Colon Cancer Stage IIIPhase 2SuperheroNCT06830239
Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
A Phase 2 study testing Dostarlimab in people with Colon Cancer Stage III, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Stage III
- 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
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Apr 2025to Dec 2028
- 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
- at least 18 years of age and capable of giving informed consent
- primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III
- tumour expresses an MMR proficient/microsatellite stable called MSS
- tissue samples from tumour and colon mucosa available for molecular analyses
- capable of receiving immunotherapy
- adequate general health status and organ function (blood tests)
Who cannot join
- no prior cancer treatment
- not pregnant and using effective contraception if applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. This investigational medicinal product (IMP) has been approved by the Belgian authorities, but not for the treatment of colon cancer.
It is known that a small number of patients with pMMR/MSS colon cancer may have significant response to medication of this type (immunotherapy) depending on each person's biology.
Read more
Trial intervention for all patients will be neo-adjuvant dostarlimab 500 mg IV, given alone by intravenous infusion. Two administrations of dostarlimab are foreseen, at three weeks interval, before surgery for your colon cancer. It has not yet been proven that this treatment can cure, improve or stabilise your disease or condition.
The study aims to investigate specific molecular changes in tumour and blood after dostarlimab monotherapy administered and before surgery which could be associated with improved response to conventional treatment in some patients. If you decide to participate, as the duration of treatment with dostarlimab is 6 weeks, surgery may be slightly delayed compared to patients that are not treated with dostarlimab and go directly for surgery. It remains uncertain if this is beneficial in your personal situation but some patients might experience significant response. The risks have been carefully assessed and the potential benefits for some patients are considered important and justify undertaking the treatment.
Subsequent therapy after surgery remains at the discretion of the treating physician.
The duration of a patient on trial will last up to 4 months from the first dose of dostarlimab and afterwards 2 years of follow up is applicable.
- Conditions
- Colon Cancer Stage III
- Being tested
- Dostarlimab
- Keywords
- Colon Cancer, Neoadjuvant, pMMR/MSS, Resectable
- 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 Jemperli
Dostarlimab [Jemperli GlaxoSmithKline (GSK)] is a humanized IgG4 monoclonal antibody that binds with high affinity and specificity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.
Dostarlimab is in clinical development for the treatment of subjects with solid tumors, including those with recurrent/advanced dMMR/MSI-H solid tumors who have progressed on standard of care chemotherapy, as monotherapy or in combination with other agents.
| Study group | Role | What they receive |
|---|---|---|
| Dostarlimab monotherapy | Experimental | Dostarlimab should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes at a dose of 500 mg once every 3 weeks (Q3W), for 2 cycles (6 weeks in total). Receives: Drug: Dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-omic exploration
Data generation through multi-omic exploration of blood and tissue derived products (see Sampling and Lab manual). Correlation of molecular-biological features identified with pathological response. The presence or absence of specific molecular characteristics in blood and tissue will be correlated in each patient with the degree of tumour response to therapy evaluated by a pathologist.
Measured: From enrollment to the last FU visit of the patient for blood (2 years). From baseline to surgery for tissue (12-15 weeks). Data will be reported at the final study report (max 3 years from study start).
Secondary outcomes (3)
Safety analysis
Safety analysis. Frequency and severity of treatment emergent AEs, SAEs, irAEs. AEs leading to death, discontinuation of trial intervention or resulting in the participant not being suitable for surgery.
Measured: Continuous
Pathological response
Proportion of participants with pathological response, determined by local assessment.
Measured: Pathological tumor staging and response assessment is at surgery
Survival
Survival time defined from Superhero ICF signature to death from any cause. Proportion of survivors at 2 years.
Event free survival time (EFS) defined from Superhero ICF signature to recurrence evaluated by local assessment or death.
