Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ipilimumab, 3 mg/kg

Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Chemotherapy

Participants received the investigator's choice of chemotherapy, administered per package instructions.

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

Interventions

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Ipilimumab

Intervention Type BIOLOGICAL

Chemotherapy

Intervention Type DRUG

Other Intervention Names

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Yervoy BMS-734016

Eligibility Criteria

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Inclusion Criteria

* Histologic diagnosis of unresectable stage III or IV metastatic melanoma
* Prior ipilimumab induction treatment (3 mg/kg)
* Documented disease control \[Stable Disease ≥3 months or Partial Response/Complete Response\] after ipilimumab induction
* Documented progressive disease following disease control

Exclusion Criteria

* Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
* Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
* Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
* Patients with a prior irAE that has not improved to grade 1 or better at randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

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United States Austria France Germany Italy

Other Identifiers

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2012-003291-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA184-243

Identifier Type: -

Identifier Source: org_study_id

Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Ipilimumab, 3 mg/kg

Ipilimumab

Chemotherapy

Chemotherapy

Interventions

Ipilimumab

Chemotherapy

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Bristol-Myers Squibb

Responsible Party

Principal Investigators

Bristol-Myers Squibb

Locations

Birmingham Hematology & Oncology Associates Llc

Rocky Mountain Cancer Centers

Investigative Clinical Research Of Indiana, Llc

Cancer Center Of Kansas

Comprehensive Cancer Center Of Nevada

Lehigh Valley Hospital

Texas Oncology Sammons Cancer Center

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Local Institution

Countries

Related Links

Other Identifiers

2012-003291-38

CA184-243