NCT03984578

Window of Opportunity Study in Colorectal Cancer

Window of Opportunity Study With Neoadjuvant Pembrolizumab in Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a window of opportunity translational study investigating the use of pre-operative pembrolizumab and chemotherapy or chemoradiotherapy in non-metastatic colorectal cancer.

Detailed description

Patients with radiologically-assessed locally advanced non-metastatic colorectal cancer will receive the following treatment before surgery: Newly Diagnosed Colon cancers: One cycle of CAPEOX chemotherapy Two cycles of Pembrolizumab on Day 1 (concurrent with CAPEOX chemotherapy) and Day 22. Newly Diagnosed Rectal cancers: Following completion of chemo-radiotherapy with 5-fluorouracil (5-FU)/ capecitabine, patients will receive 2 cycles of Pembrolizumab given 3 weeks apart. Colon and Rectal Cancer Patients Referred for Pre-Operative Chemotherapy: Neoadjuvant pembrolizumab 200 mg 3-weekly for a maximum of 6 doses to be administered along with XELOX chemotherapy and additional 1 dose pembrolizumab 200 mg followed by standard of care (SOC) tumour resection. Pre-operative biopsy and surgical samples as well as blood will be collected for translational studies.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CAPEOX	Oral Capecitabine: 1000mg/m2 twice a day from Day 1 to 14 of a 3-week cycle, and IV Oxaliplatin: 130mg/m2 on Day 1
DRUG	Pembrolizumab	IV infusion of 200mg on Day 1 and Day 22
DRUG	Capecitabine/ 5-FU	Capecitabine: Oral dose of 825mg/m2/day twice a day on radiation days with concurrent radiation median 50.4 Gy/ 28 fractions; or 5-FU: 225mg/m2/day concurrent with radiation
DRUG	Pembrolizumab	IV infusion of 200mg on Day 1 of each cycle
DRUG	CAPEOX/Pembrolizumab	* Oral Capecitabine: 1000mg/m2 twice a day from Day 1 to 14 of a 3-week cycle. * IV Oxaliplatin: 130mg/m2 on Day 1 of a 3-week cycle. * Pembrolizumab: IV infusion of 200mg on Day 1 of a 3-week cycle.
DRUG	Pembrolizumab alone	IV infusion of 200mg 21 days from the last CAPEOX/Pembrolizumab combination dose.
PROCEDURE	Surgical resection	Performed after all medical intervention.

Timeline

• Start date: 2019-06-12
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2019-06-13
• Last updated: 2025-11-18

Locations

3 sites across 1 country: Singapore