Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Summary
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.
Timeline
- Start
- 2015-12-22
- Primary completion
- 2018-01-11
- Completion
- 2018-02-21
Outcome
Missed primary endpoint
Stopped: “Trial was terminated by sponsor due to lack of efficacy.”
paper ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6-1.7]; P = 0.96) PMID 31648099 ↗
paper HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5-1.8]; P = 0.82). PMID 31648099 ↗
paper Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum. PMID 31648099 ↗
Publications
- Barber 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.
- Forster 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Patritumab | Monoclonal antibody | 9 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |