Clinical trial · Interventional
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
NCT03048136CI-TRIAL-00032536CheckMate 955withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objective has changed
Summary
Brief summary (as posted)
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flat-Dose
- description
- Nivolumab flat dose + Ipilimumab
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- EXPERIMENTAL
- label
- Weight-Based Dose
- description
- Nivolumab weight-based dose + Ipilimumab
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
Primary outcomes (2)
- measure
- Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 1\) Stage IV or recurrent non-Small cell lung cancer * 2\) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * 3\) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization Exclusion Criteria: * 1\) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy * 2\) Active, known or suspected autoimmune disease or HIV infection * 3\) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors) * 4\) Untreated Central Nervous System metastases Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.