• GW Cutaneous Oncology Program
  • Comprehensive Skin Cancer and Supportive Oncodermatology Services
  • The GW Cancer Center's Cutaneous Oncology Program is a leading comprehensive melanoma and non-melanoma skin cancer treatment center in Washington, D.C. Every skin cancer is different, and as a result, we take an individualized approach to each skin cancer patient. Our multidisciplinary team includes specialists in medical and surgical dermatology, head and neck surgery, plastic surgery, medical oncology, radiation oncology, dermatopathology, and genetic counseling. Our team works closely together to offer patients the most personalized treatment plan for their skin cancer, no matter how common, rare or complex. Together, your team will develop a treatment plan tailored to your disease, your concerns, and your lifestyle considerations.

Program Information

The GW Cancer Center's Cutaneous Oncology program oversees the care of patients with all types of active skin cancers, as well as patients with suspected skin cancers who are in need of diagnostic testing or surveillance. Skin cancers are more common than all other cancers combined, and the incidence of skin cancers is rising faster than any other type of cancer. The Cutaneous Oncology Program provides highly specialized care for all types of skin cancer.

We also provide care for patients experiencing skin-related side effects from any type of cancer or its treatment through our Supportive Oncodermatology Clinic, including:

  • Skin reactions to cancer chemotherapy
  • Skin reactions to radiation therapy
  • Hair or nail changes due to cancer chemotherapy
  • Graft-versus-host disease (GVHD)

Our personalized and multidisciplinary approach allows patients to have access to a wide variety of physicians during their visit, including:

  • Dermatologists evaluate and monitor suspicious lesions and help to manage the side effects of chemotherapy and radiation therapy
  • Dermatopathologists evaluate tissue slides of possible cancerous lesions
  • Dermatologic surgeons and surgical oncologists work together to most effectively remove malignant lesions using cutting edge surgical therapies like Mohs micrographic surgery
  • Radiation oncologists add radiation therapy to bolster cure rates
  • Medical oncologists add chemo and immunotherapy to treat more advanced skin cancers
  • Genetic counselors help patients understand and manage their risk for cancer

Our program is broken into four specialized weekly multidisciplinary clinics which include:

Program Information

Approach to Treatment

You will be cared for by a comprehensive team that combines leading experts with the latest technological and research advances. Our multidisciplinary team works together to create a personalized treatment plan that supports all of your medical, nutritional and emotional needs. At the GW Cancer Center's Cutaneous Oncology Program, you will have access to:

  • A multidisciplinary treatment team of world-renowned experts in dermatologic oncology, dermatologic and Mohs surgery, dermatopathology, head and neck surgery, reconstructive surgery, radiation oncology, medical oncology and radiology
  • Clinical trials
  • Advanced radiation oncology techniques including external beam radiation therapy (EBRT), intensity modulated radiation therapy (IMRT) and surface mold computer-optimized high-dose-rate bracytherapy (SMBT)
  • Phototherapy
  • Mohs Surgery, including using immunostains for Melanoma, Merkel Cell Carcinoma and other aggresive or rare skin cancers.
Skin Cancer Information for Patients

Skin cancers are more common than all other cancers combined. The incidence of skin cancers is also rising faster than any other cancer. Skin cancers can include:

Research and Clinical Trials

The GW Cancer Center's Cutaneous Oncology Program offers a variety of clinical trials. Patients can also enroll in our blood, tissue and database collection studies for melanoma, squamous cell carcinoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. For more information about enrolling in a clinical trial or collection study, please contact Janene Herring, Cutaneous Oncology Program coordinator at (202) 741-2829 or email skincancer@mfa.gwu.edu.

Mohs Micrographic Surgery (MMS)

Developed in the 1940s by Dr. Frederic Mohs, MMS is an outpatient procedure that involves surgically removing the visible tumor, along with a thin layer of normal-appearing tissue around and beneath the tumor.

Learn more >>

Page last updated: July 2019

Title Description
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II TO IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Primary outcome measures:
Pathologic complete response (pCR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]

Secondary outcome measures:

  1. Major pathologic response (mPR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]
  2. pCR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
  3. mPR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
  4. Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1 [Time Frame: Up to 12 weeks]
  5. Event free survival (EFS) [Time Frame: Up to 50 months]
  6. Disease free survival (DFS) [Time Frame: Up to 47 months]
  7. Overall survival (OS) [Time Frame: Up to 50 months]
  8. Incidence of adverse events (AEs) [Time Frame: Up to 52 months]
  9. Incidence of serious adverse events (SAEs) [Time Frame: Up to 52 months]
  10. Incidence of deaths [Time Frame: Up to 52 months]
  11. Incidence of laboratory abnormalities [Time Frame: Up to 52 months]
  12. Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab [Time Frame: Up to 12 weeks]
  13. Change in post-surgical management plan in the screening period versus actual post-surgical management [Time Frame: Up to 14 weeks]

Key Inclusion Criteria:

  1. Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
  2. At least 1 lesion that is measurable by RECIST 1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria:

  1. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
  2. Distant metastatic disease (M1), visceral and/or distant nodal
  3. Prior radiation therapy for CSCC
  4. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
  5. Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
  6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
  7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
  8. Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

  • To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
  • To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
  • To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT

Key Inclusion Criteria:

  • Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease
  • High risk CSCC, as defined in the protocol
  • Completion of curative intent post-operative radiation therapy (RT) within 2 to 6 weeks of randomization
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
  • Adequate hepatic, renal, and bone marrow function as defined in the protocol

Key Exclusion Criteria:

  • Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
  • Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
  • Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
  • Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary)
  • Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
  • Has had prior systemic anti-cancer immunotherapy for CSCC
  • Note: Other protocol defined Inclusion/Exclusion criteria apply
GW Cutaneous Oncology Program
22nd & I Street, NW 2nd Floor
Washington , DC
United States

Schedule an Appointment

(202) 741-2829 or email skincancer@mfa.gwu.edu