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TIRACAN; Open label phase 2 basket trial with Atezolizumab and Tiragolumab in solid tumors
EU CTIS ID: 2024-512616-21-00
What this study is testing
1. To determine pathological response rate (pTR) in patients in cohort 1 with localized HNSCC. 2. To determine the response rates in patients in cohort 2, 3, and 4 with advanced or metastatic dMMR/MSI cancer, PD-1 resistant metastatic melanoma, and with a locally advanced or metastatic solid tumor who, in the investigator’s opinion, based on available clinical data, may benefit from treatment with atezolizumab and tiragolumab.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Tumor lesion(s) of which a histological biopsy can be safely obtained according to standard clinical care procedures.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by the patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (1% per year) when used consistently and correctly.
- For the head and neck squamous cell carcinoma cohort specific eligibility criteria apply • clinical T2-4a, or node positive resectable HPV-unrelated HNSCC (oral cavity, larynx, hypopharynx, p16-negative oropharynx or p16 negative unknown primary) • no evidence of distant metastases. • no previous radiotherapy to the head and neck region.
- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions should be discarded as target lesions.
- Participate in the GE-269-001 CD8 investigational imaging trial provided that there are slots is that trial.
- Signed informed consent.
You likely can't join if
- Signs or symptoms of infection within 2 weeks prior to atezolizumab and tiragolumab administration.
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to cycle 1, day 1, with the exception of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for subjects with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids are allowed.
- medications (e.g., a one-time dose of dexamethasone for nausea) may be allowed in the study after discussion with and approval by the principal investigator (PI).
- Brain metastases, leptomeningeal metastases.
- Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti- PD-L1 antibodies (only for cohort 1, 2 and 4).
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
See the full eligibility criteria
Who can join
- Tumor lesion(s) of which a histological biopsy can be safely obtained according to standard clinical care procedures.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by the patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (1% per year) when used consistently and correctly.
- For the head and neck squamous cell carcinoma cohort specific eligibility criteria apply • clinical T2-4a, or node positive resectable HPV-unrelated HNSCC (oral cavity, larynx, hypopharynx, p16-negative oropharynx or p16 negative unknown primary) • no evidence of distant metastases. • no previous radiotherapy to the head and neck region.
- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions should be discarded as target lesions.
- Participate in the GE-269-001 CD8 investigational imaging trial provided that there are slots is that trial.
- Signed informed consent.
- Age ≥18 at the time of signing informed consent.
- Life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ and bone marrow function as defined below: o Hemoglobin ≥9.0 g/dL. o Platelet count ≥100 x 109 /L. o Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate > 30 mL/min/1.73 m2 . A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria. o Adequate hepatic function: ▪ Total bilirubin ≤1.5 x ULN (≤3 x ULN if liver tumor involvement); Patients with Gilbert’s syndrome do not need to meet total bilirubin requirements, provided their total bilirubin is unchanged from their baseline. Gilbert’s syndrome must be documented appropriately as past medical history. ▪ Aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 x ULN if liver tumor involvement) ▪ Alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver tumor involvement) ▪ Alkaline phosphatase (ALP) ≤2.5 x ULN (≤5 x ULN if liver or bone tumor involvement)
- Ability to comply with the protocol.
What rules you out
- Signs or symptoms of infection within 2 weeks prior to atezolizumab and tiragolumab administration.
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to cycle 1, day 1, with the exception of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for subjects with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids are allowed.
- medications (e.g., a one-time dose of dexamethasone for nausea) may be allowed in the study after discussion with and approval by the principal investigator (PI).
- Brain metastases, leptomeningeal metastases.
- Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti- PD-L1 antibodies (only for cohort 1, 2 and 4).
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use atezolizumab and tiragolumab, or that may affect the interpretation of the results or render the patient at high risk from complications.
- Pregnant or lactating women.
- Positive test for HIV, active hepatitis B (chronic or acute defined by positive hepatitis B surface antigen (HBsAg) during screening) or hepatitis C. Patients with a medical history of hepatitis B infection (defined as a positive hepatitis B core antibody (HBcAb) and absence of an HBsAg) are eligible for this study. Patients who test positive for hepatitis C antibodies are only eligible with a negative hepatitis C RNA PCR.
- Acute or chronic active EBV infection at screening EBV status should be assessed by EBV serology (e.g., anti-VCA IgM and IgG, anti-EA IgG, anti-EBNA IgG) and EBV PCR (plasma or serum). If EBV serology results indicate prior EBV infection, patients must have a negative EBV PCR (plasma or serum) to be eligible for the study.
- Active tuberculosis.
- Treatment with systemic immunostimulatory agents (including but not limited to IFNs, IL- 2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to the first full dose of atezolizumab and tiragolumab.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.