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

First listed
Aug 2, 2022
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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