Last updated: 08/06/2025 08:50:16
A Real-world Study to Evaluate Clinical Outcomes of dostarlimab in Participants with Previously Untreated Stage II/III DNA mismatch repair-deficient (dMMR)/ Microsatellite instability-high (MSI-H) Locally Advanced Rectal Cancer
GSK study ID
223011
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: A Real-world Study to Evaluate Clinical Outcomes of dostarlimab in Patients with Previously Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
Trial description: This is a non-interventional study with an aim to describe the characteristics of participants with stage II/III dMMR/MSI-H locally advanced rectal cancer and evaluate the clinical outcomes of dostarlimab treatment in this participant population.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants who maintain real-world complete clinical response (rw-cCR) for 12 months
Timeframe: Index date (first disease response assessment following end of dostarlimab treatment) up to 12 months
Percentage of participants who maintain complete clinical and pathological response combined for 12 months
Timeframe: Index date (first disease response assessment following end of dostarlimab treatment) up to 12 months
Secondary outcomes:
Percentage of participants with real-world best overall response (rwBOR)
Timeframe: Up to approximately 3 years
Percentage of participants with real-world pathological complete response (rw-pCR)
Timeframe: Up to approximately 3 years
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2028-15-12
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)
March 2025 to December 2028
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Diagnosis of stage II or stage III rectal cancer on or after 01 June 2022
- Adults age greater than or equal to (≥)18 years
- Evidence of stage IV rectal cancer on or prior to the overall index date
- Evidence of malignancy or 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
Inclusion and exclusion criteria
Inclusion criteria:
- Adults age greater than or equal to (≥)18 years
- Initiated dostarlimab therapy as part of the Compassionate use program (CUP)
- Lab results indicating dMMR status or MSI-H phenotype
Diagnosis of stage II or stage III rectal cancer on or after 01 June 2022
Exclusion criteria:
- Evidence of malignancy or 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
Evidence of stage IV rectal cancer on or prior to the overall index date
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
Recruitment complete
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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