Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests dostarlimab before planned surgery in adults with stage II or III colon cancer that has dMMR, a problem with how cells repair DNA. It looks at how much the cancer responds after 18 weeks of treatment, up to 6 cycles, and whether patients can safely go without surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and able to follow study rules. You must give written consent; a legal representative may consent if you have mild thinking or memory problems.
- Have stage II or III colon cancer with dMMR confirmed by a tissue sample. A surgeon must judge that the cancer can be removed.
- Have enough tissue for the required tests. Another colon exam and tissue sample may be needed.
- Be willing to skip surgery if the study's treatment goals are met. Mild bowel problems controlled with laxatives or stool softeners are allowed.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have a CT scan within 28 days before treatment showing no cancer spread to distant parts of the body.
- Meet the study's blood count, kidney, liver, and blood-clotting test requirements.
- If you can become pregnant, have a negative blood pregnancy test within 72 hours before treatment and use birth control from screening through 180 days after the last dose. Men who can father a child must use birth control from the first dose through 180 days after the last dose. Usual, preferred abstinence is allowed.
Who can't join
- Have more than one primary tumor, a tumor growing into nearby organs or structures (T4b), or another active, serious cancer within the past 2 years.
- Have a tumor causing a blocked or torn bowel that needs urgent surgery, or heavy bleeding that needs urgent blood transfusions or surgery.
- Have an allergy to dostarlimab ingredients, major surgery within 3 weeks, or recent experimental treatment within the study's waiting period.
- Have an uncontrolled illness, such as an active infection or serious heart problem, or mental health or social problems that prevent following study rules. Severe thinking or memory problems also exclude you.
- Have an immune system disease needing whole-body treatment in the past 2 years, a weak immune system, or recent medicines that weaken it. Some hormone replacement treatments are allowed. Organ transplant recipients taking immune-weakening drugs cannot join.
- Have had a severe immune-related side effect from earlier immune therapy, except certain lab changes, or a history of interstitial lung disease, which affects tissue around the lungs.
- Have HIV with an infection linked to a weak immune system in the past year, active hepatitis B needing treatment but not controlled with antiviral drugs, or hepatitis C that has not met the study's treatment and virus-level requirements.
- Have received a live vaccine within 30 days before treatment, or lack enough tumor tissue for the required tests.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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.
Study sites (2)
IA
- University of Iowa Hospitals & Clinics · Iowa City, IA 52242Saima Sharif · Study contact · 319-353-8155 · saima-sharif@uiowa.eduAlisha Demsky · Study contact · 319-384-5461 · alisha-demsky@uiowa.eduMore trials in Iowa City
WI
- University of Wisconsin · Madison, WI 53792Dustin Deming, MD · Study contact · 608-915-0100More trials in Madison