A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2031-04-15

Brief Summary

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The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.

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Detailed Description

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Conditions

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Neoplasms, Rectal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dostarlimab monotherapy

Participants will receive dostarlimab as monotherapy.

Group Type EXPERIMENTAL

Dostarlimab

Intervention Type BIOLOGICAL

Dostarlimab will be administered.

Interventions

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Dostarlimab

Dostarlimab will be administered.

Intervention Type BIOLOGICAL

Other Intervention Names

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GSK4057190A TSR-042

Eligibility Criteria

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Inclusion Criteria

* Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma
* Participant has radiologically and endoscopically evaluable disease
* Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment

Exclusion Criteria

* Participant has distant metastatic disease
* Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer
* Has a known additional malignancy that progressed or required active treatment within the past 2 years
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3, immune-related severe neurologic events of any-grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade \[SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic symptoms)\], or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary
* Has any history of interstitial lung disease or pneumonitis
* Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant)
* Has a history of severe allergic and/or anaphylactic reactions to chimeric, human, or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No