MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Drug: MSB0010445 (0.3 milligram per kilogram [mg/kg]); Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: MSB0010445 (2.4 mg/kg); Drug: MSB0010445 (1.8 mg/kg); Drug: MSB0010445 (1.0 mg/kg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01973608

EMR 062235-005

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

MSB0010445 Low Dose Cohort 0.3 mg/kg

Experimental group

Treatment:

Drug: MSB0010445 (0.3 milligram per kilogram [mg/kg])

Radiation: Stereotactic Body Radiation Therapy (SBRT)

MSB0010445 Intermediate Dose Cohort 1.0 mg/kg

Experimental group

Treatment:

Drug: MSB0010445 (1.0 mg/kg)

Radiation: Stereotactic Body Radiation Therapy (SBRT)

MSB0010445 High Dose Cohort 1.8 mg/kg

Experimental group

Treatment:

Drug: MSB0010445 (1.8 mg/kg)

Radiation: Stereotactic Body Radiation Therapy (SBRT)

MSB0010445 High Dose Cohort 2.4 mg/kg

Experimental group

Treatment:

Drug: MSB0010445 (2.4 mg/kg)

Radiation: Stereotactic Body Radiation Therapy (SBRT)