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Trial Title:
A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)
NCT ID:
NCT06331598
Condition:
Solid Tumors
Conditions: Official terms:
Recurrence
Microsatellite Instability
Atezolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day
cycle for a total of 12 cycles.
Arm group label:
Atezolizumab
Arm group label:
Atezolizumab + Tiragolumab
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
Tiragolumab
Description:
A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day
cycle for a total of 12 cycles.
Arm group label:
Atezolizumab + Tiragolumab
Other name:
MTIG7192A
Summary:
This study is being conducted to evaluate efficacy parameters (disease free survival
[DFS] and overall survival [OS]) of atezolizumab and atezolizumab in combination with
tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended
treatment in participants with intermediate-high risk of recurrence.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Any of the following solid tumors considered to be resectable with a curative
intent: non-small cell lung cancer, skin melanoma, skin squamous cell carcinoma,
urothelial carcinoma, colorectal cancer, gastric cancer, endometrial cancer, cervix
cancer, head and neck cancer and any other tumor type with known high TMB (≥ 13
mut/MB) or MSI-H
- Participants must undergo standard treatment according to the stage of their disease
and investigator´s choice
- All participants must be disease free after standard therapy to be included in this
study
- Having TMB ≥ 13 mut/MB or MSI-H in tumor tissue biopsy obtained prior to starting
standard treatment or from surgical specimens and analyzed using F1 CDx
- Participants must be at intermediate/high risk of recurrence
- Adequate hematologic and organ function
- Female participants of childbearing potential and male participants with female
partners of childbearing potential must be willing to avoid pregnancy
- Women who are not postmenopausal or surgically sterile must have a negative serum
pregnancy test result within 8 days prior to initiation of study drug.
Exclusion Criteria:
- Previous malignancies within 3 years prior to enrollment, with the exception of
those with a negligible risk of metastasis or death treated with expected curative
outcome
- Prior cancer immunotherapy
- Women who are pregnant, lactating, or intending to become pregnant during the study
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan
- Significant cardiovascular disease
- Treatment with systemic immunosuppressive medications within 2 weeks prior to
inclusion
- Treatment with systemic immunostimulatory agents within 4 weeks or 5
drug-elimination half-lives of the drug, whichever is longer, prior to
randomization.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitari Vall dHebron; Oncology
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen; Servicio de Oncologia
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Start date:
November 30, 2024
Completion date:
September 20, 2029
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331598