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Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Sponsor: Solstice Oncology, Inc.
Summary
The goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer. The main questions this study wants to answer: How well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines? Researchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22). Participants will: Complete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery
Official title: A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09-30
Completion Date
2029-09-30
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Administered to: Arm 1, Arm 2
Porustobart
Administered to: Arm 1, Arm 2
Locations (30)
Investigator Site
Los Angeles, California, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Nashville, Tennessee, United States
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Seattle, Washington, United States
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Anderlecht, Belgium
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Bonheiden, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Ostend, Belgium
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Woluwe-Saint-Lambert, Belgium
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Milan, Italy
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Naples, Italy
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Pisa, Italy
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Amsterdam, Netherlands
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Barcelona, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Aberdeen, United Kingdom
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom