Colon CancerPhase 2NAIONCT05239546
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
A Phase 2 study testing Dostarlimab in people with Colon Cancer and dMMR Colorectal Cancer, run by University of Iowa at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, dMMR Colorectal Cancer
- What is being tested?
- Dostarlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2023to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Potentially surgically resectable Stage II or III patients who are willing to forgo surgical resection if study endpoints are met. Patient with easily manageable bowel changes amenable to laxatives or stool softeners as outpatient per assessment by colorectal surgery are allowed. (See exclusion criteria #2)
- ECOG performance status less than or equal to 1
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- 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
- Hemoglobin greater than or equal to 9 g/dL
- Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL/min using the Cockcroft-Gault equation
- Total bilirubin less than or equal to 1.5 x ULN (less than or equal to 2.0 in patients with known Gilberts syndrome) OR direct bilirubin less than or equal to 1 x ULN
- Aspartate aminotransferase and alanine aminotransferase less than or equal to 3.0 x ULN
- International normalized ratio (INR) or prothrombin time (PT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants
- Participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to taking study treatment and agree to use an adequate method of contraception from screening through 180 days after the last dose of study treatment. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner starting with first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Who cannot join
- Synchronous primary tumor (i.e. more than 1)
- Obstruction or perforation requiring diverting ostomy or immediate resection, or bright red blood per rectum requiring urgent blood transfusion, from their primary tumor.
- Clinical T4b tumors
- Known hypersensitivity to dostarlimab components or excipients.
- Major surgery less than or equal to 3 weeks prior to initiating protocol therapy
- Received investigational therapy less than or equal to 3 months, or within a time interval less than at least 5 half- lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
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- Heavy bleeding from the colon cancer tumors requiring PRBC transfusions that would require palliative surgical resection
- Concurrent, clinically significant, active malignancies within two years of study enrollment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, glucocorticoids, or immunosuppressive drugs). Other than Replacement hormone therapy with thyroxine for hypothyroidism , insulin for T1 diabetes mellitus , or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)
- Diagnosis of immunodeficiency or has received any systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
- History of greater than or equal to Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.
- Patients with known HIV (Human Immunodeficiency Virus) infection on effective retroviral therapy regardless of CD4 count who have had an opportunistic infection within the past 12 months.
- Organ transplant recipients on immunosuppressive medications
- Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy but not on suppressive antiviral therapy prior to initiation of treatment of this protocol are excluded. Also, patients with history of HCV infection that have not completed curative antiviral treatment and the HCV viral load is not below the limit of quantification areexcluded.(e.g. a patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution is eligible.)
- Prior history of interstitial lung disease.
- Received a live vaccine within 30 days of initiating protocol therapy.
- Not enough tissue for confirming dMMR status and CD3+ /CD8+ testing
- 19. Patients with severe cognitive impairment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Saima Sharif, 319-353-8155, saima-sharif@uiowa.edu
Alisha Demsky, 319-384-5461, alisha-demsky@uiowa.edu
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Dustin Deming, MD, 608-915-0100
About this study
Official title: Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers
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.
Read the detailed description
The purpose of this research study is to look at the effects of the immunotherapy drug dostarlimab on dMMR colon cancer tumors and to see if these patients can avoid surgical resection, with the option to go to surgery only if the tumor does not respond.
- Conditions
- Colon Cancer, dMMR Colorectal Cancer
- Being tested
- Dostarlimab
- Keywords
- Colon cancer, dMMR, Deficient mismatch repair colon cancer, MSI-High, MSI-H, Non-operative management, No surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DostarlimabDrug
Also called TSR-042
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 group | Role | What they receive |
|---|---|---|
| Neoadjuvant Dostarlimab | Experimental | 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 Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Dostarlimab initiation to 18 weeks.
Secondary outcomes (3)
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.
Measured: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
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.
Measured: From treatment Dostarlimab until study completion, up to 5 years.
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.
Measured: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start24 Mar 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Sharif, University of Iowa
- Investigators
- Saima M Sharif, MD, MS, Principal investigator, University of Iowa Holden Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239546
- Sponsor's protocol ID
- 202105539
- Acronym
- NAIO
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers
- ClinicalTrials.gov ID
- NCT05239546
- Acronym / sponsor ID
- NAIO / 202105539
- Conditions
- Colon Cancer, dMMR Colorectal Cancer
- Keywords
- Colon cancer, dMMR, Deficient mismatch repair colon cancer, MSI-High, MSI-H, Non-operative management, No surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this research study is to look at the effects of the immunotherapy drug dostarlimab on dMMR colon cancer tumors and to see if these patients can avoid surgical resection, with the option to go to surgery only if the tumor does not respond.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Dostarlimab | Experimental | Drug: DostarlimabParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Potentially surgically resectable Stage II or III patients who are willing to forgo surgical resection if study endpoints are met. Patient with easily manageable bowel changes amenable to laxatives or stool softeners as outpatient per assessment by colorectal surgery are allowed. (See exclusion criteria #2)
Key exclusion criteria (19 listed)
- Synchronous primary tumor (i.e. more than 1)
- Obstruction or perforation requiring diverting ostomy or immediate resection, or bright red blood per rectum requiring urgent blood transfusion, from their primary tumor.
- Clinical T4b tumors
- Known hypersensitivity to dostarlimab components or excipients.
- Major surgery less than or equal to 3 weeks prior to initiating protocol therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DostarlimabAlso: TSR-042Participants 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 | Drug | Neoadjuvant Dostarlimab |
Primary outcome
Major Clinical Response (MCR) Rate
Time frame: From Dostarlimab initiation to 18 weeks.
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.
3 secondary outcomes
Metastasis-Free Survival (MFS) Prior to Surgery
Time frame: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
Progression-Free Survival (PFS)
Time frame: From treatment Dostarlimab until study completion, up to 5 years.
Overall Response Rate (ORR)
Time frame: From Dostarlimab initiation until surgery or Dostarlimab completion, up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saima M Sharif, MD, MS principal investigator
University of Iowa Holden Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dostarlimab in people with Colon Cancer and dMMR Colorectal Cancer, run by University of Iowa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saima Sharif, MD, MS (319-356-1616, saima-sharif@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Clinical Response (MCR) Rate (time frame: From Dostarlimab initiation to 18 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.