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NOT YET RECRUITING
NCT07808151
PHASE2

Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer

Sponsor: Solstice Oncology, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Pembrolizumab

Administered to: Arm 1, Arm 2

DRUG

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