About this trial
This clinical trial is looking at a drug called atezolizumab. Atezolizumab is approved as standard of care treatment for adult patients with urothelial cancer, non-small cell lung cancer, extensive-stage small cell lung cancer, hepatocellular carcinoma and triple negative breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Atezolizumab works in patients with these types of cancers which have certain changes in the cancer cells called high tumour mutational burden (TMB) or high microsatellite instability (MSI) or proven (previously diagnosed) constitutional mismatch repair deficiency (CMMRD).
Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also TMB/MSH-high or show CMMRD. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.
This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.
Eligibility criteria
Qualifiers
None
Disqualifiers
Have a negative serum or urine pregnancy test before enrolment and;
Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.
Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception.
Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.
Trial design
Treatments tested in this trial
- Atezolizumab
Treatment groups
Locations
27Sponsors and collaborators
Cancer Research UK
Lead sponsor
University of Manchester
Collaborator
University of Birmingham
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
Hoffmann-La Roche
Collaborator