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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

Study acronym: DETERMINE
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 152 words Study description expanded, about 3 wordsv6 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 26 to 27 Eligibility criteria expanded, about 63 words · Secondary endpoints revised (13) · Study title revised · 1 morev5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints revised (13)
    • Study title revised
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date changed from estimate of Nov 2023 to Oct 25, 2023v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2023 to Nov 2023 · Site details revised at 26 of 26 sitesv3 Show 2 more changesShow less
    • Start date: Sep 2023 to Nov 2023
    • Site details revised at 26 of 26 sites
  5. Start date: Apr 2023 to Sep 2023 Eligibility criteria revised · Study description revised · Site contacts updated at 1 of 26 sites · 1 morev2 Show 4 more changesShow less
    • Eligibility criteria revised
    • Study description revised
    • Site contacts updated at 1 of 26 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05770102
Lead Sponsor Cancer Research UK
Collaborators: University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, Hoffmann-La Roche
Conditions Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type, Neoplasms by Site, Cancer, Colorectal Neoplasms, Endometrial Neoplasms +2 more
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov