A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
Acral Lentiginous Melanoma, Mucosal Melanoma
About this trial
This is an interventional treatment trial for Acral Lentiginous Melanoma focused on measuring Melanoma, Mucosal, Acral Lentiginous, Ipilimumab, Nivolumab, Anti-tumor, Potential Predictors, Opdivo, Yervoy
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed MCM or ALM that is metastatic or unresectable.
- Patients must be eligible to receive nivolumab in combination with ipilimumab treatment per institutional guidelines.
- Patients must have a tissue block (or 20 unstained slides) available with adequate tumor to perform multiplex immunohistochemistry and nucleic acids analyses ( i.e. whole exome sequencing) Patients with only a previous fine-needle aspirate are ineligible for enrollment.
- Patients must be willing to donate a small amount of whole blood prior to treatment and during treatment for laboratory analysis.
- Patients must give informed consent prior to initiation of therapy.
- Patients must be ambulatory with good performance status (ECOG 0 or 1)
Exclusion Criteria:
- Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses.
- Patients who have received prior immunotherapy for unresectable or metastatic disease.
- Patients with untreated brain metastases, leptomeningeal disease, or seizure disorders are ineligible. Patients with a history of brain metastases must have completed treatment (i.e. surgery or radiation) 1 month prior to enrollment and have no evidence of disease or edema on brain CT or head MRI.
- Patients with inadequate tissue for analysis.
Sites / Locations
- Lombardi Comprehensive Cancer Center
- Washington Cancer Institute at MedStar Washington Hospital Center
- H. Lee Moffitt Cancer Center and Research Institute
- John Theurer Cacner Center at Hackensack University Medical Center
Arms of the Study
Arm 1
Experimental
Nivolumab-Ipilimumab Combination Therapy
All patients will receive nivolumab administered IV over 60 minutes at 1 mg/kg combined with ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks until progression, intolerable toxicity, or a maximum of 48 weeks, whichever comes first (Maintenance). Patients exhibiting complete response (CR) should continue nivolumab monotherapy at least 12 weeks beyond documentation of CR, if possible.