Clinical trial · Interventional
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
NCT02869789CI-TRIAL-00067169completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab in combination with Ipilimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab in combination with Ipilimumab
- description
- Specified dose on specified days
- interventionNames
- Drug: Nivolumab in combination with Ipilimumab
Primary outcomes (2)
- measure
- Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
- timeFrame
- From first dose to 30 days post last dose (Up to approximately 27 months)
- description
- Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Stage 4 or recurrent non-small cell lung cancer * Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer) * No prior systemic anticancer therapy (including EGFR and ALK inhibitors) * Tissue or Programmed death-ligand 1 (PD-L1) results available Cohort 1A Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) score 2 or * Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria: * High Tumor Mutation Burden Exclusion Criteria: * Untreated brain metastases * An active malignancy that requires concurrent intervention * Active, known or suspected autoimmune disease * Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer Other protocol-defined inclusion/exclusion criteria apply
References
Publications (1)
- DERIVEDReady NE, Audigier-Valette C, Goldman JW, Felip E, Ciuleanu TE, Rosario Garcia Campelo M, Jao K, Barlesi F, Bordenave S, Rijavec E, Urban L, Aucoin JS, Zannori C, Vermaelen K, Aren Frontera O, Curioni Fontecedro A, Sanchez-Gastaldo A, Juan-Vidal O, Linardou H, Poddubskaya E, Spigel DR, Ahmed S, Maio M, Li S, Chang H, Fiore J, Acevedo A, Paz-Ares L. First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817. J Immunother Cancer. 2023 Feb;11(2):e006127. doi: 10.1136/jitc-2022-006127. PMID 36725084