Clinical trial · Interventional
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
NCT02823574CI-TRIAL-00066086CheckMate 714completedPhase 2Results 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 in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab and Ipilimumab
- description
- Specified dose on specified days
- interventionNames
- Biological: Nivolumab
- Biological: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- Nivolumab and Ipilimumab-placebo
- description
- Specified dose on specified days
- interventionNames
- Biological: Nivolumab
- Other: Placebo
Primary outcomes (3)
- measure
- Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed squamous cell head and neck cancer * Widespread (metastatic) disease, or returned after previous treatment (recurrent) * Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV \[Human Papilloma Virus (oropharynx only)\] * Performance status ECOG 0-1 (Eastern Cooperative Oncology Group) Exclusion Criteria: * Previous treatment for metastatic or recurrent disease * Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin * Any non-squamous subtype * Active autoimmune disease * Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus * Previous treatment with checkpoint inhibitor drugs * Active CNS metastases or carcinomatous meningitis Other protocol-defined inclusion/exclusion criteria apply
References
Publications (1)
- DERIVEDHarrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147. PMID 37022706