Actively Recruiting
Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors: TIRACAN
Led by University Medical Center Groningen · Updated on 2025-03-30
97
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of two immunotherapy drugs, atezolizumab (anti-PD-L1 antibody) and tiragolumab (anti-TIGIT antibody), in patients with various solid tumors. This open-label phase II trial includes patients with localized head and neck squamous cell carcinoma (HNSCC) undergoing surgery, advanced or metastatic microsatellite instability-high (MSI-H) cancer, PD-1 resistant metastatic melanoma, and those with locally advanced or metastatic solid tumors who might benefit from this treatment. The goal is to assess the anti-tumor activity, safety, and tolerability of this combination and explore protein markers that might predict treatment response. Participants will receive intravenous infusions of tiragolumab 1200 mg plus atezolizumab 600 mg every three weeks. Treatment continues until surgery (after two courses) for HNSCC patients, resectable disease in MSI-H tumors, disease progression or side effects, or a maximum of two years. Tissue samples will be collected at baseline, during treatment, and at surgery. Blood samples will monitor circulating tumor DNA, and imaging scans (CT or MRI) will track tumor response. Throughout the trial, participants will undergo regular evaluations including tumor biopsies, imaging to measure treatment response, and laboratory tests to monitor safety and immune markers. The primary outcomes are pathological response in HNSCC patients at surgery and radiological response in other cohorts. Secondary outcomes include safety assessments, disease-free survival, progression-free survival, overall response rates, duration of response, and correlation of specific protein expressions with treatment outcomes. The study is led by the University Medical Center Groningen and will continue until 2027.
CONDITIONS
Brief Title
Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor lesion(s) that can be safely biopsied
- Measurable disease according to RECIST v1.1 criteria
- Participation in the GE-269-001 CD8 investigational imaging trial if slots are available
- Signed informed consent
- Age 18 years or older at consent
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function including hemoglobin ≥9.0 g/dL, platelet count ≥100 x 10^9/L, and adequate kidney function
- Adequate liver function with limits on bilirubin, AST, ALT, and alkaline phosphatase levels
- Ability to comply with the study protocol
- Agreement to use highly effective contraception if patient or partner is of childbearing potential
- For HNSCC patients: clinical T2-4a or node positive resectable HPV-unrelated HNSCC, no distant metastases, and no prior radiation to the head and neck region
You will not qualify if you...
- Signs or symptoms of infection within 2 weeks before starting treatment
- Prior treatment with immune checkpoint inhibitors (anti-PD1 or anti-PD-L1) for cohorts 1, 2, and 4
- History of severe allergic or hypersensitivity reactions to antibodies or fusion proteins
- Other diseases or conditions that increase risk or interfere with study results
- Pregnant or breastfeeding women
- Positive tests for HIV, active hepatitis B or C infections
- Active Epstein-Barr virus infection at screening
- Active tuberculosis
- Treatment with systemic immunostimulatory agents within 6 weeks before first dose
- Treatment with systemic immunosuppressive medications within 2 weeks before first dose, with some exceptions
- Presence of brain or leptomeningeal metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until surgery, disease progression, or treatment termination
Participants receive atezolizumab and tiragolumab every 3 weeks. Treatment continues until surgery for localized HNSCC after 2 courses, until disease progression or side effects for other cohorts, or up to a maximum of 2 years.
Infusions every 3 weeks with regular CT or MRI scans to monitor response
Duration - Approximately 1 week around day 36-43 after first treatment
Participants with localized HNSCC undergo tumor resection after 2 courses of treatment.
1 surgery visit with immediate post-operative care
Duration - Up to 60 months
Participants are monitored for safety, disease recurrence, and treatment response after treatment ends or surgery is completed.
Regular follow-up visits including imaging and assessments
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
D
Derk JA de Groot, Md PhD
D
Daan G Knapen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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