NCT03546582

SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma

KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA®) Plus Stereotactic Re-irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).

Detailed description

Safety Run-In: To evaluate the safety of the addition of pembrolizumab (anti PD-1 immunotherapy) to re-irradiation with SBRT for patients with recurrent or new second primary head and neck squamous cell carcinoma (HNSCC). Phase II: To compare progression-free survival (PFS) for patients with recurrent or new second primary head and neck squamous cell carcinoma with SBRT re-irradiation with or without pembrolizumab. OUTLINE: Safety Run-In: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years. Phase II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years. ARM II: Patients receive SBRT over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years. After the completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Anti-PD-1 targeted immunotherapy
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	High-precision radiotherapy

Timeline

• Start date: 2018-11-14
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2018-06-06
• Last updated: 2026-01-20

Locations

18 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study