Phase 2
N=239
An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02832167 ↗Enrolled (actual)
239
Serious AEs
61.9%
Results posted
Dec 2020
Primary outcome: Primary: Objective Response Rate (ORR) — 7.9 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
7.9 | — |
| SECONDARY Duration of Response (DOR) |
21.78 | — |
| SECONDARY Time to Objective Response (TTR) |
3.54 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
49.8 | — |
| SECONDARY Overall Survival Rate at 1 Year |
56.1 | — |
| SECONDARY Number of Participants Who Died |
72 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) |
234 | — |
| SECONDARY Number of Participants Experiencing Serious Adverse Events (SAEs) |
148 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
41 | — |
| SECONDARY Number of Participants Experiencing Immune-mediated Adverse Events (IMAEs) |
8 | — |
| SECONDARY Number of Participants Experiencing Select Adverse Events |
57; 33; 6; 22; 59; 7 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AEs) Leading to Dose Delay or Dose Reduction |
61 | — |
| SECONDARY Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests |
11; 8; 3; 1; 5; 3 | — |
| SECONDARY Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests |
62; 42; 12; 0; 2; 38 | — |
Summary
The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced or metastatic malignancy
- Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
- Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
- Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
- Subjects with an active, known, or suspected autoimmune disease
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02832167). 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.