Locally Advanced Rectal Cancer (LARC)RW-NEDOSNCT07269249
Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
An observational study of Locally Advanced Rectal Cancer (LARC), run by National Cancer Institute, Naples at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Dostarlimab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (any sex/gender) with dMMR/MSI-H locally advanced rectal cancer treated with dostarlimab are eligible for this study.
Who may be able to join
- 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)
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- 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
Who cannot join
- - Distant metastasis
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic or local treatment for rectal cancer
- Dostarlimab received within an interventional clinical trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica
Naples, 80131
Bruno Daniele, MD, 081 1777 0279, bruno.daniele@aslnapoli1centro.it
Bruno Daniele, MD
- Recruiting
IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale
Naples
Antonio Avallone, MD, +39 081177703557, a.avallone@istitutotumori.na.it
Antonio Avallone, MD
About this study
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.
Read the detailed description
The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1).
Secondary objectives are:
- 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.
- 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.
- 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
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Dostarlimab
- Keywords
- dostarlimab, mismatch repair-deficient LARC, real-world, retrospective-prospective study, neoadjuvant setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Dostarlimab 500 mg iv every 3 weeks for 9 cycles
| Study group | Role | What they receive |
|---|---|---|
| Stage II-III rectal cancer (LARC) | patients with dMMR/MSI LARC treated with neoadjuvant dostarlimab Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
Measured: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
Secondary outcomes (10)
duration of clinical complete response
defined as the time from the first documented date of clinical complete response to the date of documented local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first.
Measured: up to to 12 months
near-complete clinical response rate
absence of mass at digital rectal exam, small mucosal irregularity or superficial ulcer no more than 2 cm in diameter at endoscopic exam, and no metastatic nodes at MRI.
Measured: at 6 and 12 months up to 12 months
duration of near-complete clinical response
defined as the time from the first documented date of near-complete clinical response to the date of documented conversion to complete clinical response, local tumor regrowth, disease recurrence, or last available follow-up, whichever occurs first.
Measured: up to 12 months
rate of surgery (total mesorectal excision or local excision)
defined as the proportion of patients who undergo surgical resection of the primary tumor, including either total mesorectal excision (TME) or local excision
Measured: at 6 months (at the end of neoadjuvant dostarlimab)
pathological complete response rate
defined as a Tumor Regression Grade (TRG) 1 according to Mandard modified scoring system.
Measured: after surgery (at 6 months)
objective response rate assessed by central radiological review
defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
Measured: fter 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
safety of neoadjuvant dostarlimab
Adverse events/Serious adverse events incidence and grading according to NCI-CTCAE v. 5.0
Measured: at the end of each cycle of dostarlimab (every 21 days ) up to 6 months
Event-free survival
defined as the time between dostarlimab starting and disease recurrence (local or distant), or disease progression (radiological or clinical) or second primary colorectal malignancy, or death from any cause, whichever comes first.
Measured: up to 12 months
Time to distant recurrence
defined as the time between dostarlimab starting and distant disease recurrence or progression. Patients who do not have a distant recurrence and are alive at the end of the study will be censored at the date of the last assessment visit.
Measured: up to 12 months
Overall survival
defined as the time between dostarlimab starting and death from any cause. Patients alive at the end of the study will be censored at the date of the last follow-up contact.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Carmela Piccirillo, MD, Principal investigator, National Cancer Institute, IRCCS Fondazione G. Pascale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269249
- Sponsor's protocol ID
- RW-NEDOS
- Acronym
- RW-NEDOS
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07269249
- Acronym / sponsor ID
- RW-NEDOS / RW-NEDOS
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- dostarlimab, mismatch repair-deficient LARC, real-world, retrospective-prospective study, neoadjuvant setting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1).
Secondary objectives are:
- 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.
- 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.
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage II-III rectal cancer (LARC) | – | Drug: Dostarlimabpatients with dMMR/MSI LARC treated with neoadjuvant dostarlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (any sex/gender) with dMMR/MSI-H locally advanced rectal cancer treated with dostarlimab are eligible for this study.
Key inclusion criteria (9 listed)
- 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
- 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)
Key exclusion criteria (4 listed)
- - Distant metastasis
- Major cognitive dysfunction or psychiatric disorders
- Any previous systemic or local treatment for rectal cancer
- Dostarlimab received within an interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabDostarlimab 500 mg iv every 3 weeks for 9 cycles | Drug | Stage II-III rectal cancer (LARC) |
Primary outcome
Objective response rate (ORR)
Time frame: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
Defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.
10 secondary outcomes
duration of clinical complete response
Time frame: up to to 12 months
near-complete clinical response rate
Time frame: at 6 and 12 months up to 12 months
duration of near-complete clinical response
Time frame: up to 12 months
rate of surgery (total mesorectal excision or local excision)
Time frame: at 6 months (at the end of neoadjuvant dostarlimab)
pathological complete response rate
Time frame: after surgery (at 6 months)
objective response rate assessed by central radiological review
Time frame: fter 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months
safety of neoadjuvant dostarlimab
Time frame: at the end of each cycle of dostarlimab (every 21 days ) up to 6 months
Event-free survival
Time frame: up to 12 months
Time to distant recurrence
Time frame: up to 12 months
Overall survival
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Yes
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Not yet recruitingPhase 2/3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Carmela Piccirillo, MD principal investigator
National Cancer Institute, IRCCS Fondazione G. Pascale
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer (LARC), run by National Cancer Institute, Naples at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Carmela Piccirillo, MD (+39 08117770280, m.piccirillo@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.