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Trial of SBRT With Concurrent Ipilimumab in Metastatic Melanoma

NCT02406183 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-01-10

No results posted yet for this study

Summary

The prognosis of advanced metastatic melanoma remains poor although a breakthrough has been achieved with the novel anti-CTLA-4 treatment (ipilimumab) for a subset of patients. Unfortunately, due to immune resistance, the majority of patients do not obtain long-lasting clinical benefit. Radiotherapy is able to interfere with immune resistance by inducing immunogenic cell death. Preclinical evidence indicates that combining radiotherapy with anti-CTLA-4 treatment increases response rates compared to single agent treatment. These data are supported by several spectacular clinical cases and one retrospective study. The investigators hypothesize that combining ipilimumab with radiotherapy will result in a higher response rate compared to ipilimumab or radiotherapy in monotherapy. Given the complexity of the interaction in anti-tumor immunity, the first goal of this project is to assess the safety of the combined treatment.

Conditions

  • Melanoma
  • Effects of Immunotherapy
  • Adverse Effect of Radiation Therapy

Interventions

RADIATION

Stereotactic body radiotherapy (SBRT)

The SBRT dose will be escalated in 3 steps as described above and will be given on d39, d41 and d43

DRUG

Ipilimumab

Ipilimumab 3mg/kg will be given IV on d1, d22, d43 and d64

Sponsors & Collaborators

  • Radiotherapie

    lead OTHER

Principal Investigators

  • Piet Ost, MD, PhD · University Hospital, Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Belgium

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 NCT02406183 on ClinicalTrials.gov