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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tiragolumab and atezolizumab
Drugthree weekly tiragolumab 1200 mg intravenous plus tiragolumab 600 mg intravenous.
Treatment groups
97 Participants
are divided into 4 treatment groupsGroup A: Localized Head and Neck Squamous Cell CancerExperimental treatment 1 intervention
Group B: Advanced or Metastatic dMMR/MSI CancerExperimental treatment 1 intervention
Group C: Anti-PD-1 Antibody Resistant Metastatic MelanomaExperimental treatment 1 intervention
Group D: BasketExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathologic response in cohort 1
pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor): pTR-0 (\<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
Time frame
At the time of resection of the tumor which is day 36-43 after the first course of therapy2
Best overall response rate in cohort 2-4
Overall response rate according to (i)RECIST 1.1
Time frame
From date of randomization until the date of first documented progression or after a maximum of two years of treatmentSecondary outcomes
1
Clinical safety
Incidence, nature and severity of adverse events, including protocol-defined events of special interest according to NCI CTCAE 5.0
Time frame
Through study completion, a maximum of 24 months2
Disease free survival in cohort 1
DFS is defined as the time from surgery to the time of local, regional or distant disease recurrence or death, whichever comes first.
Time frame
The time from surgery to the time of local, regional or distant disease recurrence or death, whichever comes first put or 60 months3
Progression free survival
Evaluation of progression free survival according to (i)RECIST, as assessed by the investigator for cohort 2, 3 and 4
Time frame
PFS is defined as the time from the first full treatment dose of atezolizumab and tiragolumab to time of disease progression or death due to any cause, whichever occurs first within a timeframe of 60 months4
Overall response rate
Evaluation of overall response rate according to (i)RECIST, as assessed by the investigator for cohort 2, 3 and 4
Time frame
ORR is defined as the proportion of subjects whose best overall response is either a PR or CR, as assessed by the investigator during a maximum of 24 months on treatmentSponsors and contacts
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Source ClinicalTrials.gov