Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER

PHASE2RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

June 15, 2025

Primary Completion Date

September 1, 2026

Study Completion Date

January 1, 2028

Conditions
Stage I Colon CancerStage II Colon CancerStage III Colon Cancer
Interventions
DRUG

Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2

Enrolled Participant will receive 4 cycles of neoadjuvant Atezolizumab (Tecentriq) followed by CAPOX chemotherapy prior to surgery. Each cycle is every 3 weeks. (12 weeks)

DRUG

Oxaliplatin injection 85mg/m2 + Leucovorin 400mg/m2 + 5-Fluorouracil 2400mg/m2

After Surgery, if patients are still considered at high risk (per treating investigator) subjects will be eligible to receive adjuvant chemotherapy with mFOLFOX6 Q2 weeks x 6 cycles (12 weeks) or CAPOX Q3 weeks x 4 cycles (12 weeks)

DRUG

Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2

After Surgery, if patients are still considered at high risk (per treating investigator) subjects will be eligible to receive adjuvant chemotherapy with mFOLFOX6 Q2 weeks x 6 cycles (12 weeks) or CAPOX Q3 weeks x 4 cycles (12 weeks)

Trial Locations (1)

77030

RECRUITING

Baylor College of Medicine, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Baylor College of Medicine

OTHER