Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

Clinical trial: Biomarker-based Study in R/M SCCHN

Summary: This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.


Eligibility: 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 according to RECIST 1.1, evaluated within 3 weeks prior to treatment allocation. Such lesion must not have been previously irradiated; if the measurable lesion(s) have been irradiated, clear progression must be documented.
  -  Progressive disease after first line platinum-based chemotherapy with or without cetuximab given as palliative treatment or progressive disease within 1 year if platinum-based chemotherapy was given as a part of the multimodal curative treatment.
  -  ECOG performance status 0 -1.
  -  Tumor core biopsy from any accessible tumor site available for central testing.
  -  Patients must have adequate organ function, evaluated within 14 days prior to treatment allocation.
  -  Patients ≥ 18 years old and must be able to give written informed consent.
  -  Patients ≥ 70 years old must undergo the G8 screening.
  -  Women of child-bearing potential must have a negative pregnancy test (serum or urine within the 72 hours prior to cohort allocation).
  -  Sexually active patients must use highly effective methods of contraception as of registration and up to 6 months after the last treatment dose.
  -  Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and up to 6 months after the last study treatment.
  -  Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
  General Exclusion Criteria:
  -  Unresolved and significant toxicity CTCAE version 4.03 grade ≥ 2 from previous anticancer therapy other than alopecia.
  -  Any of the following within 6 months prior to treatment allocation: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of CTCAE version 4.03 Grade 2 or more, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure or ejection fraction of less than 50%, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism. Significant active cardiac disease including uncontrolled high blood pressure according to the CTCAE version 4.03 grade 3.
  -  Nasopharynx and sino-nasal tumor.
  -  Surgery or investigational drugs or chemotherapy or other anticancer therapy within 4 weeks before treatment allocation. Curative radiation therapy (60-70 Gy) within 8 weeks of treatment allocation. Palliative radiation therapy (e.g. 8 Gy on a painful lesion) will be allowed.
  -  Known untreated and uncontrolled brain metastases or carcinomatous meningitis.
  -  Known diagnosis of immune deficiency or a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) or pre-existing liver cirrhosis.
  -  Known pre-existing interstitial lung disease (ILD). Bronchoemphysema should not be considered as ILD.
  -  Other uncontrolled active illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes, …).
  -  Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  -  Any malignancy (other than SCCHN, non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer or basal cell carcinoma of the skin and carcinoma in situ of the cervix or bladder) within the last 3 years prior to treatment allocation.

Relevance to patient case: not relevant