NCT05870800: NICER

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

Recruiting now Phase 2 Last updated 25 May 2025

What this trial tests

Phase 2 trial testing Tecentriq 1200 MG in 20 ML Injection + Capecitabine 1000 mg/m2 + Oxaliplatin 130 mg/m2 in Stage I Colon Cancer in 28 participants. Currently enrolling.

Timeline

15 June 2025

Primary endpoint
1 September 2026

1 January 2028

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	15 June 2025
Primary completion	1 September 2026
Estimated completion	1 January 2028
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Stage I Colon Cancer — all drugs for Stage I Colon Cancer →
• Stage II Colon Cancer — all drugs for Stage II Colon Cancer →
• Stage III Colon Cancer — all drugs for Stage III Colon Cancer →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 80, any sex, with Stage I Colon Cancer or Stage II Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mismatch repair-proficient tumor footprints in the sands of immune desert: mechanistic constraints and precision platforms.
   Majumder B, Nataraj NB, Maitreyi L, Datta S. · · 2024 · cited 3× · PMID 39100682 · DOI 10.3389/fimmu.2024.1414376