Clinical trial · Interventional
Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial was terminated by sponsor due to lack of efficacy.
Summary
Brief summary (as posted)
This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Patritumab | Drug | Patritumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patritumab
- description
- All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
- interventionNames
- Drug: Patritumab
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)
- interventionNames
- Drug: Cetuximab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx * Has or be willing to provide tumor tissue for testing * Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 * Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Has adequate hematological function per protocol * Has adequate renal function per protocol * Has adequate hepatic function per protocol * Agrees to use effective contraception while on the study and for 6-months after the end of the study * Provides written informed consent(s) Exclusion Criteria: * Has left ventricular ejection fraction (LVEF) \<50% * Had prior epidermal growth factor receptor (EGFR) targeted regimen * Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy * Had prior chemotherapy for recurrent/metastatic disease * Had anti-cancer therapy between biopsy and submission of sample * Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years * Has known history of brain metastases or active brain metastases * Has uncontrolled hypertension * Has clinically significant electrocardiograph (ECG) findings * Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication * Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment * Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment
References
Publications (2)
- DERIVEDBarber PR, Mustapha R, Flores-Borja F, Alfano G, Ng K, Weitsman G, Dolcetti L, Suwaidan AA, Wong F, Vicencio JM, Galazi M, Opzoomer JW, Arnold JN, Thavaraj S, Kordasti S, Doyle J, Greenberg J, Dillon MT, Harrington KJ, Forster M, Coolen ACC, Ng T. Predicting progression-free survival after systemic therapy in advanced head and neck cancer: Bayesian regression and model development. Elife. 2022 Dec 23;11:e73288. doi: 10.7554/eLife.73288. PMID 36562609
- DERIVEDForster MD, Dillon MT, Kocsis J, Remenar E, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21. PMID 31648099