Immune cell attack: new combo therapy targets brain tumors in advanced melanoma
NCT ID NCT05588453
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for people with stage IV melanoma that has spread to the brain. It combines a chemotherapy drug (temozolomide) with specially grown immune cells (NK cells) from a healthy donor. The goal is to see if this combination is safe and can shrink brain tumors. About 24 participants will take part in this early-phase trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed melanoma with stage IV disease * Radiologically confirmed brain metastasis (n \>= 1) with at least one measurable central nervous system (CNS) lesion \>= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression * No indication for stereotactic radiotherapy * At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation) * Absolute neutrophil count (ANC) 1 x 10\^9/L * Platelets \> 100,000/L * Hemoglobin (Hgb) \>= 10 g/dL * Creatinine =\< 1.5 x upper limit of normal (ULN) * Albumin \>= 2.5 g/dL * Serum bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN if documented liver metastases or \< 3 X ULN without liver metastasis * \> 18 years old (y/o) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Females of reproductive age must agree to the use of an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of contraception or completely abstain from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment * Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the first study treatment * Patient information and written informed consent form signed Exclusion Criteria: * Planned or concurrent systemic treatment or radiation therapy * If requiring corticosteroids for cerebral edema, patients must be on a stable dose. Lowest dose of steroids needed to control CNS edema is recommended. Doses above 4 mg daily need to be cleared by principal investigator (PI) of the study * Known contra-indication to MRI * Patients with non-melanoma malignancies are excluded unless a complete remission has been achieved at least 3 years prior to study entry and no additional therapy is required or anticipated during the study period (exceptions include: non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer, in situ colon cancers, in situ cervical cancers/dysplasia, or in situ breast carcinoma) * Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: * Active infection * Current active hepatic or renal disease * Pregnant women, women who are likely to become pregnant or are breastfeeding * Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological, or geographical conditions potentially hampering ability to consent, compliance with the study protocol, and follow-up schedule; those conditions should be discussed with the patient before remigration in the trial * Patients who received any other investigational drugs within the 30 days prior to screening visit * Leptomeningeal metastases diagnosed by MRI * Inclusion in another therapeutic protocol within 30 days * If steroids are necessary to control symptoms related to CNS metastases, patients should be on the lowest dose of steroids necessary to control symptoms
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can a memory drug and precision radiation save thinking during brain cancer treatment?
- Can an immune booster make chemo hit melanoma harder?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy