Trial Search Results

Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The purpose of the study is to determine whether investigators successfully collect blood and tissue samples in cancer patients receiving immunotherapy with a drug that blocks either PD-1 or PD-L1 (checkpoint inhibitor). Investigators will look for changes in the cancer cells pre and post immunotherapy. In an imaging sub-study, some participants will have a PET/CT scan with an investigational tracer, [18F]F-AraG, to examine if the tracer is a safe and effective way to visualize sites of immune system activation in cancer patients. Results of the main study could inform new treatment regimens, better predict who will respond to therapy, or identify new targets for drug development. Results of the imaging sub-study may help develop new non-invasive ways to monitor drug efficacy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

CellSight Technologies, Inc.

Collaborator: Stanford University

Intervention(s):

  • Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
  • Drug: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Unresectable or metastatic SCCHN.

   - Localized SCCHN.

   - >18 years old.

   - Willing and able to sign consent form.

   - Have standard of care biopsy or resection planned or tumors amenable to serial
   biopsies.

   - For patients with reproductive potential must undergo counseling to understand unknown
   risks to resultant progeny.

Exclusion Criteria:

   - Diagnosis of immunodeficiency or active autoimmune condition.

   - Active tuberculosis

   - Prior exposure to PD-1 or PD-LI treatment

   - Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment.

   - Received a live vaccine within 30 days of planned PD-1 start date.

   - Pregnant or breastfeeding.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Savanna Biedermann
650-721-4079
Not Recruiting