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

NCT05870800 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-05-25

No results posted yet for this study

Summary

This is a Phase II open-label trial of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX followed by surgery and potentially adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 28 patients. The investigators will explore if appropriately timed neoadjuvant CAPOX with anti-PD-L1 mAb (Atezolizumab) can be administered safely and feasibly, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors. Patients will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPOX (atezolizumab will be administered prior to chemotherapy) before standard of care surgical resection. Following surgery, patients still considered to be at high-risk of recurrence (per SOC guidelines) will receive further adjuvant chemotherapy (mFOLFOX6 or CAPOX), based on the discretion of the treating oncologist/investigator. Circulating tumor DNA (ctDNA) dynamic change status will be analyzed through collection of blood samples throughout different stages of the patient's neoadjuvant treatment regimen (baseline, pre-neoadjuvant therapy, mid-neoadjuvant, post-neoadjuvant therapy, and during postoperative period) as a marker of early read on efficacy.

The end of the study for each patient enrolled will be at the 6 month postoperative visit.

On Study Protocol: Patients will be followed up for an efficacy follow-up phase during the first 6 months after surgery (week 2 \& months 3, 6 visits). All assessments beyond the 6 month visit will be performed under standard of care surveillance office visits.

Off Study Protocol: Thereafter they will enter a survival follow-up phase per standard of care protocols. Patients will be seen every 6 months starting at month 12 until month 36. All collection of research-specific assessments including whole blood, stool collection and quality of life questionnaires will be optional beyond the 6 month postop visit (months 12-36).

Conditions

  • Stage I Colon Cancer
  • Stage II Colon Cancer
  • Stage 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)

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Atif Iqbal, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-09-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870800 on ClinicalTrials.gov