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

NCT06640049 | Active Not Recruiting Phase 2

• 1 other identifier: 221972
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Neoplasms, Rectal

Keywords

Dostarlimab; GSK4057190A; TSR-042; Rectal cancer; dMMR; MSI-H

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR)

  cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Independent central review (ICR) for 12 months from the first disease assessment after last dose of study intervention. Timeframe calculation includes 6 months (9 cycles of dostarlimab, with each cycle lasting 21 days) plus an additional 12 months of assessment time, amounting to a total of 18 months.

  18 months

Secondary Outcomes (19)

• Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR

  30 months

• Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR

  42 months

• Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator

  3 years

• Event Free Survival (EFS) as assessed by Investigator

  Up to approximately 77 months

• Number of Participants with cCR12 as assessed by Investigator

  18 Months

Study Arms (1)

Dostarlimab monotherapy

EXPERIMENTAL

Participants will receive dostarlimab as monotherapy.

Biological: Dostarlimab

Interventions

Dostarlimab BIOLOGICAL

Dostarlimab will be administered.

Also known as: GSK4057190A, TSR-042

Dostarlimab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

Chengdu, 610041, China

Location

GSK Investigational Site

Chongqing, 400010, China

Location

GSK Investigational Site

Guangzhou, 510060, China

Location

GSK Investigational Site

Guangzhou, 510655, China

Location

GSK Investigational Site

Hangzhou, 310016, China

Location

GSK Investigational Site

Hangzhou, China

Location

GSK Investigational Site

Jinan, 250117, China

Location

GSK Investigational Site

Kunming, 650106, China

Location

GSK Investigational Site

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

dostarlimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 24, 2027
• Study Completion (Estimated): April 15, 2031
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CN (9)