MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab

This is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).

Inclusion Criteria:

• Advanced unresectable or metastatic melanoma, previously treated with ipilimumab; anti-melanoma treatments, including anti-PD/PD-L1 or any other immunotherapy, are allowed provided no treatment from last dose of that treatment to trial enrolment

• Subjects need to have

  • one lesion that can be irradiated
  • at least 1 measurable lesion outside the radiation field, different from the lesion that will be irradiated
  • one lesion that can be biopsied before treatment with SBRT and MSB0010445
  • one lesion outside the radiation field that can be biopsied while on treatment with MSB0010445

• The lesion that is biopsied at Baseline can be the lesion that will be irradiated

• The lesion that will be biopsied while on treatment should not be a lesion that has been irradiated or biopsied at Baseline

• Signed written informed consent

• Male and female subjects at least 18 years of age

• Life expectancy greater than or equal to (>=) 4 months

• Eastern cooperative oncology group (ECOG) performance status of 0 or 1

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Active central nervous system metastasis
• Treatment with systemic anti-cancer therapy within the 30 days before the first dose of SBRT
• Pre-existing pericardial effusion or history of Grade >=2 pleural effusion or ascites within 3 months before first dose of SBRT
• Concurrent systemic therapy with steroids or other immunosuppressive agents except short-term systemic steroids for allergic reactions
• Other protocol defined exclusion criteria could apply