Sandton Oncology Centre – Research Group
What are clinical trials?
- A research study on new or existing treatments, involving human volunteers.
- Every clinical trial will be conducted according to a protocol, which must be approved by an Ethics Committee and Medicines Control Council.
- Patients need to give written consent to participate in a clinical trial.
Why are clinical trials conducted?
- To see if a new drug is safe and effective to use.
- To compare existing treatments to see which is better.
Possible benefits of participation?
- Access to new research treatments.
- Contibuting to medical research.
Possible risks of participation?
- Side effects of treatments
- Treatment may not be effective
- Participation in a clincial trial can be time consuming
Ten questions to ask before participating in a Clinical Trial:
- What is the purpose of the clinical trial?
- Does the study involve a new, existing or placebo treatment?
- What is expected of me as a participant?
- Will my identity be confidential for the duration of the trial?
- How often will the treament be given?
- How will the treatment be given?
- Do I or my medical aid have to pay for anything?
- Will I be reimbursed for travel costs?
- If I am responding well to the treament, can I keep using it after the study?
- At the study end, will there be follow up care?
Active clinical trials conducted at our site
Breast Cancer - Metastatic
M12-914 - A Phase III Randomized Placebo-Controlled trial of Carboplatin and Paclitaxel with or without the PARP inhibitor Veliparib (ABT-888) in metastatic or locally advanced unresectable BRCA-associated Breast Cancer.
13Y-CR-JPBQ - A Randomized, Double-blind, placebo-controlled, Phase 3 study to compare NSAI (Anastrozole or Letrozole ) plus Abemaciclib, a CDK4 and CDK6 inhibitor, or plus placebo, and to compare Fulvestrant plus Abemaciclib or plus placebo in postmenopausal women with hormone receptor-positive, HER2-negative locoregionally recurrent or metastatic Breast cancer.
Ovarian - Metastatic
ET743-OVC-3006 - A Randomized, open-label study comparing the combination of YONDELIS® and DOXIL® / CAELYX® monotherapy for treatment of advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Small Cell Lung Cancer - Advanced
CA209-451 - A Randomized, Multicenter, Double-blind, Phase 3 study of Nivolumab, Nivolumab in combination with Ipilimumab, or placebo as maintenance therapy in subjects with extensive- stage disease small cell lung cancer (ED-SCLC) after completion of platinum-based first line chemotherapy.
MK3475-177 - A Phase III study of Pembrolizumab (MK 3475) vs Chemotherapy in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
Head and Neck Cancer
CA209-714 - A Double-blind, Randomized, Two Arm Phase 2 Study of Nivolumab in combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in recurrent or metastatic Squamous cell carcinoma of the Head and Neck (SCCHN).
MK3475-158 - A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158).
Only two cohorts are still open:
- (F) Vulvar Squamous Cell Carcinoma
- (K) Any advanced solid tumor (except CRC), which is MSI-H – confirmed locally
WO30070 - A Phase III, multicenter, randomized, placebo-controlled study of Atezolizumab (anti-PD-L1 antibody) as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma.
Updated: 6 March 2017