Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers (NAIO)
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|ClinicalTrials.gov Identifier: NCT05239546|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer DMMR Colorectal Cancer||Drug: Dostarlimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers|
|Estimated Study Start Date :||June 2023|
|Estimated Primary Completion Date :||June 2028|
|Estimated Study Completion Date :||June 2029|
Experimental: Neoadjuvant Dostarlimab
Participants will receive Dostarlimab 500 mg IV every 3 weeks for 3 doses pre-operatively
Neoadjuvant Dostarlimab (500mg IV every 3 weeks x 3 doses prior to surgical resection) in patients with Stage II and III dMMR CC.
Other Name: TSR-042
- Percentage change in viable tumor cells (VTC) [ Time Frame: After 3 cycles (up to 9 weeks) ]To determine rate of Major Pathological Response (MPR) of <10% viable tumor cells (VTC) in Stage II and III Colon resected tumor after 3 cycles of neoadjuvant Dostarlimab, as measured by percent change pre- and post-treatment
- Determine metastatic disease rate (MDR) [ Time Frame: Up to 13 weeks ]To determine rate of development of metastatic colon cancer on neoadjuvant Dostarlimab. MDR is defined as the proportion of patients who develop metastatic disease prior to surgery.
- Determine disease free survival (DFS) [ Time Frame: Up to 3 years ]DFS is defined as the time from treatment initiation to the date of first documentation of disease recurrence or death due to any cause.
- Determine overall response rate (ORR) [ Time Frame: Up to 5 years ]To estimate ORR on neoadjuvant Dostarlimab. ORR is defined as the proportion of patients with RECIST disease response (CR, PR). All patients that do not meet the criteria for an objective response by the analysis cutoff date will be considered non-responders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05239546
|Contact: Saima Sharif, MDfirstname.lastname@example.org|
|Contact: Cena Jones-Bittermanemail@example.com|
|Principal Investigator:||Saima M Sharif, MD||University of Iowa Holden Comprehensive Cancer Center|