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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Dostarlimab
DrugParticipants 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
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant DostarlimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Clinical Response (MCR) Rate
MCR rate is defined as the proportion of patients meeting the following criteria at 18 weeks: 1) ctDNA is stable or declining, 2) a clinically asymptomatic primary tumor, and 3) no metastatic disease.
Time frame
From Dostarlimab initiation to 18 weeks.Secondary outcomes
1
Metastasis-Free Survival (MFS) Prior to Surgery
MFS is defined as the time from treatment initiation to the date of metastasis or death due to any cause, if occurring prior to surgery. Otherwise, patients will be censored at the date of surgery or last radiographic assessment, whichever occurs first.
Time frame
From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.2
Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to the date of first documentation of disease progression (defined as increasing ctDNA, symptomatic primary tumor or metastasis), or death due to any cause. Otherwise, patients will be censored at last radiographic assessment.
Time frame
From treatment Dostarlimab until study completion, up to 5 years.3
Overall Response Rate (ORR)
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.
Time frame
From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov