MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

Criteria

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