Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

NCT ID: NCT06830239

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-12-31

Brief 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. 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.

Conditions

Colon Cancer Stage III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dostarlimab monotherapy

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).

Group Type: EXPERIMENTAL

Dostarlimab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Jemperli

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Tejpar, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

UZLeuven

Leuven, , Belgium

Countries

Belgium

Central Contacts

Sabine Tejpar, MD

Role: CONTACT

sabine.tejpar@uzleuven.be

+32 16 34 42 25

Facility Contacts

Sabine Tejpar, MD

Role: primary

Other Identifiers

2024-512499-36-00

Identifier Type: CTIS

Identifier Source: secondary_id

S68882

Identifier Type: -

Identifier Source: org_study_id