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Recruiting NCT07269249

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

— Observational Locally Advanced Rectal Cancer (LARC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dostarlimab.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer (LARC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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:

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)

Interventions

  • Drug Dostarlimab
    Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Primary outcome measures

  • Objective response rate (ORR) [Time frame: after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months]
Secondary outcome measures (10)
  • 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]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • ASL Napoli 1, Presidio Ospedaliero Ospedale del mare, Oncologia medica — Naples
  • IRCCS Fondazione G. Pascale, Unità Operativa Complessa Oncologia Addominale — Naples

Identifiers

NCT: NCT07269249 · RW-NEDOS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