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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05870800
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stage I Colon Cancer
  • Stage II Colon Cancer
  • Stage III Colon Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2 — DRUG
    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)
  • Oxaliplatin injection 85mg/m2 + Leucovorin 400mg/m2 + 5-Fluorouracil 2400mg/m2 — DRUG
    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)
  • Oxaliplatin 130mg/m2 + Capecitabine 1000mg/m2 — DRUG
    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)

Study Details

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).

Key Dates

Start date
Jun 15, 2025
Status verified
May 2025
Primary completion
Sep 1, 2026
Completion
Jan 1, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Therapy Arm
    Subjects will receive 4 cycles of neoadjuvant atezolizumab in combination with 4 cycles of CAPOX before standard of care surgical resection. After surgery, patients who are still considered high risk for recurrence (per the treating medical oncologist) will be offered adjuvant therapy.

Primary Outcome Measure

Determine the rate of tumor regression grade 1 (<10% viable cancer cells) to neoadjuvant immunotherapy and chemotherapy in resectable (non-metastatic) pMMR colon cancer, assessed in the resection specimen. [ Time Frame: 3-5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Hector J Garcia-Chavez, MD
[email protected]
713-798-6419
Amy Wood
[email protected]
Atif Iqbal, MD (PRINCIPAL_INVESTIGATOR)
Shalini Makawita, MD (PRINCIPAL_INVESTIGATOR)
Benjamin Musher, MD (SUB_INVESTIGATOR)
Yesenia Rojas-Khalil, MD (SUB_INVESTIGATOR)
Tannaz Armaghany, MD (SUB_INVESTIGATOR)
Ernest R. Camp, MD (SUB_INVESTIGATOR)
Karen Riggins, MD (SUB_INVESTIGATOR)
Punam Parikh-Amin, MD (SUB_INVESTIGATOR)
Eric Silberfein, MD (SUB_INVESTIGATOR)
Cary Hsu, MD (SUB_INVESTIGATOR)
Carlos Farinas, MD (SUB_INVESTIGATOR)
Shilpa Jain, MD (SUB_INVESTIGATOR)

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Baylor College of Medicine· Houston, TX

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