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

• ClinicalTrials.gov Identifier: NCT01709162
• Recruitment Status: Terminated
• First Posted: October 18, 2012
• Results First Posted: November 30, 2015
• Last Update Posted: November 30, 2015
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Melanoma	Biological: Ipilimumab; Drug: Chemotherapy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Biological: Ipilimumab; Other Names: Yervoy; BMS-734016
Active Comparator: Chemotherapy; Participants received the investigator's choice of chemotherapy, administered per package instructions.	Drug: Chemotherapy

Outcome Measures

Primary Outcome Measures :

1. Overall Survival [ Time Frame: 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 :

1. Disease Control Rate (DCR) [ Time Frame: 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.
2. Best Overall Response Rate (BORR) [ Time Frame: 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.

Other Outcome Measures:

1. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs) [ Time Frame: From Day 1 of treatment to 90 days after last dose (or to death date for death information) ]
   AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Birmingham Hematology & Oncology Associates Llc

Birmingham, Alabama, United States, 35205

United States, Colorado

Rocky Mountain Cancer Centers

Aurora, Colorado, United States, 80012

United States, Indiana

Investigative Clinical Research Of Indiana, Llc

Indianapolis, Indiana, United States, 46260

United States, Kansas

Cancer Center Of Kansas

Wichita, Kansas, United States, 67214

United States, Nevada

Comprehensive Cancer Center Of Nevada

Las Vegas, Nevada, United States, 89148

United States, Pennsylvania

Lehigh Valley Hospital

Allentown, Pennsylvania, United States, 18103

United States, Texas

Texas Oncology Sammons Cancer Center

Dallas, Texas, United States, 75246

Austria

Local Institution

Wien, Austria, A-1090

France

Local Institution

Bordeaux, France, 33075

Local Institution

Nantes Cedex 1, France, 44093

Local Institution

Paris, France, 75010

Germany

Local Institution

Erfurt, Germany, 99089

Local Institution

Goettingen, Germany, 37075

Local Institution

Heidelberg, Germany, 69115

Local Institution

Kiel, Germany, 24105

Local Institution

Koln, Germany, 50937

Italy

Local Institution

Siena, Italy, 53100

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS clinical trial educational resource 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01709162
• Other Study ID Numbers: CA184-243; 2012-003291-38 ( EudraCT Number )
• First Posted: October 18, 2012
• Results First Posted: November 30, 2015
• Last Update Posted: November 30, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Ipilimumab; Antineoplastic Agents, Immunological; Antineoplastic Agents