Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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
Qualifiers
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.
Disqualifiers
Signs or symptoms of infection within 2 weeks prior to atezolizumab and tiragolumab administration.
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.
Trial design
Treatments tested in this trial
- Tiragolumab and atezolizumab
Treatment groups
97 Participants
are divided into 4 treatment groupsLocations
1University Medical Center Groningen9713 GZ, Groningen Netherlands
Sponsors and collaborators
University Medical Center Groningen
Lead sponsor
Source ClinicalTrials.gov