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

Browse trials for

• Melanoma 3,006

Keywords

• ipilimumab
• previously treated

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 248 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Eligibility criteria

Study arms

• Experimental
  First reinduction: Ipilimumab, 0.3 to 10 mg/kg

  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

• Experimental
  First reinduction: Ipilimumab, 3 to 10 mg/kg

  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

• Experimental
  First reinduction: Ipilimumab, 10 to 10 mg/kg

  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

• Experimental
  Extended maintenance: Ipilimumab, 0.3 mg/kg

  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

• Experimental
  Extended maintenance: Ipilimumab, 3 mg/kg

  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

• Experimental
  Extended maintenance: Ipilimumab, 10 mg

  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

• No intervention
  Follow-up

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

Interventions

• DrugIpilimumab

  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

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.

   Time frame: 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

1. Overall Survival (OS)

   OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.

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

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

   Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.

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

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

   irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.

   Time frame: 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

4. Progression-free Survival (PFS)

   PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.

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

Baseline characteristics

Publications

• 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. PubMed 25210016 ↗

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