

Who Can Participate

Inclusion Criteria

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. Exclusion Criteria:

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

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:

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT07050186) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic NUT Carcinoma Treatment Options in Chicago, IL

If you're searching for metastatic nut carcinoma treatment options in Chicago, IL, this clinical trial (NCT07050186) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced metastatic nut carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic nut carcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic NUT Carcinoma Clinical Trial in Chicago, IL

Expert Care in Chicago

IRB Approved

No-Cost Care

Apply for This Chicago Location

Why Participate?

Simple Process