A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
AZUR-1
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
2 other identifiers
interventional
154
10 countries
42
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Longer than P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 11, 2029
January 8, 2026
January 1, 2026
3.6 years
February 2, 2023
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
18 Months
Secondary Outcomes (20)
Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
30 Months
Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
42 Months
Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
3 years
Event Free Survival (EFS) as assessed by Investigator
Up to 74 months
Number of Participants with cCR12 as assessed by Investigator
18 Months
- +15 more secondary outcomes
Study Arms (1)
Dostarlimab monotherapy
EXPERIMENTALInterventions
Dostarlimab will be administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131, United States
GSK Investigational Site
New York, New York, 10022, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Dallas, Texas, 75390, United States
GSK Investigational Site
Richmond, Virginia, 23298, United States
GSK Investigational Site
Ottawa, Ontario, K1H 8L6, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Montreal, Quebec, H2X 0C1, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Marseille, 13273, France
GSK Investigational Site
Paris, 75012, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Rennes, 35000, France
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Dresden, 01307, Germany
GSK Investigational Site
Düsseldorf, 40225, Germany
GSK Investigational Site
Frankfurt, 60488, Germany
GSK Investigational Site
München, 81377, Germany
GSK Investigational Site
Milan, 20133, Italy
GSK Investigational Site
Padua, 35128, Italy
GSK Investigational Site
Roma, 00168, Italy
GSK Investigational Site
Chiba, 277-8577, Japan
GSK Investigational Site
Kanagawa, 232-0024, Japan
GSK Investigational Site
Osaka, 540-0006, Japan
GSK Investigational Site
Osaka, 565-0871, Japan
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
GSK Investigational Site
Seoul, 05505, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 135-710, South Korea
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Santander, 39008, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF, United Kingdom
GSK Investigational Site
London, EC1A 7BE, United Kingdom
GSK Investigational Site
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2023
First Posted
February 10, 2023
Study Start
April 3, 2023
Primary Completion (Estimated)
November 2, 2026
Study Completion (Estimated)
October 11, 2029
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.