Clinical trials: open to volunteers, sponsored by Hoffmann-La Roche
Hemophilia A
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia…
- Trial name
- NCT05987449
- Testing
- NXT007
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
Metastatic Castration-Resistant Prostate Cancer
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected…
- Trial name
- InavoPC (NCT07287150)
- Testing
- Inavolisib, Enzalutamide, Abiraterone
- Where
- 48 sites in United States, Australia and 10 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Early-stage HER2+ Breast Cancer
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).
- Trial name
- Close2HER (NCT07527741)
- Where
- 10 sites in Serbia
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Obesity, Overweight
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight…
- Conditions
- Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM)
- Trial name
- NCT07670416
- Testing
- Enicepatide
- Where
- 21 sites in China
- Volunteers
- 300 people
- Sponsor
- Hoffmann-La Roche
Progressive Multiple Sclerosis
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)
The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab.
- Trial name
- Mintaka (NCT07282574)
- Testing
- RO7268489, Ocrelizumab
- Where
- 114 sites in Australia, Brazil and 10 more
- Volunteers
- 360 people
- Sponsor
- Hoffmann-La Roche
Alzheimer's Disease
Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
- Trial name
- TARBELA-AD (NCT07781657)
- Testing
- RO7568282
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight, Cardiovascular Disease
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or…
- Trial name
- ZUPREME-5 (NCT07843472)
- Testing
- Petrelintide
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight, Type 2 Diabetes
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or…
- Trial name
- ZUPREME-4 (NCT07843485)
- Testing
- Petrelintide
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Obesity or Overweight
A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or…
- Trial name
- ZUPREME-3 (NCT07843498)
- Testing
- Petrelintide
- Where
- 3 sites in United States
- Volunteers
- 3,900 people
- Sponsor
- Hoffmann-La Roche
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close…
- Trial name
- NCT04802759
- Testing
- Giredestrant, Abemaciclib, Ipatasertib
- Where
- 32 sites in United States, Australia and 3 more
- Volunteers
- 316 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with…
- Trial name
- POSTERITY (NCT05039619)
- Testing
- Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol
- Where
- 44 sites in United States, Brazil and 10 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small…
- Trial name
- NCT05091424
- Testing
- Mosunetuzumab, Tocilizumab, Venetoclax
- Where
- 31 sites in United States, Australia and 8 more
- Volunteers
- 332 people
- Sponsor
- Hoffmann-La Roche
Mature B-Cell Non-Hodgkin Lymphoma
A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma
The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric…
- Trial name
- iMATRIX GLO (NCT05533775)
- Testing
- Obinutuzumab, Glofitamab, Rituximab
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 65 people
- Sponsor
- Hoffmann-La Roche
Multiple Myeloma
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM).
- Trial name
- PLYCOM (NCT05583617)
- Testing
- Cevostamab, Lenalidomide, Tocilizumab
- Where
- 16 sites in Australia, France and 4 more
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic…
- Trial name
- KRAScendo 170 (NCT05789082)
- Testing
- Divarasib, Pembrolizumab, Carboplatin
- Where
- 71 sites in United States, Argentina and 16 more
- Volunteers
- 320 people
- Sponsor
- Hoffmann-La Roche
Lymphoma
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed…
- Trial name
- GLOBRYTE (NCT06084936)
- Testing
- Obinutuzumab, Glofitamab, Rituximab
- Where
- 83 sites in United States, Australia and 11 more
- Volunteers
- 182 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple…
- Trial name
- REMERGE (NCT06274515)
- Testing
- Tumor Tissue and Blood Draw
- Where
- 28 sites in Belgium, Denmark and 6 more
- Volunteers
- 320 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS…
- Trial name
- Krascendo 2 (NCT06793215)
- Testing
- Divarasib, Pembrolizumab, Pemetrexed
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult…
- Trial name
- NCT06862869
- Testing
- Alectinib
- Where
- 44 sites in China
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche