Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
Recruiting
Observational Study
Locally Advanced Rectal Cancer (LARC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
National Cancer Institute, Naples · Other
Who this trial is looking for
This trial is looking for adults with a specific type of rectal cancer who would like to receive a treatment called dostarlimab. Participants will be part of a study to see how well this treatment works and its safety in real-life situations.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have locally advanced rectal cancer diagnosed by a doctor.
I have a certain genetic status called dMMR/MSI-H.
I have signed an informed consent form.
I have received at least one dose of dostarlimab since November 2023.
I am listed in the AIFA dostarlimab monitoring registry for rectal cancer.
You may not be able to join if
I have distant metastasis.
I have major cognitive dysfunction or psychiatric disorders.
I have had any previous treatment for rectal cancer.
I have received dostarlimab as part of another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is an observational, retrospective-prospective, multicentre trial enrolling all patients included in the AIFA monitoring registry of Dostarlimab for the indication in rectal cancer. The aims of the study are to describe the clinical outcomes and safety of patients with dMMR/MSI-H locally advanced rectal cancer (LARC) receiving neoadjuvant dostarlimab in the real-world setting.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Signed informed consent form
* 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 dost…
Inclusion Criteria:
* Signed informed consent form
* 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:
* \- Distant metastasis
* Major cognitive dysfunction or psychiatric disorders
* Any previous systemic or local treatment for rectal cancer
* Dostarlimab received within an interventional clinical trial
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