Clinical trial NCT01973608: MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
Official title: A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma
MSB0010445
Dose limiting toxicity
Stereotactic body radiation therapy
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2013-10-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)
timeFrame: Baseline up to Day 21
Secondary outcomes:
measure: Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
timeFrame: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
measure: Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs
timeFrame: Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years
Other outcomes:
Locations:
city: Rockland
country: United States
facility: Please Contact U.S. Medical Information
state: Massachusetts
Study officials:
affiliation: EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: