Novel Treatments for Stomach Cancer

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: HER2-positive, CNS metastases, Autoimmune disorders, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing new combinations of drugs to treat advanced stomach cancer that can't be removed by surgery or has spread. Researchers want to see if these drug combinations are effective and safe, and how the body handles them. A group of patients will participate to find the best dose.

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.

What data supports the effectiveness of the drug AZD2936, FOLFOX, FOLFOX4, FOLFOX6, FOLFOX7, MEDI5752, Volrustomig, MEDI-5752, PD-1/CTLA-4 bispecific mAb, PD-l/CTLA-4 DuetMab, XELOX, Capecitabine/Oxaliplatin for stomach cancer?

Research shows that combinations like FOLFOX and XELOX, which include drugs like oxaliplatin and capecitabine, are effective in treating advanced gastric (stomach) cancer. Additionally, MEDI5752, which targets immune checkpoints, has shown promising results in various tumors, suggesting potential benefits for stomach cancer as well. ^{1 2 3 4 5}

Is the XELOX treatment generally safe for humans?

The XELOX treatment, which combines capecitabine and oxaliplatin, has been studied for safety in patients with advanced gastric cancer. These studies suggest that XELOX is generally safe, but like all treatments, it can have side effects, which should be discussed with a healthcare provider. ^{3 5 6 7 8}

What makes the drug AZD2936, FOLFOX, MEDI5752, XELOX unique for stomach cancer treatment?

This treatment is unique because it combines traditional chemotherapy (FOLFOX and XELOX) with MEDI5752, a novel bispecific antibody that targets two immune checkpoints, PD-1 and CTLA4, potentially enhancing the immune system's ability to fight cancer. This combination aims to improve outcomes by leveraging both chemotherapy and advanced immunotherapy. ^{3 4 5 9 10}

Research Team

Eligibility Criteria

Adults over 18 with a body weight above 35 kg, diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread, and who haven't been treated for it yet. Participants should have a life expectancy of at least 12 weeks and good performance status (able to carry out daily activities). Those with active infections, previous immune-oncology treatments, certain HER2-positive cancers, uncontrolled brain metastases, serious illnesses, another cancer history or uncontrollable ascites are excluded.

Inclusion Criteria

Has measurable target disease assessed by the Investigator based on RECIST 1.1

Life expectancy of at least 12 weeks

I am 18 years old or older.

Exclusion Criteria

My stomach cancer is HER2 positive or uncertain but not negative.

I have been treated with immunotherapy before.

I do not have any uncontrolled illnesses.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel combination therapies, including Rilvegostomig, AZD0901, volrustomig, XELOX, FOLFOX, and AZD7789, depending on the substudy

Average of 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival

Average of 2 years

Treatment Details

Interventions

• AZD2936 (Other)
• FOLFOX (Anti-metabolites)
• MEDI5752 (Monoclonal Antibodies)
• XELOX (Anti-metabolites)

Trial Overview The trial is testing new combinations of drugs including chemotherapy agents like 5-Fluorouracil and Capecitabine as well as novel therapies AZD0901, Rilvegostomig, FOLFOX regimen components and Volrustomig. It aims to evaluate how effective these combinations are in treating the cancer while also monitoring safety profiles and how the body processes the drugs.

Participant Groups

Group I: Substudy 6 Experimental Treatment 4 Interventions

AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine

Group II: Substudy 5 Experimental Treatment 3 Interventions

AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Group III: Substudy 4 Experimental Treatment 4 Interventions

AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine

Group IV: Substudy 3 Experimental Treatment 4 Interventions

AZD0901 plus volrustomig and 5-fluorouracil or capecitabine

Group V: Substudy 2 Experimental Treatment 3 Interventions

Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Group VI: Substudy 1 Experimental Treatment 3 Interventions

Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Port Jefferson Station, NY

Research Site Baton Rouge, LA

Research Site Grand Rapids, MI

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group. Comella, P., Lorusso, V., Maiorino, L., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer. Luo, HY., Xu, RH., Zhang, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials. Xu, HB., Huang, F., Su, R., et al.[2022]

The phase I trial of MEDI5752, a bispecific antibody that targets both PD-1 and CTLA4, shows that the drug is well tolerated by patients.

Preliminary results indicate that MEDI5752 is active in treating various tumor types, with durable responses observed, suggesting potential effectiveness in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEDI5752 Suppresses Two Immune Checkpoints. [2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. Min, N., He, BF., Zhang, LS., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. Lee, KW., Park, SR., Oh, DY., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer. Kim, C., Lee, JL., Ryu, MH., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. André, T., Blons, H., Mabro, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical complete response after nivolumab administered as a third-line treatment for unresectable advanced gastric cancer with peritoneal dissemination: A case report. Komo, T., Suzuki, T., Tazawa, H., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Checkpoint Inhibition in Gastro-Oesophageal Cancer. Smyth, E., Thuss-Patience, PC.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

MEDI5752 Suppresses Two Immune Checkpoints. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical complete response after nivolumab administered as a third-line treatment for unresectable advanced gastric cancer with peritoneal dissemination: A case report. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Immune Checkpoint Inhibition in Gastro-Oesophageal Cancer. [2019]