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

Sponsor
Cancer Research UK
Study ID
NCT05770102
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Colorectal Neoplasms
  • Endometrial Neoplasms
  • Lymphoproliferative Disorders
  • Malignancy
  • Malignant Neoplasm
  • Melanoma
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Adult patients will receive 1200 mg of atezolizumab intravenously every 21 days. Paediatric patients will receive atezolizumab at a dose of 15 mg/kg (maximum 1200 mg) every 21 days. Patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Nov 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 02: Atezolizumab
    This atezolizumab treatment arm is for adult, paediatric and TYA patients with cancers with high TMB or high MSI or proven (previously diagnosed) CMMRD.

Primary Outcome Measure

Objective Response (OR) [ Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment. ]

Central Contacts

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