Measured: From enrollment till last FU visit of patient (2 years). Data will be reported at the final study report (max 3 years from study start).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Apr 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Tejpar, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830239
- Sponsor's protocol ID
- S68882
- Other IDs
- 2024-512499-36-00
- Acronym
- Superhero
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
- ClinicalTrials.gov ID
- NCT06830239
- Acronym / sponsor ID
- Superhero / S68882
- Conditions
- Colon Cancer Stage III
- Keywords
- Colon Cancer, Neoadjuvant, pMMR/MSS, Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Feb 2025 (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.
Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. This investigational medicinal product (IMP) has been approved by the Belgian authorities, but not for the treatment of colon cancer.
It is known that a small number of patients with pMMR/MSS colon cancer may have significant response to medication of this type (immunotherapy) depending on each person's biology.
Trial intervention for all patients will be neo-adjuvant dostarlimab 500 mg IV, given alone by intravenous infusion. Two administrations of dostarlimab are foreseen, at three weeks interval, before surgery for your colon cancer. It has not yet been proven that this treatment can cure, improve or stabilise your disease or condition.
The study aims to investigate specific molecular changes in tumour and blood after dostarlimab monotherapy administered and before surgery which could be associated with improved response to conventional treatment in some patients. If you decide to participate, as the duration of treatment with dostarlimab is 6 weeks, surgery may be slightly delayed compared to patients that are not treated with dostarlimab and go directly for surgery. It remains uncertain if this is beneficial in your personal situation but some patients might experience significant response. The risks have been carefully assessed and the potential benefits for some patients are considered important and justify undertaking the treatment.
Subsequent therapy after surgery remains at the discretion of the treating physician.
The duration of a patient on trial will last up to 4 months from the first dose of dostarlimab and afterwards 2 years of follow up is applicable.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dostarlimab monotherapy | Experimental | Drug: DostarlimabDostarlimab should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes at a dose of 500 mg once every 3 weeks (Q3W), for 2 cycles (6 weeks in total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age and capable of giving informed consent
- primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III
- tumour expresses an MMR proficient/microsatellite stable called MSS
- tissue samples from tumour and colon mucosa available for molecular analyses
- capable of receiving immunotherapy
Key exclusion criteria (2 listed)
- no prior cancer treatment
- not pregnant and using effective contraception if applicable
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: JemperliDostarlimab [Jemperli GlaxoSmithKline (GSK)] is a humanized IgG4 monoclonal antibody that binds with high affinity and specificity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. Dostarlimab is in clinical development for the treatment of subjects with solid tumors, including those with recurrent/advanced dMMR/MSI-H solid tumors who have progressed on standard of care chemotherapy, as monotherapy or in combination with other agents. | Drug | Dostarlimab monotherapy |
Primary outcome
Multi-omic exploration
Time frame: From enrollment to the last FU visit of the patient for blood (2 years). From baseline to surgery for tissue (12-15 weeks). Data will be reported at the final study report (max 3 years from study start).
Data generation through multi-omic exploration of blood and tissue derived products (see Sampling and Lab manual). Correlation of molecular-biological features identified with pathological response. The presence or absence of specific molecular characteristics in blood and tissue will be correlated in each patient with the degree of tumour response to therapy evaluated by a pathologist.
3 secondary outcomes
Safety analysis
Time frame: Continuous
Pathological response
Time frame: Pathological tumor staging and response assessment is at surgery
Survival
Time frame: From enrollment till last FU visit of patient (2 years). Data will be reported at the final study report (max 3 years from study start).
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 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Colon Cancer Stage III
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
RecruitingPhase 3
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer (CRC)
Not yet recruitingPhase 2
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
Colon Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2/3
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Stage III Colon Cancer
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.
Sabine Tejpar, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site 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 Stage III, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 inclusion and 2 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Sabine Tejpar, MD (+32 16 34 42 25, sabine.tejpar@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-omic exploration (time frame: From enrollment to the last FU visit of the patient for blood (2 years). From baseline to surgery for tissue (12-15 weeks). Data will be reported at the final study report (max 3 years from study start).). 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 Feb 2026.