Clinical trials: sponsored by Hoffmann-La Roche
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance (NCT04586010)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 158 sites in United States, Argentina and 21 more
- Volunteers
- 746 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
Relapsing Multiple Sclerosis
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance 2 (NCT04586023)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 106 sites in United States, Austria and 15 more
- Volunteers
- 751 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, Primary Progressive
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS).
- Trial name
- FENtrepid (NCT04544449)
- Testing
- Fenebrutinib, Ocrelizumab
- Where
- 190 sites in United States, Argentina and 26 more
- Volunteers
- 985 people
- Sponsor
- Hoffmann-La Roche
Crohns Disease
Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's…
- Trial name
- TAHOE (NCT05910528)
- Testing
- Afimkibart
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic…
- Trial name
- Krascendo 1 (NCT06497556)
- Testing
- Divarasib, Sotorasib, Adagrasib
- Where
- 151 sites in United States, Argentina and 24 more
- Volunteers
- 338 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
Alzheimers Disease
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to…
- Trial name
- NCT04639050
- Testing
- RO7126209
- Where
- 37 sites in United States, Australia and 7 more
- Volunteers
- 241 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
Multiple Sclerosis
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
This 12-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT04075266
- Testing
- Ocrelizumab
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 23 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3), and…
- Trial name
- NCT05704361
- Testing
- RO7121932 IV, RO7121932 SC
- Where
- 26 sites in United States, Belgium and 10 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active…
- Trial name
- Ametrine-1 (NCT06589986)
- Testing
- Afimkibart
- Where
- 184 sites in United States, Argentina and 28 more
- Volunteers
- 400 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
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 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
Follicular Lymphoma
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma
This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL).
- Trial name
- NCT04246086
- Testing
- Mosunetuzumab (IV), Tocilizumab, Lenalidomide
- Where
- 26 sites in United States, China and 3 more
- Volunteers
- 237 people
- Sponsor
- Hoffmann-La Roche
Parkinson's Disease
A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease
This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease…
- Trial name
- PASADENA (NCT03100149)
- Testing
- RO7046015
- Where
- 55 sites in United States, Austria and 3 more
- Volunteers
- 316 people
- Sponsor
- Hoffmann-La Roche
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
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