Phase 4
Completed N=100
Study of Nivolumab for Advanced Cancers in India
Source: ClinicalTrials.gov NCT03444766 ↗Enrolled (actual)
100
Serious AEs
30.0%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events — 25; 4; 1 Count of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events |
25; 4; 1 | — |
| SECONDARY Number of Participants With Treatment-related Select Adverse Events |
1; 1; 1; 2; 1; 2 | — |
| SECONDARY Number of Participants With Treatment-related Serious Adverse Events |
4; 3; 1 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Discontinuation |
7; 5; 9; 0; 1 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
Exclusion Criteria
- Participants with untreated, symptomatic central nervous system (CNS) metastases
- Participants with carcinomatous meningitis
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Other active malignancy requiring concurrent intervention
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03444766). 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. Informational only — not medical advice.