Clinical Trials, Colorectal Cancer, Phase III, Stage III Colorectal Cancer

Maintenance Immunotherapy for High-Risk Colorectal Cancer

Maintenance Immunotherapy for High-Risk Colorectal Cancer

Maintenance immunotherapy trial for high-risk colorectal cancer. Phase III study testing pembrolizumab after chemotherapy to prevent recurrence.

Phase III Trial of Maintenance Immunotherapy After Standard Treatment in High-Risk Colorectal Cancer

Full Title 

A randomized, double-blind, placebo-controlled phase III study of pembrolizumab maintenance therapy versus placebo in patients with high-risk stage III colorectal cancer after completion of standard adjuvant chemotherapy

Purpose

After completing standard treatment for high-risk colorectal cancer, this study tests whether continuing with immunotherapy for two years helps prevent cancer from coming back. The goal is to train your immune system to recognize and eliminate any remaining cancer cells.

Primary Objectives

  • Compare disease-free survival between pembrolizumab maintenance and placebo groups
  • Evaluate overall survival and time to distant metastasis
  • Assess safety and quality of life during extended immunotherapy treatment

Diseases

Who Can Join this Trial

To participate in this study, you must meet ALL of the following criteria

  • Have completed curative-intent surgical resection for stage III colorectal adenocarcinoma
  • Must have high-risk features: T4 disease, N2 disease, poorly differentiated histology, or lymphovascular invasion
  • Have completed standard adjuvant chemotherapy within 4-10 weeks prior to enrollment
  • Have no evidence of residual or recurrent disease on baseline imaging
  • Have recovered from chemotherapy-related toxicities to grade ≤1
  • ECOG performance status 0-1
  • Age 18-80 years
  • Life expectancy ≥2 years
  • Adequate organ function including blood counts, liver, and kidney function
  • No history of inflammatory bowel disease or autoimmune conditions
  • No prior immunotherapy treatment
  • Willingness to comply with 2-year treatment and follow-up schedule

Access Clinical Trials

Locations

CONTACT

📞  Call Now: 1-800-NEOVITA (1-800-636-8482)

🌐  Online Scheduling: Schedule Your Consultation

📧  Email: info@neovitaoncology.com