Last updated: 03/14/2025 06:50:32
A Study of Dostarlimab in Participants with Untreated Locally Advanced Rectal Cancer in ChinaChina AZUR-1
GSK study ID
221972
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
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 in China
Trial description: The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.
Primary purpose:
Treatment
Trial design:
Single Group
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 approximately 77 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 37 Weeks
Objective Response Rate (ORR) as assessed by Investigator
Timeframe: Up to 37 Weeks
Organ Preservation Rate
Timeframe: Up to 3 years
Disease-Specific Survival (DSS)
Timeframe: Up to approximately 77 months
Disease-Specific Response at 5 years (DSS5)
Timeframe: Up to 5 years
Overall Survival (OS)
Timeframe: Up to approximately 77 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) and AEs leading to death or discontinuation of study intervention.
Timeframe: Up to approximately 77 months
Serum concentration of Dostarlimab
Timeframe: Up to approximately 77 months
Concentration at the end of infusion (C-EOI) of Dostarlimab
Timeframe: Up to approximately 77 months
Trough Concentration (C-trough) of Dostarlimab
Timeframe: Up to approximately 77 months
Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab
Timeframe: Up to approximately 77 months
Interventions:
Enrollment:
23
Primary completion date:
2027-24-10
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)
October 2024 to April 2031
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 adenocarcinoma
- 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 radiologically and endoscopically evaluable disease
- Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment
Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma
Exclusion criteria:
- Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer
- Has a known additional malignancy that progressed or required active treatment within the past 2 years
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has experienced any of the following with prior immunotherapy: any irAE ≥ 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 [SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
- Has any history of interstitial lung disease or pneumonitis
- Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant)
- Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients
Participant has distant metastatic disease
Trial location(s)
Showing 1 - 6 of 8 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website