Clinical trial · Interventional
Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer
A Phase Ib Trial of Concurrent Cetuximab (ERBITUX®) and Intensity Modulated Radiotherapy (IMRT) With Ipilimumab (YERVOY®) in Locally Advanced Head and Neck Cancer
- 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)
This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7 | Head and Neck Squamous Cell Carcinoma | PROBABILISTIC | 0.70 |
| Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7 | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7 | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 | Oropharyngeal Squamous Cell Carcinoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cetuximab, IMRT, and ipilimumab)
- description
- Patients receive cetuximab IV over 60-120 minutes on days 1, 8, 15, and 22. Treatment with cetuximab repeats every 4 weeks for 2 courses. Beginning in week 2 of course 1, patients undergo concurrent IMRT 5 days per week for 7 weeks. Beginning in week 4 (day 1 of course 2) patients also receive ipilimumab IV over 90 minutes once every 21 days for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may undergo surgery after completion of therapy.
- interventionNames
- Biological: Cetuximab
- Radiation: Intensity-Modulated Radiation Therapy
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Proportion of dose limiting toxicities at each dose level assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
- timeFrame
- Up to 12 weeks
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * American Joint Committee on Cancer (AJCC) stage III/IVB, excluding T1N1, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the head and neck; patients should not have distant metastasis; primary sites include: oropharynx, hypopharynx, larynx * Patients must have high or intermediate risk disease, defined as follows: * High risk: non-oropharyngeal subsite including larynx or hypopharynx (p16 status not required) or human papilloma virus (HPV)/p16- oropharynx subsite * Intermediate risk: HPV/p16+ oropharyngeal squamous cell cancer with: \>= 10 pack (pk)-year (yr) smoking history and \>= N2 nodal disease, or the presence of T4 tumor or N3 nodal disease, irrespective of smoking status * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients should be newly diagnosed HNSCC, with no prior therapy for this disease * Eastern Cooperative Oncology Group (ECOG) performance status typically =\< 1 (Karnofsky \>= 70%) * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,200/mcL * Platelets \>= 75,000/mcL * Total bilirubin =\< 2 mg/dL (=\< 3 mg/dL in case of Gilbert's syndrome) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2 times institutional upper limit of normal (IULN) * Creatinine clearance \>= 40 mL/min/1.73 m\^2 * Patients must have the ability to understand and to sign written informed consent Exclusion Criteria: * Patients who have had prior chemotherapy, radiotherapy, or surgery with curative intent for HNSCC * Patients with a history of prior treatment with ipilimumab, anti-programmed cell death 1 (PD 1) antibody, cluster of differentiation 137 (CD137) agonist or other immune activating therapy such as anti-cluster of differentiation 40 (CD 40) antibody * Patients who are receiving any other investigational agents * Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic non-gastrointestinal autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis) * Patients with known immunodeficiency disorder, or presumed to be unable to respond to anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA 4) monoclonal antibody (mAb) * Patients with distant metastatic disease (stage IVC) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or ipilimumab * Patient is \< 2 years free from a second primary malignancy unless the other malignancy is non-melanomatous skin cancer or an in-situ tumor treated with curative intent * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients with chronic hepatitis B or hepatitis C infections are excluded * Pregnant women are excluded from this study * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
References
Publications (1)
- DERIVEDFerris RL, Moskovitz J, Kunning S, Ruffin AT, Reeder C, Ohr J, Gooding WE, Kim S, Karlovits BJ, Vignali DAA, Duvvuri U, Johnson JT, Petro D, Heron DE, Clump DA, Bruno TC, Bauman JE. Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1335-1344. doi: 10.1158/1078-0432.CCR-21-0426. PMID 35091445