Clinical trial NCT01709162: Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
Official title: A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 31
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: 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.


Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization to death or last known alive date, assessed up to 15.6 months
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
measure: Best Overall Response Rate (BORR)
timeFrame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Other outcomes:
measure: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
timeFrame: From Day 1 of treatment to 90 days after last dose (or to death date for death information)
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology & Oncology Associates Llc
state: Alabama
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Wichita
country: United States
facility: Cancer Center Of Kansas
state: Kansas
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center Of Nevada
state: Nevada
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Wien
country: Austria
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Erfurt
country: Germany
facility: Local Institution
city: Goettingen
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Koln
country: Germany
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: