Purpose / Objectives

Primary Outcome

Primary Outcome Measures : Objective Response Rate (ORR)

Secondary Outcomes

Secondary Outcome Measures :

1. Duration of response (DOR)
2. ORR assessed by investigator
3. TTR
4. Clinical benefit rate (CBR)
5. Overall survival (OS)
6. PFS
7. Incidence of Adverse Events
8. Incidence of Serious Adverse Events
9. Incidence of laboratory abnormalities
10. Incidence of anti-drug antibody (ADA)

Diagnosis

• Solid Tumors

Patient attributes

Age

18-99

Inclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Refractory, metastatic, or unresectable TMB-H solid tumors who must have received at least one prior line of therapy including standard of care, if 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

Trial design

• Phase II
• Multicenter
• Prospective
• Randomized
• Two-arm
• Open Label

Intervention

Nivolumab versus Nivolumab/Ipilimumab

Documents (password protected)

Go to download area (no documents yet)

Responsibilities in overall trial

Sponsor

Bristol-Myers Squibb GmbH & Co. KGaA

• Tel. +49 (0) 89 - 12142 -0
• Fax +49 (0) 89 - 12142 -392

Study Sites