NCT03988647

Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma

A Phase 2 Study of Palliative Radiation Therapy and Anti-PD-1/PD-L1 Checkpoint Blockade in Patients With Metastatic Merkel Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess 1) the safety and 2) efficacy of combining Anti-PD-1/PD-L1 blockade with palliative radiation therapy in patients with Stage IV Merkel Cell Carcinoma.

Detailed description

The hypothesis for this study is that local radiation therapy (RT) can be safely used in combination with PD-1/PD-L1 blockade. This combination therapy may have the potential to enhance the induction of systemic anti-Merkel cell carcinoma immune responses, which will inhibit growth and kill Merkel cell tumor cells in sites of established metastases outside of the local radiation therapy field.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab administered at 200 mg IV every 3 weeks
RADIATION	Radiation Therapy	9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).

Timeline

• Start date: 2019-07-24
• Primary completion: 2020-11-16
• Completion: 2021-01-20
• First posted: 2019-06-17
• Last updated: 2021-08-09
• Results posted: 2021-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study