AzTrials
AzTrials

Neoplasms, RectalPhase 2AZUR-1NCT05723562

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

A Phase 2 study testing Dostarlimab in people with Neoplasms, Rectal, run by GlaxoSmithKline at 42 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Rectal
What is being tested?
Dostarlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
42 sitesin 10 countries
Study dates
3 Apr 2023to 11 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

42 sites in 10 countries.

42 sites in 10 countries

United States7 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Dallas, Texas, 75390

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New York, New York, 10022

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • GSK Investigational Site

    Richmond, Virginia, 23298

Other trials in United States

Spain6 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

France5 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Marseille, 13273

  • GSK Investigational Site

    Paris, 75012

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Rennes, 35000

Other trials in France

Germany5 sites

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Dresden, 01307

  • GSK Investigational Site

    Düsseldorf, 40225

  • GSK Investigational Site

    Frankfurt, 60488

  • GSK Investigational Site

    München, 81377

Other trials in Germany

Canada4 sites

  • GSK Investigational Site

    Montreal, Quebec, H2X 0C1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Japan4 sites

  • GSK Investigational Site

    Chiba, 277-8577

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Osaka, 540-0006

  • GSK Investigational Site

    Osaka, 565-0871

Other trials in Japan

South Korea4 sites

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-710

Other trials in South Korea

Italy3 sites

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Padova, 35128

  • GSK Investigational Site

    Roma, 00168

Other trials in Italy

United Kingdom3 sites

  • GSK Investigational Site

    Leeds West Yorkshire, LS9 7TF

  • GSK Investigational Site

    London, EC1A 7BE

  • GSK Investigational Site

    Sutton, SM2 5PT

Other trials in United Kingdom

Netherlands1 site

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Dostarlimab
Keywords
JEMPERLI, dostarlimab-gxly, GSK4057190, Stage II/III rectal cancer, Neoadjuvant, dMMR, MSI-H
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DostarlimabBiological

    Also called JEMPERLI, dostarlimab-gxly, TSR-042, GSK4057190

    Dostarlimab will be administered.

Study groups in NCT05723562
Study groupRoleWhat they receive
Dostarlimab monotherapyExperimentalNot described
Receives: Biological: Dostarlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)

    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)

    Measured: 18 Months

Secondary outcomes (20)

  1. Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR

    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)

    Measured: 30 Months

  2. Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR

    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)

    Measured: 42 Months

  3. Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator

    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

    Measured: 3 years

  4. Event Free Survival (EFS) as assessed by Investigator

    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

    Measured: Up to 74 months

  5. Number of Participants with cCR12 as assessed by Investigator

    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)

    Measured: 18 Months

  6. Number of Participants with cCR24 as assessed by Investigator

    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)

    Measured: 30 Months

  7. Number of Participants with cCR36 as assessed by Investigator

    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)

    Measured: 42 Months

  8. Objective Response Rate (ORR) assessed by ICR

    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

    Measured: Up to 33 Weeks

  9. Objective Response Rate (ORR) as assessed by Investigator

    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

    Measured: Up to 33 Weeks

  10. Organ Preservation Rate

    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

    Measured: 3 years

  11. Disease-Specific Survival (DSS)

    DSS is defined as time from the date of first dose of study intervention to death due to disease

    Measured: Up to 74 months

  12. Disease-Specific Response at 5 years (DSS5)

    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

    Measured: Up to 5 years

  13. Overall Survival (OS)

    OS is defined as time from first dose of study intervention to death from any cause

    Measured: Up to 74 months

  14. Overall Survival at 5 years (OS5)

    OS is defined as number of participants as being alive at 5 years from first dose of study intervention

    Measured: Up to 5 years

  15. Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune mediated Adverse Events (imAEs) based on Severity

    Measured: Up to 74 months

  16. Number of Participants with discontinuation of study intervention

    Measured: Up to 24 weeks

  17. Serum concentration of Dostarlimab

    Measured: Up to 37 weeks

  18. Concentration at the end of infusion (C-EOI) of Dostarlimab

    Measured: Up to 37 weeks

  19. Trough Concentration (C-trough) of Dostarlimab

    Measured: Up to 37 weeks

  20. Number of Participants with Anti-Drug Antibodies against Dostarlimab

    Measured: Up to 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start3 Apr 2023
  3. Primary completion2 Nov 2026 (estimated)
  4. Study completion11 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723562
Sponsor's protocol ID
219369
Other IDs
2022-003289-18
Acronym
AZUR-1
Status last verified
May 2026
First submitted
2 Feb 2023
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Cercek A, Bachet JB, Folprecht G, Bando H, Seligmann J, Starling N, Riesco-Martinez MC, Alfonso PG, Smith D, Salvatore L, Flores EG, Mitry E, Chen E, Castillon JC, Morano F, Keranen SR, Aubin F, Lopez CL, Lonardi S, Buchschacher G Jr, Roderburg C, Gerlinger M, Modest D, Heinemann V, Goetze TO, Kato T, Park YS, Perkins G, Lemay F, Vickers M, Szijgyarto Z, Stjepanovic N, Haftchenary S, Diaz LA Jnr, Roodhart JML. Clinical Complete Response with Dostarlimab Monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer: First Results from the Global AZUR-1 Trial. Ann Oncol. 2026 Oct 25:S0923-7534(26)08070-1. doi: 10.1016/j.annonc.2026.10.1280. Online ahead of print.

    PubMed 42927858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dostarlimab in people with Neoplasms, Rectal, run by GlaxoSmithKline at 42 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, France, Germany, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) (time frame: 18 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723562, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in