Clinical trials: sponsored by Hoffmann-La Roche
Age-Related Macular Degeneration
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells.
- Trial name
- NCT02286089
- Testing
- OpRegen
- Where
- 7 sites in United States, Israel
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Lupus Nephritis
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus…
- Trial name
- REGENCY (NCT04221477)
- Testing
- Obinutuzumab, MMF, Prednisone
- Where
- 74 sites in United States, Argentina and 13 more
- Volunteers
- 271 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting.
- Trial name
- NCT03456076
- Testing
- Alectnib, Cisplatin, Vinorelbine
- Where
- 114 sites in United States, Australia and 25 more
- Volunteers
- 257 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
Muscular Atrophy, Spinal
A Study of Risdiplam in Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
A global study of oral risdiplam in pre-symptomatic participants with spinal muscular atrophy (SMA).
- Trial name
- Rainbowfish (NCT03779334)
- Testing
- Risdiplam
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Severe Hemophilia A
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors
This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A…
- Trial name
- HAVEN 7 (NCT04431726)
- Testing
- Emicizumab
- Where
- 32 sites in United States, Australia and 12 more
- Volunteers
- 55 people
- Sponsor
- Hoffmann-La Roche
Atypical Hemolytic Uremic Syndrome
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
- Trial name
- COMMUTE-p (NCT04958265)
- Testing
- Crovalimab
- Where
- 20 sites in United States, Belgium and 8 more
- Volunteers
- 41 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
Lymphoma
A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma
This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone…
- Trial name
- NCT04980222
- Testing
- Glofitamab, Tocilizumab, Doxorubicin
- Where
- 20 sites in United States, Denmark and 4 more
- Volunteers
- 46 people
- Sponsor
- Hoffmann-La Roche
Relapsed or Refractory Multiple Myeloma
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in…
- Trial name
- NCT06055075
- Testing
- Forimtamig, Carfilzomib, Daratumumab
- Where
- 8 sites in Australia, Canada and 4 more
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS…
- Trial name
- MUSETTE (NCT04544436)
- Testing
- Ocrelizumab, Antihistamine, Methylprednisolone
- Where
- 120 sites in United States, Argentina and 19 more
- Volunteers
- 864 people
- Sponsor
- Hoffmann-La Roche
Muscle-invasive Bladder Cancer
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are…
- Trial name
- IMvigor011 (NCT04660344)
- Testing
- Atezolizumab, Signatera
- Where
- 141 sites in United States, Argentina and 21 more
- Volunteers
- 761 people
- 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
Relapsing Multiple Sclerosis
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated.
- Trial name
- FENopta (NCT05119569)
- Testing
- Fenebrutinib
- Where
- 17 sites in United States, Bosnia and Herzegovina and 4 more
- Volunteers
- 109 people
- Sponsor
- Hoffmann-La Roche
Non Small Cell Lung Cancer
Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer.
- Trial name
- TARSEQ (NCT01350817)
- Testing
- Erlotinib + docetaxel, Docetaxel
- Where
- 30 sites in France
- Volunteers
- 156 people
- Sponsor
- University Hospital, Limoges
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
Carcinoma, Hepatocellular
A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC.
- Trial name
- NCT05908786
- Testing
- Atezolizumab, Bevacizumab, Tiragolumab
- Where
- 14 sites in United States, Austria and 4 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche