Your session is about to expire
← Back to Search
Monoclonal Antibodies
Dostarlimab for Rectal Cancer (AZUR-1 Trial)
Phase 2
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 5 years
Awards & highlights
AZUR-1 Trial Summary
This trial tests if dostarlimab can help treat rectal cancer without chemo, radiation, or surgery, aiming to find if it leads to a complete response.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests Dostarlimab as a solo therapy on patients with specific types of advanced rectal cancer. The aim is to see if this drug alone can effectively treat the cancer without needing chemotherapy, radiation, or surgery. Patients who respond completely will be monitored closely instead of undergoing traditional treatments.See study design
What are the potential side effects?
Dostarlimab may cause immune-related side effects such as inflammation in various organs including the lungs (pneumonitis), skin reactions like rashes and potentially more serious conditions like Stevens-Johnson Syndrome/toxic epidermal necrolysis/DRESS syndrome; neurological issues; blood disorders; fatigue; allergic reactions; and increased risk of infections.
AZUR-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
Secondary outcome measures
Concentration at the end of infusion (C-EOI) of Dostarlimab
Disease-Specific Response at 5 years (DSS5)
Disease-Specific Survival (DSS)
+17 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-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Dostarlimab monotherapyExperimental Treatment1 Intervention
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
8,070,685 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My rectal cancer is advanced but hasn't spread far (Stage II to III).I have another cancer besides the one being studied, but it hasn't needed treatment in the last 2 years, except for certain skin, bladder cancers, or cancers that haven't spread.I have an autoimmune disease treated with medication in the last 2 years.I have had or plan to have a transplant with donor stem cells.My tumor is identified as mismatch repair deficient or has high microsatellite instability.My cancer has spread to distant parts of my body.I have had treatment for rectal cancer before.I've had severe side effects from previous immunotherapy.I have a history of lung scarring or inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Dostarlimab monotherapy
Awards:
This trial has 1 awards, including:- 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.
Has the FDA given its stamp of approval to Dostarlimab as a standalone treatment?
"As Dostarlimab monotherapy is currently in the second phase of clinical trials, our team at Power scored it a 2 on safety. While there is evidence for its security, no efficacy data has yet been collected."
Answered by AI
Are any openings available for volunteer participants in this clinical trial?
"Clinicaltrials.gov reveals that this investigation, which was first listed on April 3rd 2023, still requires participants and has been recently refreshed as of August 11th 2023."
Answered by AI
How many participants are receiving treatment through this trial?
"That is correct. The clinicaltrials.gov page reveals that this trial, which was first uploaded on April 3rd 2023, is actively recruiting patients. 150 participants are needed from 54 different healthcare facilities."
Answered by AI
How many venues are presently hosting this clinical trial?
"As of now, 54 clinics across Los Angeles, Sacramento and Whittier as well as other cities are running this trial. To alleviate the burden of travel, it is beneficial to select a clinic close by should you choose to take part in the research."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’m looking for new treatment since I’m stage 4.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- GSK Investigational Site: < 48 hours
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger