Clinical trial · Interventional
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination With Retifanlimab or Tebotelimab in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT04634825CI-TRIAL-00072439terminatedPhase 2Results postedClinicalTrials.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): Based on internal review of safety data
Summary
Brief summary (as posted)
This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Conditions
Conditions (3)
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 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoblituzumab | Biological | — | UNRESOLVED |
| Retifanlimab | Biological | Retifanlimab | ALIAS |
| Tebotelimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Retifanlimab Cohort
- description
- Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
- interventionNames
- Biological: Enoblituzumab
- Biological: Retifanlimab
- type
- EXPERIMENTAL
- label
- Tebotelimab Cohort
- description
- Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
- interventionNames
- Biological: Enoblituzumab
- Biological: Tebotelimab
Primary outcomes (3)
- measure
- Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) not curable by local therapy * No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior if given as part of multimodal treatment for locally advanced disease) * Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx (any histology) * Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest * Willing to consent for baseline and on-treatment biopsy. * Performance status 0 or 1 * Life expectancy of 6 months or more * Adequate end organ function * At least one radiographically measurable lesion * PD-L1 expression level that is either 1. Positive (combined positive score \[CPS\] ≥ 1) for the retifanlimab cohort, or 2. Negative (CPS \< 1) for the tebotelimab cohort * Results available from human papilloma virus p16 status for oropharyngeal cancer * Acceptable laboratory results Exclusion Criteria: * Disease suitable for local therapy administered with curative intent * Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN * Radiation or other non-systemic therapy within 2 weeks prior to the first dose of study drug * Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
References
Publications (0)
Data not yet available
No reference posted for this study.