Tislelizumab for Stomach Cancer

Recruiting at 97 trial locations

Overseen By BeiGene

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeOne Medicines

Must not be taking: Corticosteroids

Disqualifiers: Squamous cell, Brain metastasis, HER2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: Up to 2 years

351 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new drug, tislelizumab, for stomach cancer that cannot be surgically removed or has metastasized. Researchers aim to determine if administering the drug via a subcutaneous injection is as effective as an IV drip, both in combination with chemotherapy. The trial seeks participants with advanced stomach or gastroesophageal junction cancer who have not received prior treatment for their condition. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tislelizumab, whether administered as a shot under the skin or through an IV, generally maintains a safety profile similar to chemotherapy alone. Studies have found that combining tislelizumab with chemotherapy does not significantly increase the risk of serious side effects compared to chemotherapy alone.

For the IV form, some patients reported lung inflammation, occurring in about 4.7% of cases, with very few being severe. Overall, most side effects were manageable and not life-threatening.

The shot form has also been studied and did not worsen surgery-related complications in patients with advanced stomach cancer.

In summary, both forms of tislelizumab appear well-tolerated when used with chemotherapy, with side effects generally consistent with those expected from cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Tislelizumab for stomach cancer because it offers a new way to unleash the immune system against cancer cells. Unlike standard chemotherapy, which directly attacks cancer cells, Tislelizumab is an immunotherapy that works by blocking a protein called PD-1, helping the immune system recognize and destroy cancer cells more effectively. The trial is exploring two methods of delivery: a subcutaneous injection and an intravenous infusion, providing flexibility and potentially improved convenience for patients. This approach could enhance treatment effectiveness and offer new hope for those with advanced stomach cancer.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

Research shows that tislelizumab may help treat advanced stomach cancer. In this trial, participants will receive either Tislelizumab Subcutaneous with chemotherapy or Tislelizumab Intravenous Infusion with chemotherapy. Studies have found that combining tislelizumab with chemotherapy improved survival rates compared to chemotherapy alone. Specifically, one study reported a 93.5% response rate and a 100% disease control rate in patients with advanced stomach cancer. Another study demonstrated a 20% decrease in the risk of disease progression or death when using tislelizumab. These findings suggest that tislelizumab could be effective for treating advanced stomach and gastroesophageal junction cancers. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread. Participants will receive tislelizumab via injection or infusion plus chemotherapy.

Inclusion Criteria

At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment

I am fully active or can carry out light work.

My organs are working well.

Exclusion Criteria

My stomach cancer is squamous cell, undifferentiated, or another type.

Active autoimmune diseases or history of autoimmune diseases that may relapse

I don't need steroids for brain metastasis and have been stable for 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tislelizumab administered as a subcutaneous injection or intravenous infusion plus chemotherapy on Day 1 of each 21-day cycle

Up to 2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Leucovorin, Capecitabine, Cisplatin, 5-fluorouracil (5-FU), Oxaliplatin
• Tislelizumab

Trial Overview The study compares drug exposure levels between subcutaneous injection and intravenous infusion of Tislelizumab, combined with chemotherapy drugs like Leucovorin, Capecitabine, Cisplatin, 5-FU, and Oxaliplatin in around 351 patients.

How Is the Trial Designed?

Group I: Arm A: Tislelizumab Subcutaneous + Chemotherapy Experimental Treatment 6 Interventions

Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Group II: Arm B: Tislelizumab Intravenous Infusion + Chemotherapy Active Control 6 Interventions

Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40528576/

patient-reported outcomes in the RATIONALE-305 study Objective: RATIONALE-305 (NCT03777657) demonstrated that tislelizumab plus chemotherapy statistically improved overall survival versus placebo plus chemotherapy ...

2. onclive.com onclive.com/view/tislelizumab-plus-chemotherapy-is-active-tolerable-in-advanced-gastric-gej-cancer

Tislelizumab Plus Chemotherapy Is Active, Tolerable in ... Tislelizumab plus POFI showed promising efficacy in advanced gastric cancer with a 93.5% objective response rate and 100% disease control rate.

3. oncologynewscentral.com oncologynewscentral.com/drug/fda-approves-tislelizumab-combo-for-gastric-or-gastroesophageal-junction-cancer

FDA Approves Tislelizumab Combo for Gastric or ... Results showed that adults with advanced unresectable or metastatic gastric and GEJ cancers who received tislelizumab plus the investigator's ...

4. targetedonc.com targetedonc.com/view/tislelizumab-scores-fda-approval-in-advanced-gastric-and-gej-cancers

Tislelizumab Scores FDA Approval in Advanced Gastric ... In the study, tislelizumab given in combination with chemotherapy demonstrated a 20% reduction in the risk of disease progression or death.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2605

Tislelizumab first-line (1L) gastric/gastroesophageal ... Tislelizumab was associated with a 21% reduction in risk of death (P=0.0269). Conclusions: In this analysis, compared with chemo, tislelizumab + ...

6. tevimbrahcp.com tevimbrahcp.com/gc/safety/

1L GC/GEJC Safety | TEVIMBRA® (tislelizumab-jsgr) | HCPs Immune-mediated pneumonitis occurred in 4.7% (113/2390) of patients receiving TEVIMBRA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (1.4%), and Grade 2 (1.9 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761417s000lbl.pdf

TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use TEVIMBRA may be used alone when your esophageal cancer: o is a type called squamous cell carcinoma, and o cannot be removed with surgery or has spread to other ...

8. reference.medscape.com reference.medscape.com/drug/tevimbra-tislelizumab-4000247

Tevimbra (tislelizumab) dosing, indications, interactions, ... Medscape - Esophageal and gastric cancer dosing for Tevimbra (tislelizumab), frequency-based adverse effects, comprehensive interactions, contraindications, ...

9. es.aetna.com es.aetna.com/cpb/medical/data/1000_1099/1057.html

Tislelizumab-jsgr (Tevimbra) - Medical Clinical Policy ... Aetna considers tislelizumab-jsgr (Tevimbra) medically necessary for treatment of HER2-negative gastric adenocarcinoma in members who are not surgical ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/tislelizumab-jsgr-intravenous-route/description/drg-20565521

Tislelizumab-jsgr (intravenous route) - Side effects & uses Tislelizumab-jsgr injection is used in combination with platinum-containing chemotherapy as first-line treatment of esophageal squamous cell carcinoma (ESCC)