Actively Recruiting
Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER
Led by Baylor College of Medicine · Updated on 2025-05-25
28
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at time of consent
- Ability to follow the study protocol
- Tumor confirmed as MSS or pMMR by certified local testing
- Histologically or cytologically confirmed resectable non-metastatic adenocarcinoma of the colon
- Tumor located at least 12 cm from the anal verge as determined by endoscopy or imaging
- Presence of one or more high-risk features such as elevated CEA levels, low lymphocyte-to-monocyte ratio, poor tumor differentiation, lymphovascular or perineural invasion, T3 or T4 disease with tumor size ≥4 cm, or regional lymphadenopathy
- ECOG performance status of 0 or 1
- Adequate blood and organ function based on laboratory tests within 14 days prior to treatment
- Negative tests for hepatitis B, hepatitis C, and HIV
- For women of childbearing potential, agreement to use effective contraception or remain abstinent during and after treatment
- For men, agreement to use contraception or remain abstinent during and after treatment
You will not qualify if you...
- Symptomatic, untreated, or actively progressing metastatic disease
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or metastatic effusions
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune or immune deficiency diseases, with some exceptions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant recent cardiovascular disease or unstable cardiac conditions
- Major surgery within 4 weeks before starting treatment
- History of other malignancies within 5 years except certain low-risk cancers
- Severe infection within 4 weeks before treatment
- Recent treatment with therapeutic antibiotics except prophylactic use
- Prior allogeneic stem cell or organ transplantation
- Any condition posing high risk or interfering with study treatment
- Recent live vaccine within 4 weeks before treatment or planned during study
- Current antiviral therapy for hepatitis B
- Synchronous rectal and/or colon cancers or prior invasive colon cancer
- Recent investigational therapy within 28 days before treatment
- Prior treatments with CD137 agonists or immune checkpoint inhibitors
- Recent systemic immunostimulatory or immunosuppressive treatments with some exceptions
- History of severe allergic reactions to similar antibodies or drugs
- Known allergies to study drugs or components
- Pregnancy, breastfeeding, or intention to become pregnant during or shortly after treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Hector J Garcia-Chavez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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