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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Melanoma

Treatments: Biological: Ipilimumab; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01709162

CA184-243

2012-003291-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Ipilimumab, 3 mg/kg

Experimental group

Description:

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

Treatment:

Biological: Ipilimumab

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Chemotherapy