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Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer

NCT03539198 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2024-11-14

No results posted yet for this study

Summary

This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.

Conditions

Interventions

RADIATION

Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)

Patients will be receiving proton SBRT

RADIATION

Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients will receive proton SBRT.

DRUG

Nivolumab 3 mg/kg IV q2 weeks

Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.

RADIATION

Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Sponsors & Collaborators

Principal Investigators

  • Daniel J. Ma, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2020-01-06
Completion
2020-01-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539198 on ClinicalTrials.gov