A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1)

May 21, 2026 updated by: GlaxoSmithKline

A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
  • France
      • Besançon, France, 25030
        • GSK Investigational Site
      • Marseille, France, 13273
        • GSK Investigational Site
      • Paris, France, 75012
        • GSK Investigational Site
      • Pessac, France, 33604
        • GSK Investigational Site
      • Rennes, France, 35000
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Dresden, Germany, 01307
        • GSK Investigational Site
      • Düsseldorf, Germany, 40225
        • GSK Investigational Site
      • Frankfurt, Germany, 60488
        • GSK Investigational Site
      • München, Germany, 81377
        • GSK Investigational Site
  • Italy
      • Milan, Italy, 20133
        • GSK Investigational Site
      • Padova, Italy, 35128
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
  • Japan
      • Chiba, Japan, 277-8577
        • GSK Investigational Site
      • Kanagawa, Japan, 232-0024
        • GSK Investigational Site
      • Osaka, Japan, 540-0006
        • GSK Investigational Site
      • Osaka, Japan, 565-0871
        • GSK Investigational Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • GSK Investigational Site
  • South Korea
      • Seoul, South Korea, 06591
        • GSK Investigational Site
      • Seoul, South Korea, 05505
        • GSK Investigational Site
      • Seoul, South Korea, 120-752
        • GSK Investigational Site
      • Seoul, South Korea, 135-710
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Granada, Spain, 18014
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site
  • United Kingdom
      • Leeds West Yorkshire, United Kingdom, LS9 7TF
        • GSK Investigational Site
      • London, United Kingdom, EC1A 7BE
        • GSK Investigational Site
      • Sutton, United Kingdom, SM2 5PT
        • GSK Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10022
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer
  • Participant has radiologically and endoscopically evaluable disease.
  • Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Exclusion Criteria:

  • Participant has distant metastatic disease.
  • Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.
  • Participant has any history of interstitial lung disease or pneumonitis
  • Participant has experienced any of the following with prior immunotherapy: any imAE of Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary.
  • Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers.
  • Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients.
  • Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dostarlimab monotherapy
Biological: Dostarlimab
Dostarlimab will be administered.
Other Names:
  • TSR-042
  • GSK4057190
  • JEMPERLI
  • dostarlimab-gxly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
Time Frame: 18 Months
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 12 months following their post-intervention disease assessment (PIDA)
18 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with discontinuation of study intervention
Time Frame: Up to 24 weeks
Up to 24 weeks
Serum concentration of Dostarlimab
Time Frame: Up to 37 weeks
Up to 37 weeks
Concentration at the end of infusion (C-EOI) of Dostarlimab
Time Frame: Up to 37 weeks
Up to 37 weeks
Trough Concentration (C-trough) of Dostarlimab
Time Frame: Up to 37 weeks
Up to 37 weeks
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Time Frame: Up to 37 weeks
Up to 37 weeks
Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
Time Frame: 30 Months
cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 24 months following their post-Intervention disease assessment (PIDA)
30 Months
Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
Time Frame: 42 Months
cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 36 months following their post-Intervention disease assessment (PIDA)
42 Months
Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
Time Frame: 3 years
EFS3 is defined as participants who remained alive and free of disease progression precluding surgery, local recurrence, and distant recurrence at 3 years as assessed by Investigator
3 years
Event Free Survival (EFS) as assessed by Investigator
Time Frame: Up to 74 months
EFS is defined as time from the date of first dose of study intervention to any of the following events: progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause
Up to 74 months
Number of Participants with cCR12 as assessed by Investigator
Time Frame: 18 Months
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 12 months following their post-intervention disease assessment (PIDA)
18 Months
Number of Participants with cCR24 as assessed by Investigator
Time Frame: 30 Months
cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 24 months following their post-intervention disease assessment (PIDA)
30 Months
Number of Participants with cCR36 as assessed by Investigator
Time Frame: 42 Months
cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 36 months following their post-intervention disease assessment (PIDA)
42 Months
Objective Response Rate (ORR) assessed by ICR
Time Frame: Up to 33 Weeks
ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or complete clinical response (cCR) at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or incomplete clinical response (iCR) (PIDA 2) as assessed by ICR
Up to 33 Weeks
Objective Response Rate (ORR) as assessed by Investigator
Time Frame: Up to 33 Weeks
ORR by Investigator, defined as achieving a PR, nCR, or cCR at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or iCR
Up to 33 Weeks
Disease-Specific Survival (DSS)
Time Frame: Up to 74 months
DSS is defined as time from the date of first dose of study intervention to death due to disease
Up to 74 months
Disease-Specific Response at 5 years (DSS5)
Time Frame: Up to 5 years
DSS5 is defined as the number of participants not dying due to disease under study at 5 years from the first dose of study intervention
Up to 5 years
Overall Survival (OS)
Time Frame: Up to 74 months
OS is defined as time from first dose of study intervention to death from any cause
Up to 74 months
Overall Survival at 5 years (OS5)
Time Frame: Up to 5 years
OS is defined as number of participants as being alive at 5 years from first dose of study intervention
Up to 5 years
Organ Preservation Rate
Time Frame: 3 years
Organ Preservation Rate defined as not undergoing Total Mesorectal Excision (TME), either as primary management or for local recurrence, and who did not have a permanent colostomy created, at any time up to 3 years
3 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune mediated Adverse Events (imAEs) based on Severity
Time Frame: Up to 74 months
Up to 74 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 219369
  • 2022-003289-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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