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NCT Number: NCT06640049

A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neoplasms, Rectal Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Chengdu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 a tumor which can be categorized as dMMR or MSI-H by central assessment

Exclusion criteria

  • Participant has distant metastatic disease
  • 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

Treatment and study plan

Dostarlimab

Biological

Dostarlimab will be administered.

Other names: GSK4057190A, TSR-042

Primary outcomes

  1. 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 Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.

Secondary outcomes

  1. 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 cCR as assessed by ICR for 24 months following their first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months.

  2. 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 cCR as assessed by ICR for 36 months following first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months.

  3. 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 from the first dose of study intervention as assessed by Investigator.

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

    Time frame: Up to approximately 77 months

    EFS is defined as time from the date of first dose of study intervention to any of the following events including progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause.

  5. Number of Participants with cCR12 as assessed by Investigator

    Time frame: 18 Months

    cCR12 is achieved when a participant maintains cCR as assessed by Investigator for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.

  6. Number of Participants with cCR24 as assessed by Investigator

    Time frame: 30 Months

    cCR24 is achieved when a participant maintains cCR as assessed by Investigator for 24 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 24 months of assessment time, amounting to a total of 30 months.

  7. Number of Participants with cCR36 as assessed by Investigator

    Time frame: 42 Months

    cCR36 is achieved when a participant maintains cCR as assessed by Investigator for 36 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 36 months of assessment time, amounting to a total of 42 months.

  8. Objective Response Rate (ORR) assessed by ICR

    Time frame: Up to 37 Weeks

    ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or cCR at post-intervention disease assessment (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.

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

    Time frame: Up to 37 Weeks

    ORR by Investigator is defined as number of participants achieving a PR, nCR, or cCR at PIDA.

  10. Organ Preservation Rate

    Time frame: Up to 3 years

    Organ Preservation Rate is defined as number of participants who did not undergo any rectal cancer surgery either as primary management or for local recurrence, or who did not have a permanent colostomy created, at any time up to 3 years.

  11. Disease-Specific Survival (DSS)

    Time frame: Up to approximately 77 months

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

  12. 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.

  13. Overall Survival (OS)

    Time frame: Up to approximately 77 months

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

  14. Overall Survival at 5 years (OS5)

    Time frame: Up to 5 years

    OS5 is defined as number of participants being alive at 5 years from first dose of study intervention.

  15. 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.

    Time frame: Up to approximately 77 months

  16. Serum concentration of Dostarlimab

    Time frame: Up to approximately 77 months

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

    Time frame: Up to approximately 77 months

  18. Trough Concentration (C-trough) of Dostarlimab

    Time frame: Up to approximately 77 months

  19. Number of Participants with Anti-Drug Antibodies (ADA) against Dostarlimab

    Time frame: Up to approximately 77 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: China AZUR-1

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Oct 15, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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