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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administered to: Arm 1, Arm 2
Administered to: Arm 1, Arm 2
Investigator Site
Los Angeles, California, United States
Investigator Site
Tampa, Florida, United States
Investigator Site
Chicago, Illinois, United States
Investigator Site
Baltimore, Maryland, United States
Investigator Site
Boston, Massachusetts, United States
Investigator Site
New York, New York, United States
Investigator Site
New York, New York, United States
Investigator Site
New York, New York, United States
Investigator Site
Cleveland, Ohio, United States
Investigator Site
Nashville, Tennessee, United States
...and 20 more locations
Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR)
MPR is defined as the proportion of patients with ≤10% residual tumor volume in the primary tumor and lymph nodes, as evaluated by BIPR, per treatment arm
Time frame: Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose)
Pathologic Complete Response (pCR) rate
Time frame: Assessed from surgical resection specimen (Week 6-9)
Incidence of treatment-related adverse events (AEs), serious adverse events (SAEs), and immune-related AEs
Time frame: From informed consent through 60 days after last dose (or initiation of new anti-cancer treatment, whichever occurs first)
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