Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

Conditions

• Mucinous Adenocarcinoma of the Colon
• Mucinous Adenocarcinoma of the Rectum

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  IV infusion per institutional guidelines and the Package Insert
• Ipilimumab — DRUG
  IV infusion per institutional guidelines and the Package Insert

Study Details

This is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.

Key Dates

Start date

Feb 15, 2019

Status verified

Sep 2022

Primary completion

Mar 6, 2021

Completion

Mar 6, 2021

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab and Ipilimumab
  Treatment will consist of Nivolumab 480mg every 4 weeks and Ipilimumab 1mg/kg every 8 weeks. Subjects will continue on study therapy until disease progression, unacceptable toxicity, withdrawal of consent, or 24 months of therapy.

Primary Outcome Measure

Number of Participants With Progression-Free Survival at 6 Months [ Time Frame: Start of treatment until 6 months later ]

Locations (1)

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