Clinical Trials
The GW Medical Faculty Associates 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.
Phase 1 Study of Intratumoral Administration of VAX014 in Subjects With Advanced Solid Tumors
Primary Outcome Measure:
• Progression-Free Survival (PFS)
o Time Frame: Up to 6 years 6 months
Primary Outcome Measure:
• To assess the safety and tolerability of tucatinib in combination with eribulin and trastuzumab in patients with unresectable or recurrent metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, and trastuzumab deruxtecan.
• Evaluate the relative toxicity/tolerability of these therapeutic agents when used in combination in this…
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
This is a Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combinations In Patients With Metastatic Breast Cancer.
Primary Outcome Measures:
Determination of Overall survival (OS) [Time Frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months]
Determination of the Optimal Biological Dose (OBD) [Time Frame: Up to 15 months]
Frequency of adverse events (AEs) [Time Frame: Up to 15 months]
Severity of adverse events (AEs) [Time Frame: Up to 15…
Primary Outcome Measures:
Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. [Time Frame: Approximately 2 years]
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
Phase 2: Percentage of patients with cystoscopic CR at 48 weeks, based on…
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of…
This phase IIa trial investigates the biomarker (plasma levels of PSA) of low-dose apalutamide in patients with prostate cancer confined in the prostate gland before surgery. Testosterone can cause the growth of prostate cancer cells, and Apalutamide blocks the use of testosterone by the tumor cells. Giving low-dose apalutamide before prostate surgery may lead to lowered PSA levels in men with…
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach…
This is a randomized, parallel, open label Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
This phase II trial tests whether broccoli seed and sprout extract works to break down cancer causing substances of tobacco in heavy smokers. Smokers are at increased risk for developing lung, head and neck, and other cancers. Broccoli seed and sprout extract may help break down and remove toxic substances caused by tobacco use and possibly produce substances that may protect cells from…
This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy…