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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01709162
• Other study ID #: CA184-243
• Secondary ID: 2012-003291-38
• Status: Terminated
• Phase: Phase 2
• First received: October 12, 2012
• Last updated: October 27, 2015
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Ipilimumab

Drug:
• Chemotherapy

Locations

Country	Name	City	State
Austria	Local Institution	Wien
France	Local Institution	Bordeaux
France	Local Institution	Nantes Cedex 1
France	Local Institution	Paris
Germany	Local Institution	Erfurt
Germany	Local Institution	Goettingen
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kiel
Germany	Local Institution	Koln
Italy	Local Institution	Siena
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Birmingham Hematology & Oncology Associates Llc	Birmingham	Alabama
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Investigative Clinical Research Of Indiana, Llc	Indianapolis	Indiana
United States	Comprehensive Cancer Center Of Nevada	Las Vegas	Nevada
United States	Cancer Center Of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)	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.	From Day 1 of treatment to 90 days after last dose (or to death date for death information)	Yes
Primary	Overall Survival	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)	From randomization to death or last known alive date, assessed up to 15.6 months	No
Secondary	Disease Control Rate (DCR)	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.	Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease	No
Secondary	Best Overall Response Rate (BORR)	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.	Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease	No

External Links

•   BMS clinical trial educational resource
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