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New treatment option for Malignancy
Official title 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
ClinicalTrials.gov ID: NCT05770102
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignancy.
Also referred to as Tecentriq.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB)...
- \ When atezolizumab-specific inclusion/
You likely can't join if
- or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence. Inclusion Criteria...
- Have a negative serum or urine pregnancy test before enrolment and;
- Agree to use one form of effective birth control method such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated...
- 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...
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the...
See the full eligibility criteria
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 02 (ATEZOLIZUMAB) OUTLINED BELOW\
- \ When atezolizumab-specific inclusion/
- or precautions below differ from those specified in the Master Protocol, the atezolizumab-specific criteria will take precedence. Inclusion Criteria: A. Confirmed diagnosis of a malignancy that is high TMB (defined as...
- Have a negative serum or urine pregnancy test before enrolment and;
- Agree to use one form of effective birth control method such as: I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation ([oral, intravaginal or transdermal])...
- 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. All male patients must refrain from donating sperm...
- Paediatric patients with either primary brain tumours or extracranial solid tumours with intracranial metastases with one or more intracranial lesions should only be considered for inclusion if largest intracranial...
- History of idiopathic pulmonary fibrosis, organising pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- Evidence of active pneumonitis on screening chest computed tomography (CT) scan. E. Active autoimmune disease that requires the use of systemic immunomodulatory therapy (i.e. with disease modifying agents...
- Patients who received acute, low dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g. 48 hours of corticosteroids for a contrast allergy) are eligible for...
- Patients who received corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma equivalent to ≤10 mg prednisolone a day or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- Patients with primary CNS disease can be receiving concurrent treatment with corticosteroids. Patients must be receiving a stable or decreasing dose for ≥14 days for adults and ≥7 days for paediatric patients prior to...
- Patients who receive physiological doses of steroid replacement (e.g. hydrocortisone) are permitted. H. Known to be serologically positive (as detected by polymerase chain reaction) for hepatitis B, hepatitis C or human...
- Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of atezolizumab, and patients with punctate CNS haemorrhages \<3 mm may be considered...
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Metropolitan Borough of Wirral, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom; Edinburgh, United Kingdom and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.