Phase 2
N=212
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)
Pan Tumor
Bottom Line
View on ClinicalTrials.gov: NCT03668119 ↗Enrolled (actual)
212
Serious AEs
60.1%
Results posted
May 2023
Primary outcome: Primary: Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A — 22.5; 38.6 Precentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A |
22.5; 38.6 | — |
| SECONDARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B |
15.6; 29.8 | — |
| SECONDARY Objective Response Rate (ORR) Per Investigator |
25.0; 13.3; 44.3; 23.4 | — |
| SECONDARY Duration of Response (DoR) Per Investigator |
27.96; NA; NA; NA | — |
| SECONDARY Duration of Response (DoR) Per Blinded Independent Central Review (BICR) |
NA; NA; NA; NA | — |
| SECONDARY Time to Objective Response (TTR) Per Investigator |
3.48; 4.08; 3.56; 3.75 | — |
| SECONDARY Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR) |
3.59; 4.33; 4.37; 3.98 | — |
| SECONDARY Clinical Benefit Rate (CBR) Per Investigator |
42.5; 40.0; 63.6; 46.8 | — |
| SECONDARY Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR) |
32.5; 28.9; 53.4; 38.3 | — |
| SECONDARY Progression Free Survival (PFS) Per Investigator |
2.99; 3.04; 8.15; 3.06 | — |
| SECONDARY Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) |
2.83; 2.83; 5.68; 2.83 | — |
| SECONDARY Overall Survival (OS) |
8.07; 11.24; 16.48; 14.59 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
82; 46; 93; 50; 51; 17 | — |
| SECONDARY Number of Participants With On-Treatment Laboratory Parameters |
6; 3; 8; 7; 1; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03668119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.