Clinical trial NCT06331598: 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)
Official title: A Phase II, Open Label, Randomized, Non-Comparative Cohorts 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Disease Free Survival (DFS) Rate at 24 Months
timeFrame: Month 24
Secondary outcomes:
measure: DFS Rate at 36, 48 and 60 Months
timeFrame: Months 36, 48, 60
measure: OS (Overall Survival)
timeFrame: From randomization to death from any cause (up to approximately 60 months)
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 60 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall dHebron; Oncology
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen; Servicio de Oncologia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: