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:

  1. What is the purpose of the clinical trial?
  2. Does the study involve a new, existing or placebo treatment?
  3. What is expected of me as a participant?
  4. Will my identity be confidential for the duration of the trial?
  5. How often will the treament be given?
  6. How will the treatment be given?
  7. Do I or my medical aid have to pay for anything?
  8. Will I be reimbursed for travel costs?
  9. If I am responding well to the treament, can I keep using it after the study?
  10. 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.

Colorectal Cancer

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).

Solid Tumors

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

Urothelial Cancer

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