A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Me… (NCT03668119) | Clinical Trial Compass
CompletedPhase 2
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)
United States212 participantsStarted 2018-10-31
Plain-language summary
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
* Must be able to provide tissue and blood TMB-H testing results
* Must have measurable disease for response assessment
Exclusion Criteria:
* 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-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (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 apply.
What they're measuring
1
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Timeframe: From date of randomization up to 42 months