Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Pembrolizumab: Administered to: Arm 1, Arm 2

Porustobart: Administered to: Arm 1, Arm 2

Study 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

Eligibility

Primary outcome measure(s)

• Major Pathologic Response (MPR) rate by Blinded Independent Pathologic Review (BIPR) — Assessed from surgical resection specimen (surgery occurs Day 42-Day 63, i.e., approximately Week 6-Week 9 after first dose)
  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

Trial sites (30)