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MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01973608
First received: October 25, 2013
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Melanoma
Drug: MSB0010445 (0.3 milligram per kilogram [mg/kg])
Drug: MSB0010445 (1.0 mg/kg)
Drug: MSB0010445 (1.5-3.6 mg/kg)
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety Study for MSB0010445 in Combination With Stereotactic Body Radiation in Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Number of subjects with at least 1 Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 25 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best Overall Response According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Screening up to 4 weeks after last dose administration ] [ Designated as safety issue: No ]
  • Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to 4 weeks after last dose administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 86
Study Start Date: February 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSB0010445 (Low Dose) Drug: MSB0010445 (0.3 milligram per kilogram [mg/kg])
MSB0010445 will be administered at a dose of 0.3 mg/kg as intravenous infusion over approximately 1 hour every 3 weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT will be administered at a dose of up to 24 Gray (Gy) on a maximum of 1 lesion or, if the irradiated lesion is located in the thorax, up to 18 Gy.
Experimental: MSB0010445 (Intermediate Dose) Drug: MSB0010445 (1.0 mg/kg)
MSB0010445 will be administered at a dose of 1.0 mg/kg as intravenous infusion over approximately 1 hour every 3 weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT will be administered at a dose of up to 24 Gray (Gy) on a maximum of 1 lesion or, if the irradiated lesion is located in the thorax, up to 18 Gy.
Experimental: MSB0010445 (High Dose) Drug: MSB0010445 (1.5-3.6 mg/kg)
MSB0010445 will be administered at a total dose range of 1.5-3.6 mg/kg as intravenous infusion over approximately 1 hour every 3 weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. If the dose of 1.8 mg/kg is not tolerated, then 1.5 mg/kg will be administered.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
SBRT will be administered at a dose of up to 24 Gray (Gy) on a maximum of 1 lesion or, if the irradiated lesion is located in the thorax, up to 18 Gy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973608

Contacts
Contact: US Medical Information 888-275-7376

Locations
United States, Massachusetts
Please Contact U.S. Medical Information Recruiting
Rockland, Massachusetts, United States
Contact    888-275-7376      
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01973608     History of Changes
Other Study ID Numbers: EMR 062235-005
Study First Received: October 25, 2013
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Melanoma
MSB0010445
Dose limiting toxicity
Stereotactic body radiation therapy

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 25, 2014