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

Phase 2

Terminated

• Conditions: Melanoma
• Interventions: Biological: Ipilimumab; Drug: Chemotherapy

• Registration Number: NCT01709162
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Study Start: 2013-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-09
• Results First Submitted: 2015-09-17
• Results First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Results First Posted: 2015-11-30
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ipilimumab, 3 mg/kg	Ipilimumab	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
Chemotherapy	Chemotherapy	Participants received the investigator's choice of chemotherapy, administered per package instructions.

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization to death or last known alive date, assessed up to 15.6 months	Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease	DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.
Best Overall Response Rate (BORR)	Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease	BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.

Trial Locations

Locations (8)

Birmingham Hematology & Oncology Associates Llc; 🇺🇸 Birmingham, Alabama, United States

Rocky Mountain Cancer Centers; 🇺🇸 Aurora, Colorado, United States

Texas Oncology Sammons Cancer Center; 🇺🇸 Dallas, Texas, United States

Cancer Center Of Kansas; 🇺🇸 Wichita, Kansas, United States

Investigative Clinical Research Of Indiana, Llc; 🇺🇸 Indianapolis, Indiana, United States

Comprehensive Cancer Center Of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Local Institution; 🇮🇹 Siena, Italy

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States