NCT02406183

Trial of SBRT With Concurrent Ipilimumab in Metastatic Melanoma

Phase I Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Immune Checkpoint Inhibitors in Metastatic Melanoma: Dose Limiting Toxicity and Abscopal Effect

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Radiotherapie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The safety profiles of ipilimumab and SBRT are well studied separately 22-24, but prospective data on the combination of ipilimumab and high-dose SBRT are lacking. Consequently, the first goal of the proposed prospective phase I trial is to assess the safety (dose limiting toxicity, DLT) of the combination of high-dose SBRT and ipilimumab in patients with advanced melanoma.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-04-02
• Last updated: 2017-01-10

Locations

1 site across 1 country: Belgium