Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma (NCT03071406) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma
United States50 participantsStarted 2017-03-14
Plain-language summary
The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. This study will test an investigational use of nivolumab.
Who can participate
Age range18 Years
SexALL
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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, psori…
What they're measuring
1
Best Overall Response
Timeframe: Up to 18 months
Trial details
NCT IDNCT03071406
SponsorH. Lee Moffitt Cancer Center and Research Institute