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Atezolizumab for Kidney Cancer (IMmotion010 Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

IMmotion010 Trial Summary

This trial will test whether the experimental drug atezolizumab is better than placebo at preventing disease recurrence in people who have had a kidney removed due to renal cell carcinoma.

Eligible Conditions

Kidney Cancer

IMmotion010 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Investigator-assessed Disease-Free Survival (DFS)

Secondary outcome measures

Disease-Specific Survival

Distant Metastasis-Free Survival

IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3

+10 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Peripheral sensory neuropathy

Pain in extremity

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

IMmotion010 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AtezolizumabExperimental Treatment1 Intervention

Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,089,290 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the research say about Atezolizumab's efficacy?

"Atezolizumab was first studied in 2008 at A.O. Universitaria Pisana; Oncologia. Since then, there have been 18312 completed studies. Currently, 361 studies are actively recruiting, with a large number of these studies concentrated in New Haven, Connecticut."

Answered by AI

Could you please elaborate on how Atezolizumab might impact patients?

"Atezolizumab's safety is based on its efficacy data from Phase 3 trials and multiple rounds of safety data, giving it a score of 3."

Answered by AI

Are we currently enrolling people in this trial?

"Unfortunately, this specific trial is not currently recruiting patients. Although the last update to the listing was on September 12th, 2022, the original posting date was January 3rd, 2017. With that said, there are over 3000 other clinical trials that are currently looking for participants."

Answered by AI

What are the most common Atezolizumab treatments?

"Atezolizumab is a medication used to treat various conditions, such as small cell lung cancer, non-small cell lung carcinoma, and postoperative malignant neoplasms."

Answered by AI

Have similar experiments been conducted before this one?

"Atezolizumab has been the focus of 361 active clinical trials in 74 countries and 1668 cities since the first study in 2008. The sponsor, Genentech, Inc., completed a Phase 2 drug approval stage in 2008 with 720 patients. Since then, 18312 trials have completed."

Answered by AI

Recent research and studies

Clinical Genitourinary CancerJournal

Prevalence, Disease-free, and Overall Survival of Contemporary Patients with Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials

Marconi, Lorenzo, Maxine Sun, Christian Beisland, Tobias Klatte, Boerje Ljungberg, Grant D. Stewart, Saeed Dabestani, Toni K. Choueiri, and Axel Bex. 2021. “Prevalence, Disease-free, and Overall Survival of Contemporary Patients with Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials”. Clinical Genitourinary Cancer. Elsevier BV. doi:10.1016/j.clgc.2020.12.005.

The LancetJournal

Adjuvant Atezolizumab Versus Placebo for Patients with Renal Cell Carcinoma at Increased Risk of Recurrence Following Resection (immotion010): A Multicentre, Randomised, Double-blind, Phase 3 Trial

Pal, Sumanta Kumar, Robert Uzzo, Jose Antonio Karam, Viraj A Master, Frede Donskov, Cristina Suarez, Laurence Albiges, et al.. 2022. “Adjuvant Atezolizumab Versus Placebo for Patients with Renal Cell Carcinoma at Increased Risk of Recurrence Following Resection (immotion010): A Multicentre, Randomised, Double-blind, Phase 3 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)01658-0.

clinicaltrials.govStudy

A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

2017. "A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03024996.