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Pembrolizumab for Basal Cell Carcinoma

Phase 1

Waitlist Available

Led By Brian Gastman, MD

Research Sponsored by Brian Gastman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Histological confirmation of diagnosis of Basal cell carcinoma of any subtype

Must not have

History of allogeneic tissue/solid organ transplant

Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial will test the use of anti-PD-1 neoadjuvant therapy, given prior to surgery, in order to provide a better outcome for patients with basal cell carcinoma. The study team will also gather information about recurrence rates.

Who is the study for?

This trial is for adults with advanced basal cell carcinoma of the head and neck, large enough to require surgery and possibly post-operative radiation. Participants must not be pregnant or planning pregnancy, have confirmed diagnosis, adequate organ function without severe immunosuppression, no recent cancer other than certain skin cancers or low-grade tumors, and no history of life-threatening virus infections.

What is being tested?

The study tests Pembrolizumab as a neoadjuvant (before surgery) therapy in patients with basal cell carcinoma. It aims to see if this treatment can improve outcomes before surgery and potentially eliminate the need for surgery altogether. Pembrolizumab is an experimental drug designed to boost the immune system's response against cancer cells by blocking PD-1 protein receptors.

What are the potential side effects?

Pembrolizumab may cause side effects such as fatigue, skin reactions, inflammation in various organs like lungs (pneumonitis), liver problems, hormonal gland issues (like thyroid dysfunction), infusion-related reactions, and changes in blood counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My skin cancer is confirmed as basal cell carcinoma.

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My basal cell carcinoma is at a high risk of coming back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ or tissue transplant from another person.

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I have a history of HIV or Hepatitis B/C.

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I have an immune system disorder or I'm on long-term steroids.

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I have an active tuberculosis infection.

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I have been treated with Hedgehog inhibitors before.

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I have been treated with cancer-fighting drugs before.

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I have active brain metastases or cancer in the lining of my brain.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic response as assessed by change in tumor volume (RECIST 1.1)

Secondary outcome measures

Number of changes to surgical field which could negatively influence resection

Number of participants experiencing a grade 3 or higher Adverse Event

One-year recurrence rates after completion of neoadjuvant-adjuvant therapy

+2 more

Other outcome measures

Number of Tumor Infiltrating Lymphocytes (TILs)

Percent of key peripheral blood lymphocytes (PBLs) in pCRs vs partial responders (pPR) vs non responders

Phenotypes of the TILs and PBMCs prior and post treatment

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: PermbrolizumabExperimental Treatment2 Interventions

Participants will undergo fine cut CT imaging (head and neck) followed by at least 4 doses of pembrolizumab q 3 weeks. After the 4th dose of pembrolizumab as appropriate, patients will undergo standard surgical resection, with all non-marginal tissue as well as the pre-op biopsy to be stored for collateral research. 2 weeks after initial flap or graft insert (which would be equivalent to stage 1 of a forehead flap) patients would continue for a total of approximately 1 year of pembrolizumab q 3 weeks (another 13 doses, thus 17 doses total).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brian GastmanLead Sponsor

Brian Gastman, MD2.69 ReviewsPrincipal Investigator - Cleveland Clinic, Case Comprehensive Cancer Center

Case Comprehensive Cancer Center

3 Previous Clinical Trials

339 Total Patients Enrolled

5Patient Review

Dr.Gastman did an excellent job on my parotidectomy and even called me at home post-surgery to check in. The stitches were barely noticeable and I healed up quickly. I would definitely recommend him to others!