​Clinical Trials

Ongoing Studies

CHIMES STUDY

“An open-label, multicenter study to assess disease activity and biomarkers of neuronal damage in minority patients with relapsing multiple sclerosis receiving treatment with Ocrelizumab” 

Trial Phase: III

Sponsor: Genentech/Roche

PI: Prof Mansoor Saleh, 

Status: Ongoing

Therapeutic Area: Neurology 

Brief Summary: ​Op​​en-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study


TALIOS STUDY

“A 3-arm, randomized, blinded, active-controlled phase II study of RO7121661, a PD-1/tim-3 bispecific antibody and ro7247669, a pd-1/lLAG-3 bispecific antibody, compared with Nivolumab in participants with advanced or metastatic squamous cell carcinoma of the esophagus”

Trial Phase: II

Sponsor: Genentech/Roche

PI: Prof Mansoor Saleh, 

Status: Recruiting

Therapeutic Area: Oncology

Brief Summary: This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of RO7121661 and RO7247669, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen. Following approval of the protocol amendment version 3, recruitment into the RO7121661 arm has been stopped. The decision to stop recruitment for RO7121661 was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for RO7121661 remains unchanged. The study was planned to enroll participants randomized in a 1:1:1 ratio to receive RO7121661, RO7247669, or nivolumab. With version 3 of the protocol, recruitment into the RO7121661 has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either RO7247669 or nivolumab


LIDERA STUDY

"A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant gdc 9545 compared with physician's choice of adjuvant endocrine monotherapy in patients with estrogen receptor−positive, her2 negativeearly breast cancer"

Trial Phase: III

Sponsor: Genentech/Roche

PI: Prof Mansoor Saleh, 

Status: Recruiting 

Therapeutic Area: Oncology

Brief Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.


SANOFI VAT008 COVID 19 VACCINE STUDY

“A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older”

Trial Phase: III

Sponsor: Sanofi

PI: Prof Mansoor Saleh,

Status: Ongoing

Therapeutic Area: Infectious Diseases

Brief Summary: The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant.


ASTEFANIA STUDY

“A Phase III, randomized, double-blind, placebo-controlled clinical trial of Atezolizumab or placebo in combination with Trastuzumab emtansine as adjuvant therapy for patients with Her2-positive primary breast cancer at high risk of recurrence who have residual tumor present pathologically in the breast and/or axillary lymph nodes following preoperative therapy”

Trial Phase: III

Sponsor: Genentech/Roche

PI: Prof Mansoor Saleh, 

Status: Recruiting

Therapeutic Area: Oncology

Brief Summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.


SKYSCRAPER -7 STUDY

“A phase III, randomized, double-blind, placebo-controlled study of Atezolizumab with or without Tiragolumab (anti-tigit antibody) in patients with unresectable esophageal squamous cell carcinoma whose cancers have not progressed following definitive concurrent chemoradiotherapy”

Trial Phase: III

Sponsor: Genentech/Roche

PI: Prof Mansoor Saleh, 

Status: Recruiting

Therapeutic Area: Oncology

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).​


Completed Studies

EMPACTA STUDY

“A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Tocilizumab in hospitalized patients with COVID-19 pneumonia” 

Trial Phase: III

Sponsor: Genentech/Roche

PI: Dr Reena Shah,

Accrual N = 10 (top accrual in Africa)

Therapeutic Area: Infectious Diseases

Publication: Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia (NEJM)https://pubmed.ncbi.nlm.nih.gov/33332779/ 

Summary: This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia.

            

EMPACTA LTFU STUDY

“Long-Term, Follow-Up Sub-study of Patients with COVID-19 Associated Pneumonia Who Participated in a Genentech/Roche Sponsored Study That Evaluates Patients with COVID-19 Associated Pneumonia”

Trial Phase: III

Sponsor: Genentech/Roche

PI: Dr Reena Shah, 

Therapeutic Area: Infectious Diseases

Summary: This study (EMPACTA LTFU) will a) is an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia


AKU IIT LDRT STUDY

“A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe COVID 19 pneumonia patients on (or requiring) mechanical ventilatory support”

Trial Phase: Ib/II

Sponsor: Aga Khan University (Investigator Initiated Trial –IIT)

PI: Prof Mansoor Saleh

Start date: Dec 4, 2020 

End Date: May 11, 2021

Accrual: n= 10

Therapeutic Area: Infectious Diseases

Publication: A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) for the treatment of severe COVID-19 pneumonia: First experience from Africa

Saleh M, Sharma K, Shah J, Karsan F, Waweru A, Abayo I, et al. (2022) A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) for the treatment of severe COVID-19 pneumonia: First experience from Africa. PLOS ONE 17(7): e0270594. https://doi.org/10.1371/journal.pone.0270594


HEALTHY ROUTE STUDY

“A Non-Interventional Pilot Study to Evaluate A Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate from Digital Retinal Images”

Trial Phase: II

Sponsor: AstraZeneca

PI: Prof Mansoor Saleh, 

Specialty: Ophthalmology/Endocrinology

Brief Summary: This is a non-interventional pilot study with the following objectives: Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments, Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures and to determine the required sample size needed to support a future study to fully validate the machine-learning algorithm


For more information about any of the CRU Studies kindly email cru.info@aku.edu or call +254 020 366 1097