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NCT Number: NCT07269249

Real-world Efficacy and Safety of Neoadjuvant Dostarlimab in Patients With dMMR/MSI-H Locally Advanced Rectal Cancer

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.

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Key information

Conditions

Locally Advanced Rectal Cancer (LARC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica, Naples, Italy

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dostarlimab

Drug

Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Primary outcomes

  1. 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.

Secondary outcomes

  1. duration of clinical complete response

    Time frame: up to to 12 months

    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.

  2. near-complete clinical response rate

    Time frame: at 6 and 12 months up to 12 months

    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.

  3. duration of near-complete clinical response

    Time frame: up to 12 months

    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.

  4. rate of surgery (total mesorectal excision or local excision)

    Time frame: at 6 months (at the end of neoadjuvant dostarlimab)

    defined as the proportion of patients who undergo surgical resection of the primary tumor, including either total mesorectal excision (TME) or local excision

  5. pathological complete response rate

    Time frame: after surgery (at 6 months)

    defined as a Tumor Regression Grade (TRG) 1 according to Mandard modified scoring system.

  6. 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

    defined as the percentage of trial participants having a CR or PR, as per RECIST v1.1.

  7. safety of neoadjuvant dostarlimab

    Time frame: at the end of each cycle of dostarlimab (every 21 days ) up to 6 months

    Adverse events/Serious adverse events incidence and grading according to NCI-CTCAE v. 5.0

  8. Event-free survival

    Time frame: up to 12 months

    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.

  9. Time to distant recurrence

    Time frame: up to 12 months

    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.

  10. Overall survival

    Time frame: up to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Carmela Piccirillo, MD

CONTACT

[email protected]

+39 08117770280

Piera Gargiulo, MD

CONTACT

[email protected]

+39 081 1777 0279

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Acronym: RW-NEDOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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