Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma (NCT01585194) | Clinical Trial Compass
CompletedPhase 2
Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma
United States67 participantsStarted 2012-11-29
Plain-language summary
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with uveal melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to give written informed consent
* History of uveal melanoma and documented metastatic disease with at least one measurable lesion is required; which is \>= 1 cm x 1 cm (on spiral computed tomography \[CT\] or equivalent)
* Any number of prior therapies is allowed
* White blood cell (WBC) \>= 2000/uL
* Absolute neutrophil count (ANC) \>= 1500/uL
* Platelets \>= 100 x 10\^3/uL
* Hemoglobin \>= 9 g/dL
* Creatinine =\< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) \> 40 mL/min (using the Cockcroft-Gault formula)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN for patients without liver metastasis, =\< 5 x ULN for liver metastases
* Bilirubin =\< 1.5 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
* In suspected patients no active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
* Baseline imaging in the form of CT chest, abdomen, pelvis with oral and intravenous contrast within 28 days of study entry; for patients with a contrast allergy, choice of alternative body imaging will be at the discretion of the investigator or his designee; magnetic resonance imaging (MRI) of the brain is only needed if clinically indicated
* Prior to start of treatment must be more than 21 days elapsed from surgery, radiation therapy, or prior chemothera…
What they're measuring
1
Overall Response Rate, Defined Per RECIST 1.1
Timeframe: Up to 2 years of treatment plus 60 days from last study dose