OncoMatch/Clinical Trials/NCT05870800
Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER
Is NCT05870800 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tecentriq 1200 MG in 20 ML and Oxaliplatin for stage i colon cancer.
Treatment: Tecentriq 1200 MG in 20 ML · Oxaliplatin · Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cannot have received: systemic immunostimulatory agent (interferon, interleukin 2)
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF- agents)
Exception: acute, low-dose or one-time pulse dose; mineralocorticoids; corticosteroids for COPD/asthma; low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency
Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study. Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
Cannot have received: investigational therapy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (1500/mL) without G-CSF support; Lymphocyte count ≥ 0.5 x 10^9/L (500/µL); Platelet count ≥100 x 10^9/L (100,000/µL) without transfusion; Hemoglobin ≥ 9 g/L (9 g/dL) (transfusion allowed); Serum albumin ≥ 25 g/L (2.5 g/dL)
Kidney function
Serum creatinine ≤1.5 x ULN or Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ≥ 1.5 x 10^9/L (1500/mL) without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 0.5 x 10^9/L (500/µL); Platelet count ≥100 x 10^9/L (100,000/µL) without transfusion; Hemoglobin ≥ 9 g/L (9 g/dL) Patients may be transfused to meet this criterion. AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN); Serum bilirubin ≤ 1.5 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN; Serum creatinine ≤1.5 x ULN or Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin ≥ 25 g/L (2.5 g/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor College of Medicine · Houston, Texas
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