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Chemotherapy
Dostarlimab for Colon Cancer (AZUR-2 Trial)
Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
AZUR-2 Trial Summary
This trial tests a new drug to see if it can help treat colon cancer in people with a certain gene defect.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Dostarlimab may cause allergic reactions, immune-related issues like inflammation in organs, fatigue, digestive problems, skin reactions, and could potentially worsen pre-existing conditions such as lung disease.
AZUR-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Event-free Survival (EFS) assessed by local assessment
Number of Participants with AEs and SAEs by Severity
Number of Participants with Anti-Drug Antibodies against Dostarlimab
+6 moreSide effects data
From 2022 Phase 2 trial • 18 Patients • NCT0440900280%
Anemia
80%
Fatigue
73%
Abdominal pain
67%
CD4 lymphocytes decreased
67%
Alkaline phosphatase increased
67%
Nausea
60%
Anorexia
60%
Constipation
53%
Platelet count decreased
53%
Hyperglycemia
47%
Thromboembolic event
47%
Weight loss
47%
Anxiety
47%
Hypoalbuminemia
40%
Vomiting
40%
Peripheral motor neuropathy
40%
Blood bilirubin increased
40%
Dyspnea
40%
Hypertension
33%
Edema limbs
33%
Abdominal distension
33%
Aortic valve disease
33%
Back pain
33%
Diarrhea
33%
Fever
33%
Hypocalcemia
33%
Sinus tachycardia
27%
Depression
27%
White blood cell decreased
27%
Chills
27%
Ascites
27%
Hyponatremia
20%
Pain
20%
Urine discoloration
20%
Paresthesia
20%
Sore throat
20%
Delirium
20%
Cough
20%
Dizziness
20%
Lymphocyte count decreased
13%
Insomnia
13%
Palpitations
13%
Thrush
13%
Pain in extremity
13%
Neutrophil count decreased
13%
Confusion
13%
Dehydration
13%
Fall
13%
Cardiac troponin T increased
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Bloating
13%
Dry mouth
13%
Dysphagia
13%
Dysuria
13%
Flatulence
13%
Gastroesophageal reflux disease
13%
Glucosuria
13%
Hiccups
13%
Hypercalcemia
13%
Hyperkalemia
13%
Hypokalemia
13%
Hypophosphatemia
13%
Hypothyroidism
13%
Localized edema
7%
Skin ulceration
7%
Oral pain
7%
Obesity
7%
Oral hemorrhage
7%
Encephalopathy
7%
Generalized muscle weakness
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Osteoporosis
7%
Urinary retention
7%
Papulopustular rash
7%
Skin infection
7%
Endocarditis infective
7%
Erectile dysfunction
7%
Hematuria
7%
Stroke
7%
Thyroid stimulating hormone increased
7%
Hemorrhoidal hemorrhage
7%
Urinary frequency
7%
Superficial thrombophlebitis
7%
Tremor
7%
Eye disorders - Other, specify
7%
Pelvic pain
7%
Prostatic obstruction
7%
Pruritus
7%
Rash acneiform
7%
Rectal pain
7%
Renal calculi
7%
Reproductive system and breast disorders - Other, specify
7%
Wheezing
7%
Portal vein thrombosis
7%
Vaginal dryness
7%
Alopecia
7%
Arthralgia
7%
Arthritis
7%
Bacteremia
7%
Biliary tract infection
7%
Blood lactate dehydrogenase increased
7%
Buttock pain
7%
Dry skin
7%
Dysgeusia
7%
Flank pain
7%
Gastric anastomotic leak
7%
Gastric ulcer
7%
Gastritis
7%
Gastrointestinal disorders - Other, specify
7%
Gastrointestinal pain
7%
Hyperlipidemia
7%
Hypoglycemia
7%
Lethargy
7%
Memory impairment
7%
Mucositis oral
7%
Muscle cramp
7%
Muscle weakness lower limb
7%
Myocarditis
7%
Restlessness
7%
Scleral disorder
7%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niraparib+Dostarlimab + Radiation
AZUR-2 Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dostarlimab
2020
Completed Phase 2
~1000
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,105 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or serious injuries in the last 28 days.My cancer has spread to distant parts of my body.My tumor is causing severe bowel problems needing urgent surgery.I have an untreated colon cancer diagnosis.My tumor is identified as dMMR or MSI-H.I have a history of lung inflammation or scarring.I have had a stem cell or organ transplant.I have severe allergies to certain antibodies or components in cancer treatments.My colon cancer is at an advanced stage but can still be surgically removed.I am not on any other cancer treatments or experimental drugs.I have had treatment (like chemo, immunotherapy, or surgery) for colon cancer.I have liver problems, including cirrhosis or unstable liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Dostarlimab
- Group 2: Standard of Care (SOC)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical investigation for prospective participants?
"Data hosted on clinicaltrials.gov reflects that this trial is presently seeking out participants. It was initially posted online on August 1st 2023 and the details were most recently revised two weeks later, on August 21st 2023."
Answered by AI
Does the Food and Drug Administration recognize Dostarlimab as a safe treatment?
"As this is a Phase 3 trial, with evidence of efficacy and multiple rounds of safety data collected, Dostarlimab was rated as safe with a score of 3."
Answered by AI
In how many health care centers is this clinical experiment conducted?
"This medical investigation is taking place in 159 sites, with concentrations of locations found in Leuven, Liège and Roeselare. It would be prudent for enrollees to choose a local centre so that the travelling requirements are kept at bay."
Answered by AI
How many individuals have been recruited to participate in this trial thus far?
"Affirmative. According to information available on clinicaltrials.gov, this medicinal exploration was initially made public on August 1st 2023 and has been recently amended on the 21st of that same month. Currently, 711 participants are required for the study which is being conducted across 159 various venues."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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