Dostarlimab for Rectal Cancer
(AZUR-1 Trial)

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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.

+5 more

Participant Groups

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.

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:

Mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen

🇺🇸 Approved in United States as Jemperli for:

Adults with dMMR recurrent or advanced solid tumors who have progressed on or following prior treatment and lack satisfactory alternative treatment options
Primary advanced or recurrent dMMR endometrial cancer in combination with carboplatin and paclitaxel