Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
NCT ID: NCT07269249
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-09-01
2027-12-31
Brief Summary
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Detailed Description
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Secondary objectives are:
1. To describe the activity of neoadjuvant dostarlimab in terms of:
* complete clinical response rate at 6 and 12 months
* time to clinical complete response
* duration of clinical complete response
* near-complete clinical response rate at 6 and 12 months
* duration of near-complete clinical response
* duration of objective response
* rate of surgery (total mesorectal excision or local excision)
* pathological complete response rate
* objective response rate (RECIST 1.1) assessed by central radiological review.
2. To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0.
3. To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Stage II-III rectal cancer (LARC)
patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab
Dostarlimab
Dostarlimab 500 mg iv every 3 weeks for 9 cycles
Interventions
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Dostarlimab
Dostarlimab 500 mg iv every 3 weeks for 9 cycles
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Histologically confirmed stage II-III rectal cancer
* dMMR/MSI status assessed locally by Immunohistochemistry, next-generation sequencing or PCR
For the retrospective part of the study:
* At least one dose of neoadjuvant dostarlimab from November 2023 (i.e. within the period of AIFA dostarlimab monitoring registry activation for the indication in rectal cancer, which is reimbursed according to the Italian law 648/1996, GU n.252 as of 27/10/2023)
* Eligible deceased or unreachable patients will also be included to avoid selection biases, in respect of the article 110 bis, paragraph 4 of the Italian Privacy Code (a Data Protection Impact Assessment will be produced and published on the Sponsor website before study initiation, and patients explicitly unwilling before death will be not included).
For the prospective part of the study:
\- Inclusion in the AIFA dostarlimab monitoring registry for the indication in rectal cancer, to receive dostarlimab according to the Italian law 648/1996, GU n.252 as of 27/10/2023
Exclusion Criteria
* Major cognitive dysfunction or psychiatric disorders
* Any previous systemic or local treatment for rectal cancer
* Dostarlimab received within an interventional clinical trial
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Maria Carmela Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, IRCCS Fondazione G. Pascale
Locations
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ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica
Napoli, , Italy
IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale
Napoli, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RW-NEDOS
Identifier Type: -
Identifier Source: org_study_id
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