A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

NCT00162123 | Completed Phase 2 Results DMC

• 1 other identifier: CA184-025
• Study Type: interventional
• Target: 248
• Locations: 18 countries
• Sites: 58

Brief Summary

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Conditions

Melanoma

Keywords

ipilimumab; previously treated

Outcome Measures

Primary Outcomes (1)

• Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome

  An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is 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. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

  Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.

Secondary Outcomes (4)

• Overall Survival (OS)

  From first dose of study drug in parent study to death or date of last censoring.

• Percentage of Participants Surviving at 1, 1.5, and 2 Years

  From first dose of study drug in parent study to up to 2 years after reinduction

• Number of Participants With On-study Immune-related Adverse Events (irAEs)

  From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date

• Progression-free Survival (PFS)

  From day of first reinduction in current study to date of progression or death, whichever occurred first.

Study Arms (7)

First reinduction: Ipilimumab, 0.3 to 10 mg/kg

EXPERIMENTAL

Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Drug: Ipilimumab

First reinduction: Ipilimumab, 3 to 10 mg/kg

EXPERIMENTAL

Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Drug: Ipilimumab

First reinduction: Ipilimumab, 10 to 10 mg/kg

EXPERIMENTAL

Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 0.3 mg/kg

EXPERIMENTAL

Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 3 mg/kg

EXPERIMENTAL

Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 10 mg

EXPERIMENTAL

Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Drug: Ipilimumab

Follow-up

NO INTERVENTION

Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

Interventions

Ipilimumab DRUG

Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation

Also known as: BMS-734016, MDX-010

Extended maintenance: Ipilimumab, 0.3 mg/kg; Extended maintenance: Ipilimumab, 10 mg; Extended maintenance: Ipilimumab, 3 mg/kg; First reinduction: Ipilimumab, 0.3 to 10 mg/kg; First reinduction: Ipilimumab, 10 to 10 mg/kg; First reinduction: Ipilimumab, 3 to 10 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced melanoma
• Prior treatment in a prespecified prior/parent ipilimumab study
• Men and women 18 years of age and older
• First Reinduction:
• No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
• Had experienced documented progressive disease after expanded clinical benefit
• Extended Maintenance
• Received ipilimumab at any dose in a parent study
• Achieved expanded clinical benefit at the time of entry to current study
• Follow-up:
• Received ipilimumab at any dose in a closing parent study
• Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

You may not qualify if:

• Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
• Primary ocular or mucosal melanoma

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (58)

University Of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Wilshire Oncology Medical Group Inc

Laverne, California, 91750, United States

Location

The Angeles Clinic & Research Inst.

Los Angeles, California, 90025, United States

Location

Usc/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

San Francisco Oncology Associates

San Francisco, California, 94115, United States

Location

Local Institution

To Come, Connecticut, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana Oncology Hematology Consultants

Indianapolis, Indiana, 46202, United States

Location

St Joseph Oncology Inc

Saint Joseph, Missouri, 64507, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Christ Hospital Cancer Center Research

Cincinnati, Ohio, 45219, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Cancer Centers Of The Carolinas

Greenville, South Carolina, 29615, United States

Location

Center For Oncology Research & Treatment, P.A.

Dallas, Texas, 75230, United States

Location

Joe Arrington Cancer Research And Treatment Center

Lubbock, Texas, 79410, United States

Location

University Of Washington Medical Center

Seattle, Washington, 98109, United States

Location

Local Institution

Buenos Aires, Buenos Aires, CP1280AEB, Argentina

Location

Local Institution

Vienna, 1090, Austria

Location

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Wels, A-4600, Austria

Location

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Brussels, 1070, Belgium

Location

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Brussels, 1090, Belgium

Location

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Brussels, 1200, Belgium

Location

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Porto Alegre, Rio Grande do Sul, 90050, Brazil

Location

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Porto Alegre, Rio Grande do Sul, 90610, Brazil

Location

Local Institution

Jaú, São Paulo, 17210, Brazil

Location

Local Institution

Calgary, Alberta, T2N 4N2, Canada

Location

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Edmonton, Alberta, T6G 1Z2, Canada

Location

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Moncton, New Brunswick, E1C 6Z8, Canada

Location

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Olomouc, 775 20, Czechia

Location

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Aarhus C, 8000, Denmark

Location

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Brest, 29200, France

Location

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Lyon, 69373, France

Location

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Paris, 75010, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Berlin, D-12200, Germany

Location

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Heidelberg, 69120, Germany

Location

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Kiel, D-24105, Germany

Location

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Jerusalem, 91120, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Genova, 16132, Italy

Location

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Meldola (Fc), 47014, Italy

Location

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Rimini, 47900, Italy

Location

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Siena, 53100, Italy

Location

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Oslo, 0310, Norway

Location

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Lodz, 90553, Poland

Location

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Poznan, 61-866, Poland

Location

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Wroclaw, 51-124, Poland

Location

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Saint Petersburg, 191104, Russia

Location

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Stavropol, 355047, Russia

Location

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Voronezh, 394000, Russia

Location

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Johannesburg, Gauteng, 2199, South Africa

Location

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Cape Town, Western Cape, 7570, South Africa

Location

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Málaga, 29010, Spain

Location

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Valencia, 46009, Spain

Location

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Dnipro, 49044, Ukraine

Location

Related Publications (1)

• Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.

  PMID: 25210016 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Significant heterogeneity existed between patients, who rolled over from 6 studies assessing ipilimumab in different doses and combinations. Since not all eligible patients from parent studies were enrolled, some selection bias existed.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: May 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: April 1, 2014
• Last Updated: July 27, 2016
• Results First Posted: April 15, 2014

Record last verified: 2016-06

Locations

AR (1); DE (3); ES (2); ZA (2); AU (2); CA (3); US (19); BR (3); PL (3); BE (3); IL (2); DK (1); NO (1); FR (4); UA (1); IT (4); CZ (1); RU (3)