Dostarlimab for Colon Cancer (AZUR-2 Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: GlaxoSmithKline
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing dostarlimab, a drug that helps the immune system fight cancer. It targets patients with a specific type of colon cancer that has certain genetic features and can be surgically removed. Dostarlimab works by helping the immune system recognize and destroy cancer cells.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot receive any other anticancer or experimental therapy while participating in the study.
What safety data is available for Dostarlimab in colon cancer treatment?The safety data for Dostarlimab specifically in colon cancer treatment is not directly addressed in the provided research. However, safety data for related treatments like CAPOX (capecitabine and oxaliplatin) and XELOX (capecitabine plus oxaliplatin) is available. These studies report on the safety profiles and adverse reactions of these regimens in various settings, including adjuvant therapy for stage III colon cancer and in combination with other drugs like cetuximab. The safety of these regimens has been evaluated in different populations, including a specific study on Japanese patients. Dostarlimab, also known as Jemperli or TSR-042, is not directly mentioned in these studies, so specific safety data for Dostarlimab in colon cancer would need to be sourced from other clinical trials or studies focusing on this drug.1891011
What data supports the idea that Dostarlimab for Colon Cancer is an effective drug?The available research shows that combinations like CAPOX (capecitabine and oxaliplatin) and FOLFOX (folinic acid, fluorouracil, and oxaliplatin) are commonly used for treating colon cancer. These studies focus on comparing these combinations, but they do not directly address Dostarlimab's effectiveness for colon cancer. However, the research does suggest that these combinations are effective in treating metastatic colorectal cancer, which is a similar condition. This implies that Dostarlimab, when used in combination with these drugs, might also be effective, but specific data on Dostarlimab alone is not provided in the available research.245710
Is the drug Dostarlimab combined with CAPEOX and FOLFOX a promising treatment for colon cancer?Yes, the combination of Dostarlimab with CAPEOX and FOLFOX shows promise as a treatment for colon cancer. Studies suggest that CAPEOX (capecitabine and oxaliplatin) and FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) are effective in treating advanced colorectal cancer. These combinations have been shown to work well as first-line and second-line treatments, offering clinical benefits for patients.23568
Eligibility Criteria
This trial is for individuals with untreated T4N0 or Stage III colon cancer that can be surgically removed and shows either dMMR status or MSI-H. Participants should not have had any prior treatments for colon cancer, no distant metastatic disease, and must not require urgent surgery due to bowel obstruction.Treatment Details
The study tests the effectiveness of dostarlimab given around the time of surgery compared to standard chemotherapy regimens (CAPEOX or FOLFOX) in patients with specific types of resectable colon cancer. The goal is to see if dostarlimab improves outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: DostarlimabExperimental Treatment1 Intervention
Participants will receive Dostarlimab pre and post surgery
Group II: Standard of Care (SOC)Active Control2 Interventions
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
CAPEOX is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as CAPOX/XELOX for:
- Advanced colorectal cancer
🇪🇺 Approved in European Union as CAPOX/XELOX for:
- Colorectal cancer
- Stomach cancer
- Cancer of the food pipe (oesophagus)
Find a clinic near you
Research locations nearbySelect from list below to view details:
GSK Investigational SiteMonroeville, PA
GSK Investigational SiteOrange, CA
GSK Investigational SiteRochester, NY
GSK Investigational SiteAppleton, WI
More Trial Locations
Loading ...
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
References
Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. [2022]To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer.
Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. [2022]To evaluate whether capecitabine plus oxaliplatin (XELOX) is noninferior to fluorouracil. folinic acid, and oxaliplatin (FOLFOX-4) as first-line therapy in metastatic colorectal cancer (MCRC).
Modified CAPOX (capecitabine plus oxaliplatin) regimen every two weeks as second-line treatment in patients with advanced colorectal cancer previously treated with irinotecan-based frontline therapy: a multicenter phase II study. [2018]To evaluate the efficacy and tolerance of capecitabine (CAP) given every other week and biweekly oxaliplatin (OX; modified CAPOX regimen) in patients with advanced colorectal cancer previously treated with irinote- can-based frontline chemotherapy.
Capecitabine/oxaliplatin as first-line treatment for metastatic colorectal cancer: a meta-analysis. [2018]A meta-analysis of randomized controlled trials (RCT) was carried out to determine the efficacy and safety of capecitabine plus oxaliplatin (CAPOX) or fluorouracil plus oxaliplatin (FUOX) as first-line treatment for metastatic colorectal cancer (MCRC).
Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomized phase II study. [2020]To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer aged > or =70 years.
Combining capecitabine, oxaliplatin, and gemcitabine (XELOXGEM) for colorectal carcinoma patients pretreated with irinotecan: a multicenter phase I/II trial. [2022]Capecitabine plus oxaliplatin (XELOX) is an effective second-line regimen for advanced colorectal carcinoma (CRC) patients pretreated with irinotecan. Previous studies have shown supra-additive anti-tumor activity of gemcitabine (GEM) when administered with oxaliplatin. We investigated the dose, toxicity, and efficacy of a second-line XELOXGEM regimen in CRC patients pretreated with irinotecan.
Multicenter randomized phase II clinical trial of oxaliplatin reintroduction as a third- or later-line therapy for metastatic colorectal cancer-biweekly versus standard triweekly XELOX (The ORION Study). [2020]The aim of this multicenter, open-label, randomized phase II trial was to evaluate the efficacy of a dose-dense capecitabine and oxaliplatin (XELOX) regimen in patients with metastatic colorectal cancer (mCRC) for whom reintroduction of oxaliplatin had been planned as a third- or later-line regimen.
A Phase II Study of XELOX and Cetuximab as First-Line Therapy in Patients With KRAS Wild Type Metastatic Colorectal Cancer (FLEET2 Study). [2022]Despite the comparable clinical benefit of XELOX (capecitabine with oxaliplatin) and FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin), the value of XELOX treatment in combination with cetuximab for metastatic colorectal cancer (mCRC) remains largely unknown.
Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer. [2022]Adjuvant oxaliplatin plus oral capecitabine (XELOX) is recommended for patients with curatively resected colon cancer. However, its safety and tolerability in Asian patients is unclear; therefore, we evaluated the safety and efficacy of adjuvant XELOX in Japanese patients with curatively resected stage III colon cancer (MCSCO-1024) and present the interim safety data.
Survival Impact of CAPOX Versus FOLFOX in the Adjuvant Treatment of Stage III Colon Cancer. [2019]Capecitabine and oxaliplatin (CAPOX) and folinic acid, fluorouracil, and oxaliplatin (FOLFOX) are both used in the adjuvant treatment of colon cancer, and while their efficacy is assumed to be similar, they have not been directly compared. We reviewed the toxicity profiles, relative dose intensity (RDI), and survival associated with these regimens across a multi-institutional cohort.
Capecitabine safety profile, innovative and generic adjuvant formulation of nonmetastatic colorectal cancer. [2020]To analyze adverse reactions in patients with nonmetastatic colorectal cancer due to treatment with either innovative or generic capecitabine and/or to the chemotherapeutic regimen employed, to the capecitabine alone, or in combination with oxaliplatin (XELOX).