PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma
United States36 participantsStarted 2022-02-07
Plain-language summary
The purpose of this research is to test the safety and effectiveness of the investigational combination of anti-Programmed Death (PD)-1 antibody therapy with or without LAG-3 inhibition (pembrolizumab or nivolumab+relatlimab) and infliximab in treating metastatic melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age greater than or equal to 18 years
* Participants must have histologically confirmed Stage III unresectable or Stage IV metastatic melanoma
* Patients should be treatment naïve and eligible for treatment with anti-PD-1 or anti-PD-1/LAG3 as a first line therapy (as selected by their treating physician)
* Patients previously treated for melanoma with surgical resection alone who present with recurrent Stage III unresectable or Stage IV metastatic melanoma are eligible for enrollment
* Patients who were previously treated with systemic neo-adjuvant or adjuvant anti-PD-1 therapy more than 6 months prior to study enrollment will be eligible. There are no restrictions to the use of prior BRAF targeted therapy.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan
* Diagnostic imaging studies such as MRIs and CT scans must be performed within 30 days of the date of registration
* Participants must have normal organ and marrow function as defined below:
* Leukocytes (WBC) \> 3,000/uL
* Absolute neutrophil count \> 1,500uL
* Platelets \> 100,000/uL
* Total bilirubin \< 1.5 X institutional upper limits of normal; total bilirubin \> 1.5X above institutional upper limits of normal will be allowed if direct bilirubin is within normal limits or if patients has a docume…
What they're measuring
1
Incidence of immune-related adverse events (irAE) in patients treated with anti-PD-1 plus infliximab compared to pembrolizumab plus placebo