New drug combo aims to shrink advanced skin cancer tumors
NCT ID NCT03071406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding focused radiation to a two-drug immunotherapy combination works better than the drugs alone for people with advanced Merkel cell carcinoma, a rare and aggressive skin cancer. About 50 adults with cancer that has spread or cannot be removed will receive either nivolumab plus ipilimumab, or the same drugs plus stereotactic body radiation therapy. The main goal is to see how many patients' tumors shrink or disappear.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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Mar 2017
- Expected to finish
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Sep 2026
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: * At least 18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2 * Active disease measurable by CT, MRI or clinical exam. * Prior chemotherapy or immunotherapy will be allowed if new or persistent measurable site(s) of disease are present. * Prior radiation therapy will be allowed if there is active measurable disease burden. * Must be either recurrent, unresectable or Stage IV American Joint Committee on Cancer (AJCC) (7th edition) and have histologically confirmed Merkel cell carcinoma with at least 2 distinct lesions in order to be eligible. * Must have at least 2 distinct lesions as documented by a complete physical examination or imaging studies within 4 weeks prior to randomization. Imaging studies must include a diagnostic CT scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions). * Tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses. Exclusion Criteria: * History of Grade 3 toxicity or use of infliximab with prior immunotherapy * Patients with active brain metastasis. * Active, known, or suspected autoimmune disease. Potential participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. * Patients with prior history of non-Merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the patient is currently in complete remission per investigator's judgment; or patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible. * A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
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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.
Contacts and locations
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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