Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors: TIRACAN
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.
• Tumor lesion(s) of which a histological biopsy can be safely obtained according to standard clinical care procedures.
• 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 defined as:
‣ hemoglobin ≥9.0 g/dL
⁃ platelet count ≥100 x 109 /
⁃ 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.
• Adequate hepatic function defined as:
‣ 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.
• 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 RT to the head and neck region