MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01973608
• Other study ID #: EMR 062235-005
• Status: Terminated
• Phase: Phase 2
• First received: October 25, 2013
• Last updated: October 8, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Please Contact U.S. Medical Information	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with at least 1 Dose Limiting Toxicity (DLT)		Up to Day 25	Yes
Secondary	Best Overall Response According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)		Screening up to 4 weeks after last dose administration	No
Secondary	Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)		Screening up to 4 weeks after last dose administration	Yes