Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT05239546
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Participants will receive Dostarlimab 500 mg IV every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for 8 cycles until 1.5 years

Study Details

This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.

Key Dates

Start date
Mar 24, 2023
Status verified
May 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Dostarlimab
    Participants will receive Dostarlimab 500 mg IV every 3 weeks for 6 cycles followed by 1000 mg every 6 weeks for 8 cycles until 1.5 years

Primary Outcome Measure

Major Clinical Response (MCR) Rate [ Time Frame: From Dostarlimab initiation to 18 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & ClinicsIowa CityIowa52242
Saima Sharif
[email protected]
319-353-8155
Alisha Demsky
[email protected]
319-384-5461

Find similar trials in Iowa City, IA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Iowa Hospitals & Clinics· Iowa City, IA

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