Chemoimmunotherapy for Colon Cancer
(NICER Trial)
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like systemic immunosuppressive medications or investigational therapies, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Atezolizumab, Tecentriq, Capecitabine, and Oxaliplatin for colon cancer?
Research shows that the combination of capecitabine and oxaliplatin is effective in treating advanced colorectal cancer, with response rates over 50% in first-line therapy. Additionally, Atezolizumab has been approved for use in other cancers, indicating its potential effectiveness in combination therapies.12345
Is chemoimmunotherapy for colon cancer safe?
The safety of chemoimmunotherapy for colon cancer, involving drugs like capecitabine, oxaliplatin, and atezolizumab, has been studied in various trials. Capecitabine is generally well tolerated, with manageable side effects like hand-foot syndrome and diarrhea. Atezolizumab has an acceptable safety profile, with common side effects including fatigue and nausea, and some serious immune-related reactions like pneumonitis and hepatitis.678910
What makes the drug Atezolizumab, Capecitabine, Oxaliplatin unique for colon cancer treatment?
This treatment combines Atezolizumab, a drug that helps the immune system fight cancer by targeting a specific protein (PD-L1), with chemotherapy drugs Capecitabine and Oxaliplatin. Atezolizumab is unique because it is a type of immunotherapy that has shown promise in treating certain types of colorectal cancer, especially in patients with specific genetic features (dMMR), offering a novel approach compared to traditional chemotherapy alone.1112131415
Research Team
Atif Iqbal
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for adults over 18 with resectable, non-metastatic colon cancer that's not spread and has specific molecular features (pMMR). They must be able to follow the study plan, have certain high-risk factors like large tumors or signs of spreading to lymph nodes, and be in good physical condition. People can't join if they've had severe lung disease, recent heart issues, major surgery within a month, active infections including TB or hepatitis B/C/HIV, received live vaccines recently, are pregnant/breastfeeding or planning pregnancy soon.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Therapy
Participants receive 4 cycles of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX over 12 weeks before surgery
Surgery
Surgical removal of the tumor is performed per standard-of-care practices
Efficacy Follow-up
Participants are monitored for efficacy and safety during the first 6 months post-surgery
Adjuvant Chemotherapy
High-risk patients receive adjuvant chemotherapy based on the discretion of the treating oncologist
Long-term Follow-up
Participants are followed for survival and recurrence every 6 months from month 12 to month 36
Treatment Details
Interventions
- Atezolizumab
- Capecitabine, Oxaliplatin
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD