← Back to Search

Monoclonal Antibodies

Atezolizumab for Prostate Cancer (IMbassador250 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 months 12, 24

Awards & highlights

IMbassador250 Trial Summary

This trial is testing whether atezolizumab (an anti-cancer drug) in combination with enzalutamide (a cancer drug) is better than enzalutamide alone in treating people with mCRPC (a type of prostate cancer) after the cancer has progressed despite treatment with other drugs.

Eligible Conditions

Castration-resistant Prostate Cancer

IMbassador250 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 12, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 12, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 12, 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Maximum Observed Serum Concentration (Cmax) of Atezolizumab

Minimum Observed Serum Concentration (Cmin) of Atezolizumab

Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria

+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

IMbassador250 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + EnzalutamideExperimental Treatment2 Interventions

Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).

Group II: EnzalutamideActive Control1 Intervention

Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Enzalutamide

2014

Completed Phase 4

~2760

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

1,089,296 Total Patients Enrolled

2 Trials studying Prostate Cancer

119 Patients Enrolled for Prostate Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,168 Total Patients Enrolled

3 Trials studying Prostate Cancer

417 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Has Atezolizumab received approval from the FDA?

"There is both evidence of efficacy and multiple rounds of data affirming safety, so Atezolizumab scored a 3 on our safety scale."

Answered by AI

What are Atezolizumab's most popular applications?

"Atezolizumab, which is most often used to treat small cell lung cancer, can also be an effective treatment method for castration, malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

Could you compare and contrast this clinical trial to others involving Atezolizumab?

"462 different clinical trials are currently underway that involve Atezolizumab. Out of those, 101 are in Phase 3. However, most of the trials are not based in Houston, Texas as 24572 different locations are running trials for this treatment."

Answered by AI

Can you give me a number of how many locations are participating in this experiment?

"There are a total of 47 sites where this study is being conducted. Some of these locations include: Associates in Oncology/Hematology P.C. in Rockville, Stamford Hospital; BCC, MOHR in Stamford, and Miriam Hospital in Providence."

Answered by AI

Recent research and studies

Nature MedicineJournal

Atezolizumab with Enzalutamide Versus Enzalutamide Alone in Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial

Powles, Thomas, Kobe C. Yuen, Silke Gillessen, Edward E. Kadel III, Dana Rathkopf, Nobuaki Matsubara, Charles G. Drake, et al.. 2022. “Atezolizumab with Enzalutamide Versus Enzalutamide Alone in Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01600-6.

clinicaltrials.govStudy

A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen

2017. "A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03016312.