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New treatment option for Colon Cancer
Official title Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers
ClinicalTrials.gov ID: NCT05239546
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colon cancer.
Also referred to as TSR-042.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of understanding and complying with the protocol requirements and have signed the informed consent document. Patients with mild cognitive...
- 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...
- 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...
- Potentially surgically resectable Stage II or III patients who are willing to forgo surgical resection if study endpoints are met. Patient with...
You likely can't join if
- 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...
See the full eligibility 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...
- 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+...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.