Trial document





This trial has been registered retrospectively.
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  DRKS00014063

Trial Description

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Title

Case register study to capture the efficacy of Ipilimumab and other therapies after treatment with Nivolumab or Pembrolizumab in Ipilimumab naive patients with stage IV or non-resectable stage III metastatic melanoma

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Trial Acronym

PD-Next

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URL of the Trial

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Brief Summary in Lay Language

A national, ambispective, observational multicentric case registry study in patients with advanced metastatic or non-resectable melanoma. Primary objective of this registry study is the collection of clinically important data on therapeutic efficacy of Ipilimimab and other therapies following failed PD-1 antibody therapy with Nivolumab or Pembrolizumab. Therefore data will be collected about treatment and follow-up according to routine local clinical practice up to 24 months after consent of patient.

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Brief Summary in Scientific Language

Aim:
Within this ambispective, observational, multicenter case registry study 130 patients diagnosed with advanced melanoma (histologically confirmed Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to initiate a treatment with ipilimumab or any other subsequent therapy following the failure of an anti-PD-1 therapy will be observed.
The 2 cohorts considered in the study design are the following:
- Patients who start treatment with ipilimumab monotherapy after failure of anti PD-1 therapy
- Patients who start any other systemic treatment after failure of anti PD-1 therapy.
The goal of this case register study is to gather clinically meaningful data regarding therapeutic effect of ipilimumab and other therapies following the treatment of PD-1 antibodies nivolumab and pembrolizumab in adult patients with metastatic melanoma.
Primary objective of this study among adult patients with unresectable or metastatic melanoma will be the rate of objective remissions (ORR) and disease control (DCR) of ipilimumab therapy following failure from PD-1 antibody therapy in real-life conditions in Germany in patients with metastatic melanoma.
Secondary endpoints will be progression free survival (PFS) and overall survival (OS).
Furthermore data will be used to descibe the safety profile of ipilimumab in terms of incidence rate, severity, time to resolution of AEs, and management of AEs.
The study will collect data primarily from dermato-oncologic care facilities in Germany, both office based and hospital based (community hospitals and university hospitals). Electronic case report forms will be used by study investigators or qualified research staff members to enter data. As part of the routine care, study investigators will evaluate or ask patients about their disease history, treatment history (including nivolumab), and any AE experienced since the previous clinical visit and the related information.
Follow up time for primary and secondary objectives in this register study will be up to 24 months and from start of treatment following anti PD-1 antibody treatment (index date). Study follow-up will close 12 months after the latest index date when all patients have been included in the register study.
Statistics:
Collected parameters will be analysed using descriptive statistics.

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Organizational Data

  •   DRKS00014063
  •   2018/03/07
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  •   yes
  •   Approved
  •   BO/14/2017, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   For this case register study, data about anti-PD 1 antibody treatment, following treatment and Follow-up every 3 months will be collected. Follow-up will be end 24 months after start of treatment following anti PD-1 antibody treatment.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

At the end of follow-up (12 months after the latest index date (index date =start of treatment following anti PD-1 antibody treatment) when all patients have been included in the register study) the final analysis is planned.
Objective responses will be classified as complete (CR) or partial remissions (PR) together giving the objective response rate (OR). This will be calculated with according 95 percent confidence intervals and tabulated for the total population treated with ipilimumab.
In addition, time to response will be described as well as duration of response.

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Secondary Outcome

- progression free survival (PFS) and overall survival (OS)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/01
  •   130
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- primary diagnosis of advanced melanoma (Stage III [unresectable] or Stage IV skin, ocular, or mucosal melanoma)
- Histologically confirmed diagnosis
- At least 18 years of age at time of treatment decision
- Ipilimumab naive patient with subsequent therapy after first line anti-PD-1 therapy failure

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Exclusion Criteria

- Patients with a current primary diagnosis of a cancer other than advanced melanoma
- Ipilimumab therapy prior to anti PD-1 treatment

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Addresses

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    • Elbekliniken Buxtehude, Skin Cancer Center
    • Mr.  Dr.  Peter  Mohr 
    • Am Krankenhaus 1
    • 21614  Buxtehude
    • Germany
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    • Elbekliniken Buxtehude, Skin Cancer Center
    • Mr.  Dr.  Peter  Mohr 
    • Am Krankenhaus 1
    • 21614  Buxtehude
    • Germany
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    • ONKODATAMED GmbH
    • Ms.  Jessica  Behne 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bristol-Myers Squibb GmbH & Co. KGaA
    • Arnulfstraße 29
    • 80636  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.