Actively Recruiting
Phase II Open-label Trial of Neoadjuvant Immunotherapy (Atezolizumab) with CAPOX Chemotherapy for Resectable Non-metastatic pMMR Colon Cancer
Led by Baylor College of Medicine · Updated on 2025-05-25
28
Participants Needed
1
Research Sites
69 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
Researchers are evaluating a Phase II open-label trial of neoadjuvant immunochemotherapy using Atezolizumab combined with CAPOX chemotherapy, followed by surgery and possibly adjuvant chemotherapy for patients with localized resectable proficient mismatch repair (pMMR) adenocarcinoma of the colon. The study aims to assess the safety, feasibility, and clinical response of this combination, focusing on immune cell changes in surgically removed colon tumors. The target enrollment is 28 patients. Participants will receive 4 cycles of Atezolizumab given prior to 4 cycles of CAPOX chemotherapy over 12 weeks before standard surgical tumor removal. After surgery, patients at high risk of cancer recurrence may receive further adjuvant chemotherapy with either mFOLFOX6 or CAPOX regimens, depending on the treating oncologist's decision. Blood samples will be collected throughout the study to analyze circulating tumor DNA (ctDNA) as an early marker of treatment effectiveness. During the study, patients will have baseline assessments including physical exams, imaging, blood, and stool collections, with continued monitoring during neoadjuvant therapy cycles. After surgery, follow-up visits occur at 2 weeks, 3 months, and 6 months to monitor health, ctDNA levels, quality of life, and treatment effects. Long-term follow-up visits occur every 6 months up to 36 months with optional research assessments. Safety, tumor response, quality of life, and survival outcomes will be measured throughout the study.
CONDITIONS
Brief 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 consent
- Ability to follow study procedures
- MSS or pMMR tumor confirmed by local testing
- Histologically confirmed resectable non-metastatic adenocarcinoma of the colon
- Tumor located at least 12 cm from the anal verge
- Presence of one or more high-risk features: elevated CEA levels, low lymphocyte-to-monocyte ratio, poor tumor differentiation, lymphovascular invasion, perineural invasion, T3 or T4 tumor with size ≥4 cm, or regional lymphadenopathy
- ECOG performance status 0-1
- Adequate blood counts and organ function within 14 days before treatment
- Negative hepatitis B, hepatitis C, and HIV tests
- Women of childbearing potential must agree to use effective contraception or abstinence during and after treatment
- Men must agree to use contraception or abstinence during and after treatment
You will not qualify if you...
- Symptomatic, untreated, or progressing metastatic disease
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or effusions
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune diseases or immune deficiencies, except controlled hypothyroidism, Type 1 diabetes, and certain skin conditions meeting strict criteria
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease within 3 months before treatment
- Major surgery within 4 weeks before treatment
- History of other malignancies within 5 years except low-risk cancers
- Severe infection within 4 weeks before treatment
- Recent therapeutic antibiotics use within 2 weeks before treatment
- Prior allogeneic stem cell or organ transplant
- Conditions increasing risk or interfering with study drug use
- Recent live vaccine within 4 weeks before treatment or planned during treatment
- Current antiviral therapy for hepatitis B
- Synchronous or prior invasive colon cancers
- Recent investigational therapy within 28 days before treatment
- Prior treatment with immune checkpoint inhibitors or CD137 agonists
- Recent systemic immunostimulatory or immunosuppressive therapies within specified time frames
- History of severe allergic reactions to similar antibodies
- Known allergies to study drug components
- Pregnancy or breastfeeding, or intention to become pregnant during and after treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 4 cycles of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX chemotherapy before surgery. Various assessments and sample collections occur during therapy to monitor safety and treatment response.
4 visits (one per 3-week cycle) plus 1 presurgical evaluation visit 2 to 8 weeks after therapy completion
Duration - Up to 1 week
Participants undergo surgical removal of the tumor according to standard-of-care practices.
1 visit (in-person) for surgery
Duration - 6 months
Participants are followed for efficacy and safety after surgery with visits at week 2, month 3, and month 6. High-risk participants may receive additional adjuvant chemotherapy during this phase.
3 visits (week 2, month 3, month 6)
Duration - Months 12 to 36
Participants are monitored for long-term outcomes including quality of life, adverse events, and survival with visits at months 12, 18, 24, 30, and 36.
5 visits (months 12, 18, 24, 30, 36)
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
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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