Clinical trials: completed, sponsored by Hoffmann-La Roche
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Facioscapulohumeral Muscular Dystrophy (FSHD)
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult…
- Trial name
- MANOEUVRE (NCT05548556)
- Testing
- RO7204239
- Where
- 9 sites in United States, Denmark and 2 more
- Volunteers
- 51 people
- Sponsor
- Hoffmann-La Roche
Childhood Idiopathic Nephrotic Syndrome
A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25…
- Trial name
- INShore (NCT05627557)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 35 sites in United States, Belgium and 7 more
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Neoplasms
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who…
- Trial name
- NCT03194893
- Testing
- Alectinib, Crizotinib
- Where
- 29 sites in United States, France and 7 more
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Non-Small-Cell Lung
A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based…
- Trial name
- NCT03456063
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Nab-paclitaxel, Pemetrexed
- Where
- 117 sites in United States, Australia and 22 more
- Volunteers
- 453 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in…
- Trial name
- NCT02486718
- Testing
- Atezolizumab, Cisplatin, Vinorelbine
- Where
- 216 sites in United States, Australia and 20 more
- Volunteers
- 1,280 people
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081
This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on…
- Trial name
- NCT06809608
- Testing
- RO7795081, Itraconazole, Gemfibrozil
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e.
- Trial name
- NCT03599245
- Testing
- Ocrelizumab
- Where
- 161 sites in Argentina, Belgium and 24 more
- Volunteers
- 1,055 people
- Sponsor
- Hoffmann-La Roche
Small Cell Lung Carcinoma
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with…
- Trial name
- SKYSCRAPER-02C (NCT04665856)
- Testing
- Tiragolumab, Atezolizumab, Carboplatin
- Where
- 16 sites in China
- Volunteers
- 123 people
- Sponsor
- Hoffmann-La Roche
Esophageal Squamous Cell Carcinoma
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy
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…
- Trial name
- SKYSCRAPER-07 (NCT04543617)
- Testing
- Tiragolumab, Atezolizumab
- Where
- 166 sites in United States, Argentina and 26 more
- Volunteers
- 760 people
- Sponsor
- Hoffmann-La Roche
Macular Degeneration
Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration
This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular…
- Trial name
- BURGUNDY (NCT04567303)
- Testing
- Zifibancimig, Ranibizumab, Port Delivery Platform
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 177 people
- Sponsor
- Hoffmann-La Roche
Endometrial Cancer
A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer
This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.
- Trial name
- EndomERA (NCT05634499)
- Testing
- Giredestrant
- Where
- 11 sites in United States, Canada and 2 more
- Volunteers
- 33 people
- Sponsor
- Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one…
- Trial name
- NCT02546700
- Testing
- Lebrikizumab
- Where
- 63 sites in United States, Argentina and 7 more
- Volunteers
- 309 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction
This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced…
- Trial name
- NCT04661150
- Testing
- Atezolizumab, Trastuzumab, Capecitabine
- Where
- 8 sites in China
- Volunteers
- 42 people
- Sponsor
- Hoffmann-La Roche
Paroxysmal Hemoglobinuria, Nocturnal
Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be…
- Trial name
- COMPOSER (NCT03157635)
- Testing
- Crovalimab
- Where
- 15 sites in France, Germany and 5 more
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors
This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against…
- Conditions
- Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor, Hemophilia A
- Trial name
- HAVEN 6 (NCT04158648)
- Testing
- Emicizumab
- Where
- 22 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Hoffmann-La Roche
Esophageal Cancer
A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma
The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo…
- Trial name
- SKYSCRAPER-08 (NCT04540211)
- Testing
- Atezolizumab, Tiragolumab, Paclitaxel
- Where
- 67 sites in China, Hong Kong and 3 more
- Volunteers
- 461 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult…
- Trial name
- NCT07081958
- Testing
- RO7795081
- Where
- 36 sites in United States
- Volunteers
- 352 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC.
- Trial name
- HORIZON 2 (NCT06624059)
- Testing
- Alectinib, Cisplatin, Carboplatin
- Where
- 11 sites in Australia, Brazil and 4 more
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.
- Trial name
- NCT04158258
- Testing
- Bevacizumab, Trastuzumab, Ado-trastuzumab emtamsine
- Where
- 30 sites in Argentina, Brazil and 8 more
- Volunteers
- 2,907 people
- Sponsor
- Hoffmann-La Roche