TIRACAN; Open label phase 2 basket trial with Atezolizumab and Tiragolumab in solid tumors

Conditions

HNSCC, irresectable or metastatic melanoma, locally advanced or metastatic solid tumor, metastatic deficient mismatch repair (dMMR)/MSI-high (MSI-H) tumors

Brief summary

Pathologic response of the primary tumor (pTR) in patients with HNSCC and ORR according to (i)RECIST 1.1 in patients with advanced or metastatic dMMR/MSI cancer, metastatic melanoma and patients with a locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti-PD-L1 immunotherapy.

Detailed description

Safety assessment through: o Incidence, nature and severity of adverse events, including protocol-defined events of special interest such as described in section 10.1.6, graded according to NCI CTCAE 5.0 o Changes in laboratory test results, vital signs and physical findings., Assessment of DFS in patients with HNSCC. o DFS is defined as the time from surgery to the time of local, regional or distant disease recurrence or death, whichever comes first., Evaluation of ORR, PFS and DOR according to (i)RECIST, as assessed by the investigator for cohort 2, 3 and 4., The correlation between TIGIT, PD-1, PD-L1 and CD8 IHC expression on tumor tissue provided prior to start of treatment and inflammatory infiltrate with radiographic (CT or MRI) in cohort 2, 3, and pathologic response pTR in cohort 1 and 2.

Related papers

No related papers found yet.

Interventions

DRUGTiragolumab

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathologic response of the primary tumor (pTR) in patients with HNSCC and ORR according to (i)RECIST 1.1 in patients with advanced or metastatic dMMR/MSI cancer, metastatic melanoma and patients with a locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti-PD-L1 immunotherapy.	—

Secondary

Measure	Time frame
Safety assessment through: o Incidence, nature and severity of adverse events, including protocol-defined events of special interest such as described in section 10.1.6, graded according to NCI CTCAE 5.0 o Changes in laboratory test results, vital signs and physical findings., Assessment of DFS in patients with HNSCC. o DFS is defined as the time from surgery to the time of local, regional or distant disease recurrence or death, whichever comes first., Evaluation of ORR, PFS and DOR according to (i)RECIST, as assessed by the investigator for cohort 2, 3 and 4., The correlation between TIGIT, PD-1, PD-L1 and CD8 IHC expression on tumor tissue provided prior to start of treatment and inflammatory infiltrate with radiographic (CT or MRI) in cohort 2, 3, and pathologic response pTR in cohort 1 and 2.	—

Measure

Time frame

Safety assessment through: o Incidence, nature and severity of adverse events, including protocol-defined events of special interest such as described in section 10.1.6, graded according to NCI CTCAE 5.0 o Changes in laboratory test results, vital signs and physical findings., Assessment of DFS in patients with HNSCC. o DFS is defined as the time from surgery to the time of local, regional or distant disease recurrence or death, whichever comes first., Evaluation of ORR, PFS and DOR according to (i)RECIST, as assessed by the investigator for cohort 2, 3 and 4., The correlation between TIGIT, PD-1, PD-L1 and CD8 IHC expression on tumor tissue provided prior to start of treatment and inflammatory infiltrate with radiographic (CT or MRI) in cohort 2, 3, and pathologic response pTR in cohort 1 and 2.

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Countries

Netherlands

Outcome results

None listed