A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Trial Title: A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

NCT ID: NCT05723562

Condition: Neoplasms, Rectal

Conditions: Official terms:
Rectal Neoplasms
Dostarlimab

Conditions: Keywords:
JEMPERLI
dostarlimab-gxly
GSK4057190A
Stage II/III rectal cancer
Neoadjuvant
dMMR
MSI-H

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Dostarlimab
Description: Dostarlimab will be administered.
Arm group label: Dostarlimab monotherapy

Other name: JEMPERLI

Other name: dostarlimab-gxly

Other name: TSR-042

Other name: GSK4057190A

Summary: The purpose of this study is to investigate dostarlimab monotherapy in participants with locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment. Participants who achieve complete clinical response (cCR) following dostarlimab treatment will undergo non-operative management (NOM), including close surveillance for recurrent disease. The goal of the study is to determine if Dostarlimab therapy alone is an effective treatment that can allow participants to avoid chemotherapy, radiation, and surgery.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal cancer - Participant has radiologically and endoscopically evaluable disease. - Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment Exclusion Criteria: - Participant has distant metastatic disease. - Participant has received prior radiation therapy, systemic therapy, or surgery for management of rectal cancer. - Participant has any history of interstitial lung disease or pneumonitis - Participant has experienced any of the following with prior immunotherapy: any irAE of 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 (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically significant laboratory abnormalities are not exclusionary. - Participant has a known additional malignancy that progressed or required active treatment within the past 2 years. Exceptions include adequately treated superficial skin cancers, superficial bladder cancers, and other in situ cancers. - Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. - Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or has known allergies to dostarlimab or its excipients. - Has received or plans to receive an organ or stem cell transplant that uses donor stem cells (allogeneic stem cell transplant).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: GSK Investigational Site

Address:
City: Little Rock
Zip: 72205
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Los Angeles
Zip: 90027
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Sacramento
Zip: 95817
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Whittier
Zip: 90602
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Washington
Zip: 20010
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Atlanta
Zip: 30322
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Chicago
Zip: 60612
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Indianapolis
Zip: 46237
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Baltimore
Zip: 21215
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Kansas City
Zip: 64128
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Saint Louis
Zip: 63110
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Albuquerque
Zip: 87131
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: New York
Zip: 10022
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Sioux Falls
Zip: 57105
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Amarillo
Zip: 79106
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Dallas
Zip: 75390
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Richmond
Zip: 23298
Country: United States

Facility:
Name: GSK Investigational Site

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Montreal
Zip: H2X 0A9
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Sherbrooke
Zip: J1H 5N4
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: BesanCon cedex
Zip: 25030
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Marseille
Zip: 13273
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Paris
Zip: 75012
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Pessac cedex
Zip: 33604
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Rennes
Zip: 35000
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Berlin
Zip: 13353
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Dresden
Zip: 01307
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Duesseldorf
Zip: 40225
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Frankfurt
Zip: 60488
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Muenchen
Zip: 81377
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Chiba
Zip: 277-8577
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Kanagawa
Zip: 232-0024
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Osaka
Zip: 540-0006
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Osaka
Zip: 565-0871
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 135-710
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Utrecht
Zip: 3584 CX
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Granada
Zip: 18014
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Leeds West Yorkshire
Zip: LS9 7TF
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Start date: April 3, 2023

Completion date: October 11, 2029

Lead sponsor:
Agency: GlaxoSmithKline
Agency class: Industry

Source: GlaxoSmithKline

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05723562