Open Label Phase 2 Basket Trial With Atezolizumab and Tiragolumab in Solid Tumors

Sponsor
University Medical Center Groningen
Study ID
NCT05483400
Phase
PHASE2
Status
Recruiting
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Conditions

  • Head and Neck Neoplasms
  • MSI-H Cancer
  • Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 18, 2023
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Localized Head and Neck Squamous Cell Cancer
    three weekly tiragolumab 1200 mg intravenous plus tiragolumab 600 mg intravenous
  • Experimental: Advanced or Metastatic dMMR/MSI Cancer
    three weekly tiragolumab 1200 mg intravenous plus tiragolumab 600 mg intravenous
  • Experimental: Anti-PD-1 Antibody Resistant Metastatic Melanoma
    three weekly tiragolumab 1200 mg intravenous plus tiragolumab 600 mg intravenous
  • Experimental: Basket
    three weekly tiragolumab 1200 mg intravenous plus tiragolumab 600 mg intravenous

Primary Outcome Measure

Pathologic response in cohort 1 [ Time Frame: At the time of resection of the tumor which is day 36-43 after the first course of therapy ]

Central Contacts

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