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)

Solid Tumors Clinical Trial

— IMperator  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331598
• Other study ID #: ML43332
• Secondary ID: 2022-003708-33
• Status: Recruiting
• Phase: Phase 2
• Start date: July 30, 2024
• Est. completion date: September 20, 2029

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML43332 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 20, 2029
• Est. primary completion date: October 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Microsatellite Instability
• Recurrence
• Solid Tumors

Intervention

Drug:
• Atezolizumab
A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
• Tiragolumab
A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall dHebron; Oncology	Barcelona
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Virgen; Servicio de Oncologia	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS) Rate at 24 Months		Month 24
Secondary	DFS Rate at 36, 48 and 60 Months		Months 36, 48, 60
Secondary	OS (Overall Survival)		From randomization to death from any cause (up to approximately 60 months)
Secondary	Percentage of Participants With Adverse Events		Up to approximately 60 months