Last updated: 08/04/2025 17:30:09
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal CancerAZUR-1
GSK study ID
219369
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)
Timeframe: 18 Months
Secondary outcomes:
Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR
Timeframe: 30 Months
Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR
Timeframe: 42 Months
Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator
Timeframe: 3 years
Event Free Survival (EFS) as assessed by Investigator
Timeframe: Up to 74 months
Number of Participants with cCR12 as assessed by Investigator
Timeframe: 18 Months
Number of Participants with cCR24 as assessed by Investigator
Timeframe: 30 Months
Number of Participants with cCR36 as assessed by Investigator
Timeframe: 42 Months
Objective Response Rate (ORR) assessed by ICR
Timeframe: Up to 33 Weeks
Objective Response Rate (ORR) as assessed by Investigator
Timeframe: Up to 33 Weeks
Organ Preservation Rate
Timeframe: 3 years
Disease-Specific Survival (DSS)
Timeframe: Up to 74 months
Disease-Specific Response at 5 years (DSS5)
Timeframe: Up to 5 years
Overall Survival (OS)
Timeframe: Up to 74 months
Overall Survival at 5 years (OS5)
Timeframe: Up to 5 years
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) based on Severity
Timeframe: Up to 74 months
Number of Participants with discontinuation of study intervention
Timeframe: Up to 24 weeks
Serum concentration of Dostarlimab
Timeframe: Up to 37 weeks
Concentration at the end of infusion (C-EOI) of Dostarlimab
Timeframe: Up to 37 weeks
Trough Concentration (C-trough) of Dostarlimab
Timeframe: Up to 37 weeks
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Timeframe: Up to 37 weeks
Interventions:
Enrollment:
154
Primary completion date:
2026-02-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Rectal
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
April 2023 to October 2029
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 distant metastatic disease.
- Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer.
Inclusion and exclusion criteria
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 irAE 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 location(s)
Location
GSK Investigational Site
Albuquerque, NM, United States, 87131
Status
Recruitment Complete
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Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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