This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery. Scans and endoscopy tests will be conducted to see if the tumor disappears and how long the cancer stays under control. The study will also collect information on side effects and health outcomes after dostarlimab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Dostarlimab will be administered.
Percentage of participants who achieve clinical complete response (cCR) amongst participants who receive > 9 cycles (> 6 months) of dostarlimab monotherapy by investigator assessment
Time frame: Up to 168 weeks
Overall cCR rate by investigator assessment
Overall cCR rate is defined as the percentage of participants achieving cCR by investigator assessment at any disease assessment, regardless of duration of dostarlimab therapy among all enrolled participants.
Time frame: Up to 171 weeks
Number of participants with sustained clinical complete response at 12 months (cCR12) as assessed by investigator
cCR12 is defined as achievement and maintenance of cCR for 12 months from the disease assessment after the last dose of study intervention that first demonstrates cCR by investigator assessment.
Time frame: Up to 171 weeks
Objective response rate (ORR) as assessed by investigator
ORR is defined as the percentage of participants who achieve a best clinical response of partial response (PR), near complete response (nCR), or clinical complete response (cCR) at any disease assessment.
Time frame: Up to 171 weeks
Number of participants with composite cCR12 and pathologic complete response (pCR) as assessed by investigator
The composite endpoint of cCR12 and pCR is defined as the number of participants who either achieve cCR12, or achieve pCR after receiving dostarlimab (before receiving standard of care)
Time frame: Up to 171 weeks
Time to cCR
Time to cCR is defined as the time from the first dose of study intervention to the time of first cCR as assessed by the investigator.
Time frame: Up to 171 weeks
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), immune-mediated adverse event (imAEs), and AEs leading to death or discontinuation of study intervention by severity
Time frame: Up to 171 weeks
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