Dostarlimab for Rectal Cancer
(AZUR-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a drug called dostarlimab on patients with a specific type of rectal cancer who haven't been treated before. The goal is to see if this drug alone can treat the cancer effectively, so patients might avoid more aggressive treatments like chemotherapy, radiation, and surgery. Dostarlimab (Jemperli™) has been approved in the EU and USA for treating certain types of cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have an active autoimmune disease that required treatment in the past 2 years, you may not be eligible to participate.
Is dostarlimab safe for humans?
Dostarlimab has been approved by the FDA for certain types of cancer, and in a trial for rectal cancer, it showed promising results with no patients experiencing cancer progression or recurrence. However, as with any medication, there may be side effects, and its safety continues to be evaluated in ongoing trials.12345
What makes the drug dostarlimab unique for treating rectal cancer?
Dostarlimab is unique because it is an immunotherapy drug that targets the PD-1 receptor, and in a clinical trial, it achieved a 100% remission rate in patients with mismatch repair-deficient rectal cancer, allowing them to avoid traditional treatments like chemotherapy, radiotherapy, or surgery.12346
What data supports the effectiveness of the drug dostarlimab for rectal cancer?
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for adults with Stage II to III locally advanced rectal cancer that hasn't spread and hasn't been treated yet. Their tumors must be dMMR or MSI-H. People can't join if they've had prior treatments for their cancer, certain severe reactions to immunotherapy, other recent cancers (except some skin/bladder/in situ cancers), known allergies to dostarlimab or its parts, recent organ transplants, distant metastases, active autoimmune diseases needing treatment in the last 2 years, or lung disease/pneumonitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dostarlimab monotherapy to achieve complete clinical response
Non-operative Management (NOM)
Participants undergo close surveillance for recurrent disease after achieving complete clinical response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dostarlimab
Dostarlimab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School