Upstream
Name: A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck "UPSTREAM"
Acronym: Upstream
Summary & Eligibility:
This study is for patients with head and neck cancer which has spread (metastatic) or the tumour has come back after previous treatment (recurrent). We are looking at an approach called ‘personalised medicine’ which looks at the unique way the tumour is made up, and finding the best treatment for it.
Different people have different genes or proteins, also called ‘biomarkers’ that make up their tumour. Treatment can be tailored to that person according to their biomarkers with the hope that the outcome will be better than the standard treatment.
Currently, the treatment options for head and neck cancer are based on tumour location and severity and not by looking at people’s biomarkers. This is because the use of biomarkers in this type of complex cancer is not yet fully understood. Research studies such as this one are needed to understand these unique biomarkers and help researchers and drugs companies improve treatments.
Usually people with recurrent or metastatic head and neck cancer are treated with different types and combinations of chemotherapy, targeted therapy and more recently, immune therapy.
The main aim of this study is to assess how effective and safe, targeted drugs or immune therapy are compared to standard treatments for people with recurrent and metastatic head and neck cancer. Patients will receive treatment (immune therapy or target therapy) based on the specific biomarkers that we find in their tumour at a central testing laboratory.
General inclusion Criteria:
- Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx not amenable to curative treatment.
- At least one measurable lesion by MRI or CT-scan
- Progressive disease after first line platinum-based chemotherapy or progressive disease within 1 year if platinum-based chemotherapy was given as a part of the multimodal curative treatment.
- Tumour core biopsy from any accessible tumour site available for central testing.
- Patients must have adequate organ function
- Clinically normal cardiac function
- Patients ≥ 18 years old and must be able to give written informed consent.
- Women of child-bearing potential must have a negative pregnancy test
- Patients of childbearing / reproductive potential must agree to use highly effective methods of contraception to 6 months after the last treatment dose
- Female subjects who are breast feeding should agree to discontinue nursing prior to the first dose of study treatment and up to 6 months after the last study treatment.
General exclusion criteria:
- Unresolved and significant toxicity from previous anticancer therapy
- History of cardiovascular conditions within 6 months prior to registration
- Nasopharynx and sino-nasal tumor
- Surgery, investigational drugs, chemotherapy or other anticancer therapy within 4 weeks before registration. Curative radiation therapy within 8 weeks of registration.
- Any malignancy within the last 3 years prior to registration
- Known untreated and uncontrolled brain metastases or carcinomatous meningitis
- Known diagnosis of immune deficiency or a known history of HIV
- Known active Hepatitis B, Hepatitis C or pre-existing liver cirrhosis
- Other uncontrolled active illnesses
Please contact the study coordinator for full list of inclusion and exclusion criteria as this differs between allocated cohorts
Status: Open
Sponsor: EORTC – European Organisation for Research and Treatment for Cancer
Study Coordinator:
Jean-Pascal Machiels
Cliniques Universitaires St. Luc
Avenue Hippocrate, 10
BE 1200 Brussels
Belgium
E-mail: jean-pascal.machiels@uclouvain.be
Study Schema:
