Actively Recruiting
Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors
Led by University Medical Center Groningen · Updated on 2025-03-30
97
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this open label phase II trial combination therapy with the anti-PD-L1 antibody atezolizumab and the anti-TIGIT antibody tiragolumab will be investigated in patients with localized HNSCC who will undergo surgery, advanced or metastatic MSI-H cancer, PD-1 resistant metastatic melanoma, and patients with a locally advanced or metastatic solid tumor who, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti-PD-L1 and anti-TIGIT immunotherapy.
CONDITIONS
Official 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 according to standard clinical care.
- Measurable disease as defined by RECIST v1.1, excluding previously irradiated lesions.
- Ability to participate in the GE-269-001 CD8 investigational imaging trial if available.
- Signed informed consent.
- Age 18 years or older at time of 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 serum creatinine ≤1.5 times upper limit of normal or estimated glomerular filtration rate >30 mL/min/1.73 m2.
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal (or ≤3 times if liver tumor involvement), AST and ALT ≤2.5 times upper limit of normal (or ≤5 times if liver tumor involvement), ALP ≤2.5 times upper limit of normal (or ≤5 times if liver or bone tumor involvement).
- Ability to comply with the study protocol.
- Agreement to use highly effective contraception if applicable.
- For head and neck squamous cell carcinoma cohort: clinical T2-4a or node positive resectable HPV-unrelated HNSCC, no distant metastases, and no prior radiation to 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 chimeric or humanized antibodies.
- Any disease or condition that contraindicates the use of atezolizumab and tiragolumab or may affect study results or increase risk.
- Pregnant or breastfeeding women.
- Positive test for HIV, active hepatitis B or C infection (with specific testing requirements).
- Acute or chronic active Epstein-Barr virus infection.
- Active tuberculosis.
- Treatment with systemic immunostimulatory agents within 6 weeks prior to first dose.
- Treatment with systemic immunosuppressive medications within 2 weeks prior to first dose, with some exceptions.
- Presence of brain metastases or leptomeningeal metastases.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Daan G Knapen, MD
CONTACT
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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