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

ConditionLocally Advanced Rectal Cancer (LARC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- 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 population

Patients (any sex/gender) with dMMR/MSI-H locally advanced rectal cancer treated with dostarlimab are eligible for this study.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Dostarlimab

    Drug

    Dostarlimab 500 mg iv every 3 weeks for 9 cycles

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Stage II-III rectal cancer (LARC)1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

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

Time frame
after 3 , 6 and 9 cycles of dostarlimab. Each cycle is 21 days. Up to 6 months

Secondary outcomes

1

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.

Time frame
up to to 12 months
2

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.

Time frame
at 6 and 12 months up to 12 months
3

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.

Time frame
up to 12 months
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute, Naples

Lead sponsor

Source ClinicalTrials.gov
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