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A Study of IMM-101 in Combination With Checkpoint Inhibitor Therapy in Advanced Melanoma

NCT03711188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-04-29

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of the combination of IMM-101 with nivolumab.

Conditions

Interventions

DRUG

Nivolumab

Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.

DRUG

Ipilimumab

Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.

DRUG

IMM-101

A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.

Sponsors & Collaborators

  • Immodulon Therapeutics Ltd

    lead INDUSTRY

Principal Investigators

  • Alberto Fusi · St George's University Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03711188 on ClinicalTrials.gov