Priming tumors to unlock Immunotherapy's power

NCT ID NCT03519412

Completed Disease control Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a two-step approach for people with metastatic colorectal cancer that doesn't respond well to standard treatments. First, patients received a drug called temozolomide to make their tumors more genetically unstable. Then, they received the immunotherapy drug pembrolizumab (Keytruda). The goal was to see if this sequence could shrink tumors or slow their growth. The trial involved 107 participants and has been completed.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: temozolomide and pembrolizumab
What this could lead to: If it works, this could offer a new treatment option for people with a type of colorectal cancer that usually doesn't respond to immunotherapy.
What could go wrong: This is a small, early-phase trial (Phase 2) with only 107 participants. The approach is complex and may not work for everyone. Temozolomide can cause side effects like low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm Microsatellite Instability

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COLORECTAL NEOPLASMS MICROSATELLITE INSTABILITY

Contacts and locations

Locations

Grande Ospedale Metropolitano Niguarda

Milan, Italy
Istituto Clinico Humanitas

Rozzano, Italy
Istituto Europeo di Oncologia

Milan, Italy
Istituto Nazionale Tumori di Milano

Milan, Italy

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