Description:
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)
Title
- Brief Title: 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)
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
CA209-848
- SECONDARY ID:
2016-002898-35
- NCT ID:
NCT03668119
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | Opdivo, BMS-936558 | Nivolumab + Ipilimumab Combination |
| Ipilimumab | Yervoy, BMS-734016 | Nivolumab + Ipilimumab Combination |
Purpose
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)
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab + Ipilimumab Combination | Experimental | | |
| Nivolumab Monotherapy | Experimental | | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 12 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Objective Response Rate (ORR) in the Tissue Tumor Mutational Burden (tTMB-H) Population |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Duration of response (DOR) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time To Response (TTR) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Clinical benefit rate (CBR) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival (OS) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Serious Adverse Events (SAEs) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of AEs leading to discontinuation |
| Time Frame: | Approximately 3 Years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Deaths |
| Time Frame: | Approximately 3 Years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of laboratory abnormalities |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of anti-drug antibody (ADA) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
Last Updated
November 17, 2020
