A Phase II Trial of Pembrolizumab (MK-3475) in Metastatic Cutaneous Squamous Cell Carcinoma

Emory University1 site in 1 country11 target enrollmentJanuary 27, 2017

ConditionsRecurrent Skin Carcinoma Skin Squamous Cell Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Recurrent Skin Carcinoma
Sponsor: Emory University
Enrollment: 11
Locations: 1
Primary Endpoint: Response Rate of Pembrolizumab
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This phase II trial studies how well pembrolizumab works in treating patients with skin cancer that has spread from where it started to nearby tissue, lymph nodes, or other parts of the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Description

PRIMARY OBJECTIVE: -To establish the response rate of pembrolizumab in metastatic cutaneous squamous cell carcinoma. SECONDARY OBJECTIVES: -To determine the 6-month progression-free survival and 1 year overall survival of metastatic cutaneous squamous cell carcinoma of the skin (cSCC) treated with pembrolizumab. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 8-12 weeks.

Registry

clinicaltrials.gov

Start Date

January 27, 2017

End Date

May 18, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Emory University

Responsible Party

Principal Investigator

Michael Lowe

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

•All subjects must have cutaneous squamous cell carcinoma that is not curable by surgery or radiation; both locally advanced and metastatic squamous cell carcinoma will be included.
•Be willing and able to provide written informed consent/assent for the trial.
•Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
•Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day
•Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor.
•Be willing to undergo normal skin biopsy prior to initiation of treatment and after treatment.
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
•Absolute neutrophil count (ANC) ≥ 1,500/microliter (mcL)
•Platelets ≥ 100,000/mcL
•Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, patients with human immunodeficiency virus (HIV) adequately controlled on antiretrovirals (undetectable viral load) and patients with chronic lymphocytic leukemia (CLL) not requiring systemic treatment will be included; in addition, steroids for physiologic replacement will be allowed (must be equal to or less than 10mg of prednisone/day).
•Has a known history of active TB (bacillus tuberculosis).
•Hypersensitivity to pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Asymptomatic CLL, not requiring intervention will be included as long as patients meet routine laboratory parameters of the study as outlined above. In addition, patients who have undergone curative bone marrow transplant and currently not requiring immunosuppression, will be allowed on study.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

Outcomes

Primary Outcomes

Response Rate of Pembrolizumab

Time Frame: Up to 1 year after treatment discontinuation (max treatment duration of 3 years)

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Secondary Outcomes

Overall Survival(Up to 1 year after treatment discontinuation (max treatment duration of 3 years))
Progression-free Survival(Up to 6 months after treatment discontinuation (max treatment duration of 3 years))