The GW Cancer Center is proud of its physician scientists and their commitment to medical research. These clinical studies are designed to add to the medical knowledge base and relate to the treatment, diagnosis, and prevention of diseases or conditions.

Clinical Program Title Description
Cutaneous Oncology Program 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

Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

 

Urological Oncology Program A Phase I Study of Entinostat in Combination with Enzalutamide for Treatment of Patients with Castration-Resistant Prostate Cancer

A Phase I Study of Entinostat in combination with Enzalutamide for treatment of patients with castration-resistant prostate cancer (CRPC)

Objectives:

  1. Determine the safe dose of Entinostad when given in combination with Enzalutamide in CRPC patients
  2. Determine the safety profiles of the combination of Entinostat and Enzalutamide

Candidates: Patients who have CRPC progressing on ADT and indicated for Enzalutamide as the next line of treatment

Urological Oncology Program Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) versus Observation

To determine DFS and Overall Survival in all patients with muscle-invasive bladder and upper-tract urothelial carcinoma treated with adjuvant MK-3475 (pembrolizumab) vs. observation.

Urological Oncology Program Cabazitaxel with Abiraterone versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

Studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body.

Urological Oncology Program A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival