Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 for TMB-H testing - Participants must have measurable disease for response assessment Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
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-PDL1, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To compare BICR-assessed objective response rate (ORR) in participants of tTMB-H treated with nivolumab combined with ipilimumab with a historical control -To compare BICR-assessed ORR in participants of bTMB-H treated with nivolumab combined with ipilimumab with a historical control ; Secondary Objective: To assess: - BICR-assessed duration of response (DOR) and time to response (TTR) in tTMB-H or bTMB-H patients treated with nivo + ipi - BICR-assessed ORR, DOR and TTR in tTMB-H or bTMB-H patients treated with nivo alone - Investigator-assessed ORR, DOR, TTR in tTMB-H or bTMB-H patients treated with nivo + ipi and nivo alone - BICR- and investigator-assessed clinical benefit rate (CBR) in tTMB-H or bTMB-H patients treated with nivo + ipi and nivo alone - BICR- and investigator-assessed progression free survival (PFS) in tTMB-H or bTMB-H patients treated with nivo + ipi and nivo alone - Overall Survival (OS) in tTMB-H or bTMB-H patients treated with nivo +ipi and nivo alone - overall safety and tolerability ; Primary end point(s): -BICR-assessed ORR using RECIST 1.1, and Response Assessment for Neuro-Oncology (RANO) criteria in primary CNS tumors -BICR-assessed ORR using RECIST 1.1, and RANO criteria in primary CNS tumors ;Timepoint(s) of evaluation of this end point: Approximately 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -BICR-assessed DOR -BICR-assessed TTR -BICR-assessed ORR -Investigator-assessed ORR -Investigator-assessed DOR -Investigator-assessed TTR -BICR-assessed CBR -Investigator-assessed CBR -BICR-assessed PFS -Investigator-assessed PFS -Overall survival -AEs, clinical laboratory values, or other safety biomarkers ;Timepoint(s) of evaluation of this end point: Approximately 3 years | — |
Countries
Argentina, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Romania, Singapore, Spain, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed