A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
Purpose
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.
Condition
- Neoplasms, Rectal
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dostarlimab monotherapy |
|
Recruiting Locations
GSK Investigational Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
GSK Investigational Site
Los Angeles, California 90027
Los Angeles, California 90027
GSK Investigational Site
Sacramento, California 95817
Sacramento, California 95817
GSK Investigational Site
Whittier, California 90602
Whittier, California 90602
GSK Investigational Site
Washington, District of Columbia 20010
Washington, District of Columbia 20010
GSK Investigational Site
Atlanta, Georgia 30322
Atlanta, Georgia 30322
GSK Investigational Site
Chicago, Illinois 60612
Chicago, Illinois 60612
GSK Investigational Site
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
GSK Investigational Site
Iowa City, Iowa 52242-1009
Iowa City, Iowa 52242-1009
GSK Investigational Site
Baltimore, Maryland 21215
Baltimore, Maryland 21215
GSK Investigational Site
Boston, Massachusetts 02215
Boston, Massachusetts 02215
GSK Investigational Site
Detroit, Michigan 48202
Detroit, Michigan 48202
GSK Investigational Site
Kansas City, Missouri 64128
Kansas City, Missouri 64128
GSK Investigational Site
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
GSK Investigational Site
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
GSK Investigational Site
New York, New York 10022
New York, New York 10022
GSK Investigational Site
Greenville, North Carolina 27834
Greenville, North Carolina 27834
GSK Investigational Site
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
GSK Investigational Site
Nashville, Tennessee 37203
Nashville, Tennessee 37203
GSK Investigational Site
Amarillo, Texas 79106
Amarillo, Texas 79106
GSK Investigational Site
Dallas, Texas 75235
Dallas, Texas 75235
GSK Investigational Site
Dallas, Texas 75390
Dallas, Texas 75390
GSK Investigational Site
Richmond, Virginia 23298
Richmond, Virginia 23298
More Details
- NCT ID
- NCT05723562
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline