NCT02690948

Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer

A Phase 1b Open Label Study of Pembrolizumab for Unresectable or Metastatic Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Anne Chang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1-2 trial studies how well pembrolizumab with or without vismodegib works in treating patients with skin basal cell cancer that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, are checkpoint inhibitors that stimulate immune response. Vismodegib may stop the growth of tumor cells by blocking signals needed for cell growth.

Detailed description

This study is a non-randomized evaluation of pembrolizumab as a treatment for unresectable or metastatic basal cell carcinoma (BCC). Participants are assigned to treatment with pembrolizumab plus vismodegib or pembrolizumab monotherapy on the basis of suitability for treatment with smoothened (SMO) inhibitors such as vismodegib. Prospective participants who have progressed on vismodegib, are intolerant to or have a medical contra-indication to vismodegib may receive pembrolizumab monotherapy. Because treatment is non-randomized, no comparison between treatment groups is conducted. PRIMARY OBJECTIVE To assess the overall response rate (ORR) of unresectable or metastatic BCC patients to pembrolizumab with or without vismodegib (all evaluable patients) at 18 weeks SECONDARY OBJECTIVES * To assess the ORR of unresectable or metastatic BCC patients to pembrolizumab monotherapy at 18 weeks * To assess the ORR of unresectable or metastatic BCC patients to pembrolizumab monotherapy at 9 weeks * To assess ORR of unresectable or metastatic BCC patients to pembrolizumab plus vismodegib at 18 weeks * To assess ORR of unresectable or metastatic BCC patients to pembrolizumab plus vismodegib at 9 weeks * To assess the safety and tolerability of pembrolizumab (either monotherapy or combination therapy) for unresectable or metastatic BCC. * To assess the duration of response after pembrolizumab (either monotherapy or combination therapy) * Incidence and severity of adverse events * Correlative studies including programmed death-ligand 1 (PD-L1) expression pre-treatment, lymphocytic infiltrates pre- and post-treatment, mutational analysis pre- and post-treatment

Conditions

• Skin Basal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Vismodegib	Given PO

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-30
• Completion: 2018-08-29
• First posted: 2016-02-24
• Last updated: 2019-03-08
• Results posted: 2019-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study