Open Label - Cabozantinib & atezolizumab vs NHT in prostate cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer
IRAS ID
1003064
Contact name
Deborah Enting
Contact email
Sponsor organisation
Exelixis, Inc
Eudract number
2020-000348-77
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is the most common cancer among men and the second leading cause of
cancer deaths in the US. In 2018, it affected 1.3 million men worldwide and accounted
for 7.1% of all new cancer diagnoses that year.
The purpose of this study is to find out whether cabozantinib in combination with
atezolizumab is effective in treating prostate cancer compared with a second NHT
(abiraterone or enzalutamide). This study involves male participants that have metastatic
castration-resistant prostate cancer and their cancer has progressed after already
receiving a novel hormonal therapy (NHT, such as abiraterone, enzalutamide,
apalutamide or darolutamide).
The combination of cabozantinib and atezolizumab is currently being used in ongoing
clinical studies. More than 500 participants have received this combination to date, with
more than 50 of these participants having prostate cancer. To date, this combination has
been generally well-tolerated.
The study consists of three periods:
1. Screening Period – screening procedures to ensure participants meet the study
eligibility criteria
2. Treatment Period – study visits will be every 3 weeks (or more frequent if participants
experience side effects)
3. Post-Treatment – safety follow-up visits will be required approximately 30 days and
then again at approximately 100 days
A maintenance period (where participants continue to receive study medication) may
also occur.
If participants meet all study requirements, they will be randomly assigned to one of two
treatment groups and have a 50:50 chance of receiving either cabozanitib with
atezolizumab (Group 1), or NHT - abiraterone or enzalutimade (Group 2). Participants
will receive study medication for 4-8 months although this may be extended should
participants continue to benefit from the treatment. Study procedures will include blood
and urine tests, tumour biopsy samples, CT/MRI and bone scans, quality of Life
questionnaires, pain assessments and electrocardiograms. Exelixis Inc., is the sponsor of
this study.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0886
Date of REC Opinion
11 Aug 2020
REC opinion
Further Information Favourable Opinion