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Stomach NeoplasmsPhase 2NCT04933227

A Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

A Phase 2 study testing Atezolizumab, Tiragolumab and Oxaliplatin in people with Stomach Neoplasms and Gastric Cancer, run by Hoffmann-La Roche at 11 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Tiragolumab and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
11 sitesChina
Study dates
6 Aug 2021to 17 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed (by enrolling center) gastric cancer or adenocarcinoma of GEJ (Siewert I-III)
  • Unresectable locally advanced, unresectable recurrent, or metastatic disease that meets the following criteria: a) No prior systemic treatment for advanced disease, b) For patients receiving prior chemoradiotherapy or chemotherapy in the adjuvant or neoadjuvant setting, with an interval of at least 6 months between the final treatment and the diagnosis of advanced disease
  • Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as determined by investigator assessment
  • Availability of a representative tumor specimen that is suitable for determination of PD-L1 and TIGIT expression
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >/=3 months
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  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to refrain from heterosexual intercourse or use contraception, and agreement to refrain from donating eggs
  • For men: agreement to refrain from heterosexual intercourse or use contraceptive methods, and agreement to refrain from donating sperm.

Who cannot join

  • HER2-positive by local review, defined as either immunohistochemistry (IHC) score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed based on pretreatment tumor tissues
  • Use of Chinese herbal medicine or Chinese patent medicines to control cancer within 7 days prior to initiation of study treatment
  • Higher risk of bleeding or fistula caused by GEJ Siewert I invading adjacent organs
  • Symptomatic, untreated, or actively progressing CNS metastases
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
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  • Uncontrolled or symptomatic hypercalcemia
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
  • Severe chronic or active infection within 4 weeks prior to initiation of study treatment
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
  • Any other disease, medical condition, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination finding, clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-TIGIT therapeutic antibodies
  • Treatment with systemic immunostimulatory agents or any investigational therapy within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
  • Known allergy or hypersensitivity to any component of atezolizumab, tiragolumab, capecitabine or oxaliplatin formulations
  • Pregnant or breastfeeding.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, 132013

  • Hunan Cancer Hospital

    Changsha, 410013

  • Changzhou First People's Hospital

    Changzhou, 213003

  • The First Affiliated Hospital of College of Medicine, Zhejiang University; Medical Oncology

    Hangzhou, 310003

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Anhui Province Cancer Hospital

    Hefei, 230031

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

Other trials in China

About this study

Official title: A Phase II, Single-Arm Study to Explore the Efficacy and Safety of Atezolizumab Plus Tiragolumab and Chemotherapy in 1st Line HER2 Negative Unresectable, Recurrent or Metastatic Gastric Cancer or Adenocarcinoma of Gastroesophageal Junction (GEJ)

This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).

Being tested
Atezolizumab, Tiragolumab, Oxaliplatin, Capecitabine
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.

  • TiragolumabDrug

    Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.

  • CapecitabineDrug

    Capecitabine 1000 mg/m^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.

Study groups in NCT04933227
Study groupRoleWhat they receive
Atezo + Tira + XELOXExperimentalAtezolizumab plus tiragolumab in combination with XELOX (oxaliplatin and capecitabine) will be administered during Cycles 1-4 (each cycle is 21 days). During Cycle 5 and beyond atezolizumab and tiragolumab will be administered on Day 1 of each 21-day cycle. Participants will receive study treatment until disease progression, unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Receives: Drug: Atezolizumab; Drug: Tiragolumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population

    Measured: Up to approximately 20 months

Secondary outcomes (12)

  1. Duration of Response (DOR) in Responders of the FAS Population

    Measured: The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

  2. Progression-free Survival (PFS) in the FAS Population

    Measured: The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

  3. Overall Survival (OS) in the FAS Population

    Measured: The time from initiation of study treatment to death due to any cause up to approximately 20 months

  4. Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the FAS Population

    Measured: Up to approximately 20 months

  5. Change from Baseline in EORTC QLQ-C30 in the FAS Population

    Measured: Up to approximately 20 months

  6. Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire in Gastric Cancer (EORTC QLQ-STO22) in the FAS Population

    Measured: Up to approximately 20 months

  7. Change from Baseline in EORTC QLQ-STO22 in the FAS Population

    Measured: Up to approximately 20 months

  8. ORR in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression

    Measured: Up to approximately 20 months

  9. Duration of Response (DOR) in Responders of a Subgroup Population With PD-L1 and/or TIGIT Positive Expression

    Measured: The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

  10. Progression-free Survival (PFS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression

    Measured: The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months

  11. Overall Survival (OS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression

    Measured: The time from initiation of study treatment to death due to any cause up to approximately 20 months

  12. Number of Participants With Adverse Events

    Measured: Up to approximately 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2021
  2. Study start6 Aug 2021
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 2023

Why it stopped: Sponsor's decision to terminate the study after Stage 1; will not proceed with Stage 2.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04933227
Sponsor's protocol ID
ML42913
Status last verified
Nov 2024
First submitted
17 Jun 2021
Last updated
14 Nov 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Tiragolumab and Oxaliplatin in people with Stomach Neoplasms and Gastric Cancer, run by Hoffmann-La Roche at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's decision to terminate the study after Stage 1; will not proceed with Stage 2.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population (time frame: Up to approximately 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04933227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.

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