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:
• 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 a Phase 1/2 single-blind study to evaluate the safety, tolerability, and immunogenicity of licensed BNT162b2 (Omi XBB.1.5) and RIV administered together as a single injection (referred to as BNT162b2 [Omi XBB.1.5]/RIV) in healthy adults 50 years of age or older.

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.

We are trying to learn more about if the gut microbiome (the microbes that live in our digestive tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle changes.

An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious.

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…

This is a phase 3 open label, multi-center, randomized, active-controlled non-inferiority trial that compares the safety and effectiveness of a 6-week regimen of daily rifapentine against the current standard of 12-16 weeks of rifamycin-based treatment for latent TB infection (LTBI).

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…