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)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/9/2019 |
| Start Date: | October 29, 2018 |
| End Date: | September 8, 2023 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
| Email: | Clinical.Trials@bms.com |
| Phone: | please email: |
A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab
alone is effective and safe in the treatment of solid tumors with High Tumor Mutational
Burden (TMB-H)
alone is effective and safe in the treatment of solid tumors with High Tumor Mutational
Burden (TMB-H)
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:
- 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 found this trial at
29
sites
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