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)

NCT06331598 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: ML433322022-003708-33
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS) Rate at 24 Months

  Month 24

Secondary Outcomes (3)

• DFS Rate at 36, 48 and 60 Months

  Months 36, 48, 60

• OS (Overall Survival)

  From randomization to death from any cause (up to approximately 60 months)

• Percentage of Participants With Adverse Events

  Up to approximately 60 months

Study Arms (2)

Atezolizumab

EXPERIMENTAL

Participants will be treated with atezolizumab every 4 weeks (Q4W) for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).

Drug: Atezolizumab

Atezolizumab + Tiragolumab

EXPERIMENTAL

Participants will be treated with atezolizumab and tiragolumab Q4W for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, information on survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).

Drug: Atezolizumab; Drug: Tiragolumab

Interventions

Atezolizumab DRUG

A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

Also known as: Tecentriq

Atezolizumab; Atezolizumab + Tiragolumab

Tiragolumab DRUG

A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

Also known as: MTIG7192A

Atezolizumab + Tiragolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Hospital Universitari Vall dHebron; Oncology

Barcelona, BARCELONA, 08035, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Virgen; Servicio de Oncologia

Seville, SEVILLA, 41013, Spain

Location

MeSH Terms

Interventions

atezolizumab; Tiragolumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): September 20, 2029
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (3)