Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. hemoglobin ≥9.0 g/dL 2. platelet count ≥100 x 109 / 3. 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: 1. total bilirubin ≤1.5 x ULN (≤3 x ULN if liver tumor involvement);