Trial of SBRT With Concurrent Ipilimumab in Metastatic Melanoma

Sponsor
Radiotherapie
Study ID
NCT02406183
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic body radiotherapy (SBRT) — RADIATION
    The SBRT dose will be escalated in 3 steps as described above and will be given on d39, d41 and d43
  • Ipilimumab — DRUG
    Ipilimumab 3mg/kg will be given IV on d1, d22, d43 and d64

Study Details

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.

Key Dates

Start date
Mar 31, 2015
Status verified
Jan 2017
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SBRT, Ipilimumab)
    Drug: Ipilimumab Dosage: Ipilimumab will be administered intravenously at 3 mg/kg every 3 weeks for 4 cycles, Radiation: Stereotactic Body Radiotherapy Radiation therapy 24 Grays in 8 Grays fractions, Radiation therapy 30 Grays in 10 Grays fractions, Radiation therapy 36 Grays in 12 Grays fractions

Primary Outcome Measure

Maximal tolerated dose (MDT) that is associated with dose-limiting toxicity (DLT) in 25% of patients. [ Time Frame: 2 years ]

Related Studies