Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer

Conditions

• Metastatic Colorectal Carcinoma
• Stage IV Colorectal Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cetuximab — BIOLOGICAL
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Pharmacodynamic Study — OTHER
  Correlative studies
• Utomilumab — BIOLOGICAL
  Given IV

Study Details

This phase I trial studies the best dose and side effects of irinotecan hydrochloride when given with utomilumab and cetuximab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Monoclonal antibodies, such as utomilumab and cetuximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving utomilumab, cetuximab, and irinotecan hydrochloride may work better in treating patients with colorectal cancer.

Key Dates

Start date

Dec 27, 2017

Status verified

Jan 2026

Primary completion

Dec 30, 2025

Completion

Dec 30, 2025

Study Design

Enrollment

34 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (irinotecan hydrochloride, cetuximab, utomilumab)
  Patients receive irinotecan hydrochloride IV over 90 minutes and cetuximab IV over 1-2 hours on days 1 and 15, and utomilumab IV over 1 hour on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Recommended phase 2 dose of irinotecan hydrochloride (Dose escalation) [ Time Frame: Up to 4 years ]

Locations (1)

Find similar trials in Houston, TX

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