Novel Treatments for Stomach Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AstraZeneca
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.
Is the drug AZD2936, FOLFOX, MEDI5752, XELOX a promising treatment for stomach cancer?Yes, the drug AZD2936, FOLFOX, MEDI5752, XELOX shows promise for treating stomach cancer. MEDI5752, which targets two immune checkpoints, has shown positive results in early trials. XELOX, a combination of capecitabine and oxaliplatin, has been effective in treating advanced gastric cancer. These treatments are part of ongoing research to improve outcomes for stomach cancer patients.478910
What safety data exists for the treatment options mentioned?The safety data for the treatment options mentioned includes studies on XELOX (capecitabine and oxaliplatin) in advanced gastric cancer. Several studies have evaluated the safety and efficacy of XELOX, either alone or in combination with other drugs like cetuximab. These studies have assessed toxicity, maximum tolerated dose, and overall safety profiles in patients with advanced or recurrent gastric cancer. Comparisons have also been made between XELOX and FOLFOX regimens in terms of safety and efficacy.34567
What data supports the idea that Novel Treatments for Stomach Cancer is an effective treatment?The available research shows that several treatments, like FOLFOX and XELOX, are effective for advanced stomach cancer. For example, a study on FOLFOX-6 showed it works well as a first treatment for advanced or recurring stomach cancer. Another study compared XELOX to FOLFOX and found both to be effective, with XELOX being a good option. Additionally, MEDI5752, which targets specific immune checkpoints, showed promising results in early trials, working well across different types of tumors. These studies suggest that these treatments can be effective options for stomach cancer.124710
Do I have to stop taking my current medications?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on steroids or other immunosuppressive treatments for autoimmune or inflammatory disorders, you may not be eligible to participate.
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.Treatment Details
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.
6Treatment groups
Experimental Treatment
Group I: Substudy 6Experimental Treatment4 Interventions
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
Group II: Substudy 5Experimental Treatment3 Interventions
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group III: Substudy 4Experimental Treatment4 Interventions
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
Group IV: Substudy 3Experimental Treatment4 Interventions
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Group V: Substudy 2Experimental Treatment3 Interventions
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group VI: Substudy 1Experimental Treatment3 Interventions
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research SitePort Jefferson Station, NY
Research SiteNew York, NY
Research SiteBaton Rouge, LA
Research SiteGrand Rapids, MI
More Trial Locations
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Who is running the clinical trial?
AstraZenecaLead Sponsor
References
A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer. [2022]To evaluate the efficacy and toxicity of an oxaliplatin, fluorouracil (5-FU), and folinic acid (FOLFOX-6) combination therapy in patients with advanced or recurrent gastric cancer.
Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group. [2018]This phase II trial assessed the tolerability and efficacy of a triplet of oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer.
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]We evaluated the efficacy and safety of cetuximab in combination with XELOX [XELoda® (capecitabine) and OXaliplatin] in advanced gastric cancer (AGC) patients. The objectives were to evaluate overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety of cetuximab plus XELOX.
[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. [2020]To evaluate the efficacy and toxicity of the combined therapy with oxaliplatin and capecitabine (XELOX) in patients with advanced or recurrent gastric cancer.
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]The purpose of this study was to evaluate the combination of panitumumab and irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy (oxaliplatin, fluoropyrimidines-irinotecan and bevacizumab).
Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. [2022]We evaluated the maximum tolerated dose (MTD) and safety of sunitinib plus capecitabine/cisplatin (XP) or capecitabine/oxaliplatin (XELOX) in Korean patients with advanced gastric cancer (GC).
Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials. [2022]The study aims to compare the efficacy and safety of capecitabine plus oxaliplatin (XELOX) with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in patients with advanced gastric cancer.
Immune Checkpoint Inhibition in Gastro-Oesophageal Cancer. [2019]Recently some progress has been made in the palliative treatment of gastric cancer. It was shown that second-line chemotherapy and VEGF-R2-directed treatment can prolong survival. Despite these advances most patients with metastatic gastric cancer live for less than 2 years. Immune-checkpoint blockade with anti-CTLA4, anti-PD-1 and anti-PD-L1 antibodies has revolutionised the treatment of many cancers. Significant benefit was also proven in gastric adenocarcinomas. Nivolumab improves overall survival as third-line treatment in Asian gastric cancer patients and is already registered in Japan. Pembrolizumab shows significant efficacy, especially in PD-L1-positive patients as third-line treatment and is FDA approved for this indication. Trials with avelumab are promising and studies with atezolizumab and durvalumab are also on the way. To extend the subgroup of benefitting patients combinations of PD-1/PD-L1 antibodies with CTLA4, or VEGF-R2 antibodies or combination with chemotherapy are investigated and show promising results. In this article, the existing evidence of PD1 and PD-L1 blockade as monotherapy or in combination with anti-CTLA4, anti-VEGF-R2 and chemotherapy in gastro-oesophageal adenocarcinoma is reviewed and put into perspective.
Clinical complete response after nivolumab administered as a third-line treatment for unresectable advanced gastric cancer with peritoneal dissemination: A case report. [2021]Nivolumab, which is a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, has been recommended as a third-line treatment based on the results of the ATTRACTION-2 study involving patients with unresectable advanced gastric cancer.
MEDI5752 Suppresses Two Immune Checkpoints. [2022]Preliminary data from a phase I trial of MEDI5752, a bispecific antibody targeting both PD-1 and CTLA4, indicate the drug is well tolerated and active, with durable responses seen across diverse tumor types.