Recruiting
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) - CA209-848
Updated: 26 June, 2020 | ClinicalTrials.gov
Print Friendly Summary
Trial Details
Phase
Gender(s)
Age Range
Location(s)
Recruiting
Treatment Options
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with TMB-H who are refractory to standard local therapies, or for which no standard treatment is available. - Available tumor tissue and blood for TMB testing - Participants must have measurable disease for response assessment Exclusion Criteria: - Women with positive pregnancy test at enrollment or prior administration of study medication - Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease - Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment Other protocol defined inclusion/exclusion criteria could apply
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
