Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cel… (NCT05110781) | Clinical Trial Compass
TerminatedPhase 2
Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site
Stopped: Slow accrual
United States1 participantsStarted 2021-12-07
Plain-language summary
This phase II trial tests whether atezolizumab works to shrink tumors before surgery in patients with head and neck squamous cell cancer with an unknown or historic primary site that has spread to other places in the lymph nodes (regionally metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab before surgery may reduce the size of the tumor.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with biopsy proven, surgically resectable head and neck cutaneous squamous cell carcinoma regionally metastatic to lymph nodes in the head and/or neck with a historical or unknown (but not concurrent) primary site
* Patients must be \>= 18 years
* Patients with resectable regionally metastatic HNCSCC from an unknown or historical primary and no evidence of distant metastatic disease
* Full decision-making capacity and consent provided and documented
* Radiographically measurable disease per immune Response Evaluation Criteria in Solid Tumors (iRECIST)
* Surgically resectable disease per standard of care (SoC)
* For Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below: \* Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab \* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements \* Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male…
What they're measuring
1
Pathologic Complete Response (pCR)
Timeframe: At time of surgery (up to 10 weeks from time of enrollment)