Study on Pembrolizumab and Porustobart Before Surgery for Treating Resectable Colon Cancer
Sponsor: Solstice Oncology, Inc.
ClinicalTrials ID:NCT07808151
This clinical trial is testing if two medicines, porustobart and pembrolizumab, given before surgery can effectively treat a type of colon cancer called microsatellite stable (MSS) colon cancer. The study aims to find out how well these medicines work together to shrink the cancer and what side effects they might cause.
Patient Parameters
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Program Overview
The purpose of this study is to determine if using two medicines, porustobart and pembrolizumab, before surgery can help treat a type of colon cancer known as microsatellite stable (MSS) colon cancer. This cancer can be surgically removed and has not spread to other parts of the body. Both medicines are designed to boost the immune system's ability to fight cancer. The study will compare two groups to see which treatment schedule is more effective and safer. Both groups will receive pembrolizumab, but one group will get one dose of porustobart, while the other group will receive two doses. Participants will undergo tests to confirm eligibility, receive the medicines through a vein, have surgery 6-9 weeks after starting treatment, and return for follow-up checkups every 6 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a diagnosis of colon cancer that is microsatellite stable (MSS) and can be surgically removed.
- Have a specific stage of cancer (T3 or T4) that has not spread to other parts of the body (M0).
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Provide a sufficient tumor tissue sample for analysis.
- Have adequate blood, liver, and kidney function.
- Follow reproductive and contraception guidelines as per the study protocol.
Exclusion Criteria
- Have taken an investigational drug within 3 weeks before the first dose of the study medicines.
- Have an urgent need for surgery.
- Have previously been treated with certain immune checkpoint inhibitors.
- Be on systemic corticosteroid or immunosuppressive therapy within 1 week before the first dose, with some exceptions.
- Have a history of severe allergic reactions to fully human monoclonal antibodies, lung disease, or pneumonitis requiring steroids.
- Have an active or past autoimmune disease that required systemic treatment within the last 2 years.
- Have had major surgery within 4 weeks before the first dose or have an active infection requiring treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Investigator Site | 90033 | Los Angeles | California |
| Investigator Site | 33612 | Tampa | Florida |
| Investigator Site | 60637 | Chicago | Illinois |
| Investigator Site | 21287 | Baltimore | Maryland |
| Investigator Site | 02114 | Boston | Massachusetts |
| Investigator Site | 10016 | New York | New York |
| Investigator Site | 10021 | New York | New York |
| Investigator Site | 10027 | New York | New York |
| Investigator Site | 44106 | Cleveland | Ohio |
| Investigator Site | 37232 | Nashville | Tennessee |
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