Sandton Oncology

Active Clinical Trials

I3Y-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.

Clinical Indication:

Postmenopausal subjects who have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease.

 

I3Y-MC-JPCF

A Randomized, Open-Label, Phase 3 Study of Abemaciclib combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer.

Clinical Indication:

This trial is specifically for patients with node positive, early stage, resected hormone receptor positive, HER 2 negative breast cancer who have completed definitive locoregional therapy (with or without neoadjuvant or adjuvant chemotherapy) and are at high risk of disease recurrence.

MK3475-158

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158).

Clinical Indication:

Multiple advanced (metastatic or unresectable) solid tumors which is MSI-H. Subjects must have progressed on or be intolerant to therapies that are known to provide clinical benefit.

  Only two cohorts are still open:

  • (F) Vulvar Squamous Cell Carcinoma,
  • (K) Any advanced solid tumor (except CRC), which is MSI-H. Various subsets exist under this cohort kindly contact site to check.

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.

Clinical Indication:

First line treatment for locally advanced or metastatic urothelial carcinoma.

MK3475 – 598

A Phase 3, Randomized, Double-blind Study of Pembrolizumab plus Ipilimumab vs Pembrolizumab plus Placebo in Previously Untreated, Stage IV, Metastatic Non-Small Cell Lung Cancer subjects whose tumors are PD-L1 Positive (TPS ≥ 50%).

Clinical indication:

First-line treatment of Stage IV metastatic programmed cell death-ligand 1 (PD-L1) positive (TPS ≥ 50%) non-small cell lung cancer (NSCLC).

Archived Clinical Trials

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.

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.

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)

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.

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