Open Trials

At Shenandoah Oncology, research is an integral part of our comprehensive efforts to provide cancer patients in our community with access to the latest and most advanced therapies and treatment options.  As a member of US Oncology Research and as a clinical research affiliate of VCU Massey Cancer Center, we are pleased to share this list of clinical trials currently enrolling at our practice.
 

BREAST CANCER – ADJUVANT

NSABP B-53 / S1207

Phase 3 study comparing standard adjuvant endocrine therapy to the combination of standard endocrine therapy plus everolimus in patients with high-risk hormone receptor positive and HER2 negative breast cancer.  Studies show that the addition of everolimus to standard endocrine therapy can delay disease progression in metastatic disease, and the goal of this study is to establish if the combination of everolimus and standard endocrine therapy will increase the cure rate in the adjuvant setting.

NRG-BR003

Phase 3 study of adjuvant therapy comparing doxorubicin and cyclophosphamide followed by weekly paclitaxel with or without carboplatin for node-positive or high-risk node-negative triple negative invasive breast cancer.

NRG-BROO6

Phase 3 randomized study of Pembrolizumab versus observation in patient with triple negative breast cancer who have ≥1cm residual disease or positive lymph nodes after neoadjuvant chemotherapy

USOR 17-082

Phase 3, open-label study of Abemaciclib combined with standard adjuvant endocrine therapy versus standard endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, HER-2 negative patients. Abemaciclib is a CDK4 and CDK6 inhibitor that was approved by the FDA in September 2017 for use in certain breast cancers.

BREAST CANCER – RECURRENT/ADVANCED

USOR 16-195

Phase 2 study of Tucatinib versus placebo with Caepcitabine and Trastuzumab in patients with advanced or metastatic HER-2 negative breast cancer

CHRONIC LYMPHOCYTIC LYMPHOMA

USOR 15-005

InformCLL:  A disease registry for patients with chronic lymphocytic leukemia.  The study will track current treatment patterns among CLL patients and explore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.

LUNG CANCER, NON SMALL CELL

USOR 17-199

Open-label phase 2 study of Pembrolizumab and AM0010 versus Pembrolizumab alone as first time treatment for patients with metastatic NSCLC and high PD-L1 expression of ≥50%

LYMPHOMA

USOR 17-050

Phase 2 double-blind trial comparing Polatuzamab vedotin with Rituximab and CHP versus Rituximab and CHOP in previously untreated patients with diffuse large B-cell Lymphoma.

MULTIPLE MYELOMA

NONE AT PRESENT

OVARIAN

USOR 16-233

Phase 3 randomized study of Atezolizumab versus placebo administered in combination with Paclitaxel, Carboplatin, and Bevacizumab to patients with newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.

PROSTATE

NONE AT PRESENT

RENAL CELL

USOR 17-103

Phase 3 open-label study to study the efficacy and safety of Pembrolizumab plus Epacadostat versus standard of care (Sunitinib or Pazopanib) as first-line treatment for locally advanced or metastatic renal cell carcinoma. Epacadostat is an IDO1 inhibitor. 

WEIGHT LOSS

BWEL

Randomized phase 3 study evaluating the role of weight loss in adjuvant treatment of overweight or obese women with early HER-2 negative breast cancer.