Last updated: 11/06/2025 12:50:15

Effectiveness and safety of dostarlimab in participants with locally advanced rectal cancer from a racial and ethnically diverse population in the United States (US)

GSK study ID
223160
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A non-interventional study to characterize real-world effectiveness and safety of dostarlimab in patients with previously untreated stage II/III mismatch repair deficient (dMMR) or high microsatellite instability (MSI-H) locally advanced rectal cancer from a racial and ethnically diverse patient population in the US
Trial description: The purpose of this non-interventional study is to describe the use of dostarlimab in clinical practice and support characterization of the effectiveness and safety of dostarlimab in participants with previously untreated stage II/III deoxyribonucleic acid mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer overall and by race and ethnicity.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Real-world clinical complete response at 12 months (rw-cCR12)

Timeframe: At 12 months

Number of participants with adverse events of interest (AEIs)

Timeframe: Up to 36 months

Secondary outcomes:

Combined rw-cCR12 or real-world pathologic complete response (rw-pCR)

Timeframe: Up to 12 months

Real-world clinical complete response at 24 months (rw-cCR24)

Timeframe: At 24 months

Real-world clinical complete response at 36 months (rw-cCR36)

Timeframe: At 36 months

Organ preservation rate at 3 years

Timeframe: At 3 years

Real-world time to organ preservation failure

Timeframe: Up to 36 months

Real-world event-free survival (rwEFS)

Timeframe: Up to 36 months

Real-world event free survival at 3 years (rwEFS3)

Timeframe: At 3 years

Real-world overall response rate (rwORR)

Timeframe: Up to 3 months following the last dose of dostarlimab treatment

Overall survival (OS)

Timeframe: Up to 36 months

Number of participants with AEIs by severity and seriousness of AEIs

Timeframe: Up to 36 months

Interventions:
Not applicable
Enrollment:
60
Primary completion date:
2029-28-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Rectal
Product
Dostarlimab
Collaborators
Not applicable
Study date(s)
February 2026 to August 2029
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • A new diagnosis of stage II or stage III (T3-T4, N0, or T any, N+) rectal cancer on or after 01 January 2023.
  • Adults age greater than or equal to (>=) 18 years at stage II/III rectal cancer diagnosis date, previously untreated.
  • Evidence of stage IV rectal cancer on or prior to the overall index date.
  • Evidence of malignancy other than rectal cancer, superficial skin cancer (i.e., non-melanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis.
Inclusion and exclusion criteria
Inclusion criteria:

    A new diagnosis of stage II or stage III (T3-T4, N0, or T any, N+) rectal cancer on or after 01 January 2023.

    • Adults age greater than or equal to (>=) 18 years at stage II/III rectal cancer diagnosis date, previously untreated.
    • Initiated dostarlimab therapy on or after 01 April 2023 as part of standard clinical practice for treatment of stage II/III rectal cancer following date of stage II/III rectal cancer diagnosis.
    • Diagnosis of stage II or stage III (T3-T4, N0, or T any, N+) rectal cancer within 4 months prior to the initiation of dostarlimab treatment.
    • Lab results indicating dMMR status or MSI-H phenotype. -For patients to be eligible for this study, it is required that they were dMMR/MSI-H any time prior to, or within 3 months following, the overall index date (i.e., dostarlimab treatment initiation) and prior to any diagnosis of metastatic disease. Being dMMR/MSI-H at any time prior to the overall index date is acceptable, as long as the dMMR/MSI-H status is related to their current rectal cancer diagnosis (i.e., not from a prior cancer). However, anyone who became dMMR/MSI-H only after 3 months following the overall index date or after any diagnosis of metastatic disease is not eligible for the current study.
    • At least 1-day of follow-up after initiating dostarlimab treatment.
Exclusion criteria:

    Evidence of stage IV rectal cancer on or prior to the overall index date.

    • Evidence of malignancy other than rectal cancer, superficial skin cancer (i.e., non-melanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis.
    • Evidence of active treatment for malignancy other than rectal cancer, superficial skin cancer (i.e., non-melanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis.
    • Evidence of initiation of dostarlimab in a clinical trial.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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