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New treatment option for Metastatic NUT Carcinoma
Official title Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma
ClinicalTrials.gov ID: NCT07050186
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic nut carcinoma.
Also referred to as Cemiplimab RWLC, Cemiplimab-rwlc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have a histologically confirmed NUT carcinoma that is metastatic or unresectable and for which standard curative or palliative measures...
- Patient may be treatment naïve or have had prior surgery, radiation, or any systemic therapy (with the exceptions noted in the
You likely can't join if
- Patients must have histologically or cytologically confirmed NUT carcinoma based on the ectopic expression of NUT protein per World Health...
- 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.
See the full eligibility criteria
Who can 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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]...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.