NCT03982004

Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

Phase IB Pilot Study of Epicutaneous Cryoimmunotherapy Combined With Pembrolizumab for Cutaneous Metastatic Breast Cancer

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

Summary

The purpose of this research study is to look at the safety and side effects of combining the drug pembrolizumab with imiquimod, GM-CSF, and cryotherapy to treat breast cancer that includes skin lesions.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DEVICE	Epicutaneous cryoimmunotherapy	Epicutaneous cryoimmunotherapy (EC) treatment includes liquid nitrogen cryotherapy applied for 10 seconds x 2 freeze-thaw cycles. Four treatment areas will be chosen at each treatment.
DRUG	Topical imiquimod	Patients will apply the cream directly over the treatment areas and can use up to one packet per day (covers approximately 5 cm x 5 cm).
DRUG	Pembrolizumab	Pembrolizumab 200 mg will be administered as a 30 minute IV infusion
OTHER	Dermatologic Quality of Life Index	* 10 questions about how much skin problems has affected the participant's life over the past week * The scoring of each question is as follows: very much = 3, a lot = 2, a little = 1, not at all = 0, not relevant = 0, and question #7 'prevented work or studying' = 3 * The DLQI is calculated by summing the score of each question resulting in a max of 30 and min of 0. The higher the score, the more quality of life is impaired.
OTHER	Functional Assessment of Cancer Therapy	* 5 subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns) * Answers ranging from 0=Not at all to 4 = very much * Each item is rated on a 5-point Likert scale. * The higher the score on the social/family well-being and functional well-being indicate higher quality of life * The lower the score on physical well-being, emotional well-being, and additional concerns indicate higher quality of life
DRUG	Intra-lesional GM-CSF	250 mcg every 2 weeks x 3 doses then every 3 weeks for 3 doses
DEVICE	Cry-AC	-Device used to give the cryoimmunotherapy
PROCEDURE	Cutaneous tumor biopsy	-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.
PROCEDURE	Peripheral blood draw for research	-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-03-03
• Completion: 2021-03-03
• First posted: 2019-06-11
• Last updated: 2021-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study