Back to search results

Preoperative Immunotherapy for Head and Neck Cancer

This study is looking at how well certain immunotherapy drugs work before surgery for squamous cell carcinoma of the head and neck (SCCHN). Researchers are testing atezolizumab alone, or in combination with tiragolumab or tocilizumab. These drugs aim to boost your body's immune system to fight cancer. The main goals are to see if these treatments increase certain immune cells (CD3 counts) in the tumor and improve surgical success (R0 resection rate). You may be able to join if you are 18 or older, have SCCHN that can be surgically removed, and are willing to provide a pre-treatment biopsy. The study plans to enroll 55 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 55 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to measure the study's main outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03708224

Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Alain Algazi
~55 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:AtezolizumabTocilizumabTiragolumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects with a >= 40% increase in the cluster of differentiation 3 (CD3) counts
Measured over Up to 12 months
+1 more outcome measured

Conditions

Cancer
Carcinoma
Squamous Cell Carcinoma
Head and Neck Cancer

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alain Algazi, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) \>=1,500 /microliter (mcL)
Platelets \>=100,000 / mcL
Hemoglobin \>= 9 g/dL
Lymphocyte count \>= 500/mcL
White blood count \>=3,000/mcL or \<=14,000/mcL
Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR ≥50 mL/min creatinine clearance by Cockcroft-Gault formula for participants in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function. \* Creatinine clearance should be calculated per institutional standard
Serum total bilirubin =\< 1.5 x ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN

Exclusion

Aspartate aminotransferase (AST) \[serum glutamic-oxaloacetic transaminase (SGOT)\] and alanine aminotransferase (ALT) \[serum glutamate pyruvate transaminase (SGPT)\] =\< 3 x ULN
Albumin \>= 2.5 mg/dL
International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin rime (aPTT) =\< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required 8. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 5 months after the last dose of study medication. 9. Male subjects must agree to use an adequate method of contraception and refrain from donating sperm, starting with the first dose of study therapy through 5 months after the last dose of study therapy
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

What this trial measures

  • Proportion of subjects with a >= 40% increase in the cluster of differentiation 3 (CD3) countsUp to 12 months

    Intratumoral CD3+ T-cells will be identified by immunohistochemistry in pre- and post-treatment tumor specimens. The analysis population for the primary outcome will be all patients who received at least 2 weeks of neoadjuvant therapy with pre- and post-treatment tumor specimens that are evaluable for CD3+ T-cells. The proportion of patients with a \>= 40% increase (from pre- to post-treatment) will be calculated. The exact 95% confidence intervals (CIs) using the Pearson-Clopper method and an exact binomial test will be used as an exploratory purpose. The change from pre-treatment to post-treatment CD3 count per mm\^3 as a continuous measure will also be summarized.

  • R0 resection rateUp to 12 months

    Participants who undergo surgery will be evaluable for R0 resection rate. R0 resection rate will be described by point estimate and 95% CI using the Pearson-Clopper method.