Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Iowa
About this trial
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.
Eligibility criteria
Qualifiers
Capable of understanding and complying with the protocol requirements and have signed the informed consent document. Patients with mild cognitive impairment may be considered for enrollment in the study if their legally authorized representative provides written informed consent for the patient.
18 years or older in age
Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, 2017, amendable to en block surgical resection as determined by colorectal surgeon.
Biopsy specimen for diagnosis of dMMR Colon cancer should have enough tissue for minimum 4 and max 6 adjacent unstained FFPE slides (4µm each) as determined by Protocol Pathologist Dr. Anthony Snow for CD3+ and CD8+ analysis. If there is not enough tissue present in original sample, a repeat colonoscopy and biopsy may be performed; otherwise patient is not eligible.
Disqualifiers
ECOG performance status less than or equal to 1
Absence of metastatic disease on CT CAP with Contrast within 28 days from treatment start
Absolute neutrophil count greater than or equal to 1,500/µL
Platelets greater than or equal to 100,000/µL
Trial design
Treatments tested in this trial
- Dostarlimab
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
2University of Iowa Hospitals & Clinics52242, Iowa CityIowa, United States
University of Wisconsin53792, MadisonWisconsin, United States
Sponsors and collaborators
University of Iowa
Lead sponsor
Source ClinicalTrials.gov