154 Participants Needed

Dostarlimab for Rectal Cancer

(AZUR-1 Trial)

Recruiting at 62 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

In a clinical trial, dostarlimab showed a 100% remission rate in patients with mismatch repair-deficient rectal cancer, meaning all patients experienced a complete response without needing surgery, chemotherapy, or radiotherapy.12346

Who Is on the Research Team?

GC

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

My rectal cancer is advanced but hasn't spread far (Stage II to III).
My tumor is identified as mismatch repair deficient or has high microsatellite instability.
Participant has radiologically and endoscopically evaluable disease

Exclusion Criteria

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.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dostarlimab monotherapy to achieve complete clinical response

Up to 33 weeks

Non-operative Management (NOM)

Participants undergo close surveillance for recurrent disease after achieving complete clinical response

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 74 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dostarlimab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Dostarlimab monotherapyExperimental Treatment1 Intervention

Dostarlimab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Jemperli for:
🇺🇸
Approved in United States as Jemperli for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

Dostarlimab (JEMPERLI) is a PD-1 monoclonal antibody that has received rapid FDA approval for treating adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, showing promising tumor response rates.
A clinical trial (NCT04165772) reported a remarkable 100% remission rate for rectal cancer patients treated with Dostarlimab, highlighting the potential of matching tumor genetics with targeted therapies, and the trial is ongoing for other cancer types like gastric, prostate, and pancreatic cancers.
Dostarlimab: A Review.Costa, B., Vale, N.[2022]
Dostarlimab is a monoclonal antibody that targets the PD-1 receptor and has been approved for treating adult patients with mismatch repair deficient recurrent or advanced endometrial cancer based on promising results from the GARNET trial.
The approval of dostarlimab in the EU and USA marks a significant milestone in cancer treatment, highlighting its potential efficacy in targeting specific cancer types.
Dostarlimab: First Approval.Markham, A.[2021]
Dostarlimab-gxly (Jemperli) has received accelerated approval from the FDA for treating adults with mismatch repair deficient recurrent or advanced endometrial cancer and solid tumors, indicating its potential effectiveness in these specific cancer types.
This approval highlights the importance of targeted therapies in oncology, particularly for patients with specific genetic markers that may influence treatment outcomes.
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors.Aschenbrenner, DS.[2023]

Citations

Dostarlimab: A Review. [2022]
Dostarlimab: First Approval. [2021]
New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. [2023]
Defying all odds in MMR-deficient rectal cancers. [2022]
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer. [2022]
Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security