DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCancer Research UK

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

30 Participants
are divided into 1 treatment group

Locations

27
Belfast City HospitalBT9 7AB, Belfast United Kingdom
Birmingham Children's Hospital Birmingham United Kingdom
University Hospital BirminghamB15 2TT, Birmingham United Kingdom
Bristol Haematology and Oncology CentreBS2 8ED, Bristol United Kingdom

Sponsors 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