Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dostarlimab.
- Who it may be relevant to
- Registry conditions: Colon Cancer Stage III. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Dostarlimab
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.
Primary outcome measures
- 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).]
Secondary outcome measures (3)
- 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).]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- no prior cancer treatment
- not pregnant and using effective contraception if applicable
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- UZLeuven — Leuven
Identifiers
NCT: NCT06830239 · S68882 · 2024-512499-36-00