Pumitamig + Chemotherapy vs Nivolumab + Chemotherapy for Stomach Cancer

(ROSETTA GI 204 Trial)

Not yet recruiting at 144 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: CNS metastases, Cardiovascular disease, Coagulation disorders, others

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

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 33 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for individuals with advanced or metastatic stomach cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. It evaluates the safety and effectiveness of Pumitamig (a new potential drug) plus chemotherapy against Nivolumab (an immunotherapy drug) plus chemotherapy. Participants must not have received previous systemic treatment for their advanced cancer and must have confirmed stomach or related cancer with specific characteristics, such as being HER2-negative (a protein absent in certain cancer cells). The trial targets those diagnosed with these conditions who have not yet begun treatment for advanced disease. As a Phase 2, Phase 3 trial, this study is crucial for assessing the treatment's effectiveness in a larger group and serves as a final step before potential FDA approval, offering participants a chance to contribute to groundbreaking cancer research.

Will I have to stop taking my current medications?

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?

A previous study found Pumitamig combined with chemotherapy to be generally safe, with no new safety issues and only a few discontinuations due to side effects. Research on Nivolumab with chemotherapy has shown it is usually well-tolerated. In one study, only 22% of patients experienced serious side effects. Both treatments have been tested in people with advanced stomach and related cancers, and the results suggest they are relatively safe options. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pumitamig combined with chemotherapy for stomach cancer because it offers a novel approach compared to standard treatments like chemotherapy alone or in combination with drugs like Nivolumab. Pumitamig works differently by potentially targeting specific pathways involved in stomach cancer growth, which could enhance its effectiveness. This might mean improved outcomes for patients who don't respond well to existing therapies. Additionally, combining Pumitamig with chemotherapy could provide a more comprehensive attack on cancer cells, offering new hope for better results.

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

This trial will compare the effectiveness of Pumitamig combined with chemotherapy to Nivolumab combined with chemotherapy for stomach cancer. Studies have shown that combining Nivolumab with chemotherapy can help patients with advanced stomach and gastroesophageal junction cancer live longer and delay disease progression. One study found that this combination improved survival rates more than chemotherapy alone.

In contrast, early research on Pumitamig combined with chemotherapy suggests it is generally safe, with few patients discontinuing treatment due to side effects. However, less information is available about Pumitamig's effectiveness compared to Nivolumab, as it remains under study. This trial will explore the potential benefits of both treatments for patients with these types of cancers. ^{1 2 3 4 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma who haven't been treated before. Specific eligibility criteria are not provided but typically include factors like age, overall health status, and cancer stage.

Inclusion Criteria

Participants must have measurable disease as defined by RECIST v1.1

I have advanced gastric cancer or related types without prior systemic treatment.

My cancer has a PD-L1 level of 1 or higher.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have untreated brain metastases.

I haven't had major heart issues or uncontrolled high blood pressure in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pumitamig in combination with chemotherapy or Nivolumab in combination with chemotherapy

Up to 33 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 47 months

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab
• Pumitamig

Trial Overview The study tests the safety and effectiveness of Pumitamig with chemotherapy (Folfox or Capox) against Nivolumab with the same chemotherapies in patients with certain types of stomach and esophageal cancers.

How Is the Trial Designed?

Group I: Arm D Experimental Treatment 3 Interventions

Group II: Arm C Experimental Treatment 3 Interventions

Group III: Arm B Experimental Treatment 2 Interventions

Group IV: Arm A2 Experimental Treatment 2 Interventions

Group V: Arm A1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

BioNTech SE

Industry Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11583461/

Efficacy and safety of Nivolumab in advanced gastric and ... Nivolumab, both alone and in combination with chemotherapy, improves OS and PFS in patients with advanced gastric and gastroesophageal junction cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01601

3-Year Follow-Up of the Phase III CheckMate 649 Trial At 12.1-month minimum follow-up, nivolumab plus chemotherapy demonstrated improvement in all efficacy measures, including superior overall ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949819824000335

Safety and efficacy of first-line nivolumab plus ... In a 4-year follow-up of the CheckMate 649 trial, the 2- and 4-year OS rates were 28% and 13%, respectively, suggesting that the remarkable response of ...

4. esmoopen.com esmoopen.com/article/S2059-7029(24)01878-7/fulltext

the phase II FRACTION gastric cancer study Grade 3/4 treatment-related adverse events were reported in 22%, 5%, and 18% of patients receiving nivolumab + ipilimumab, nivolumab + ...

5. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/stomach-cancer-immunotherapy-nivolumab

Nivolumab Effective for Advanced Stomach Cancer - NCI In the new study, the combination of nivolumab plus chemotherapy improved overall survival by several months and increased the length of time ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13066-z

The real-world efficacy and safety of nivolumab plus ... Our results demonstrated an ORR of 55.6%, which aligns closely with the 60% ORR reported in the nivolumab plus chemotherapy group of the ...