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Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02610140
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).

210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.

Treatment will continue until centrally confirmed disease progression (PD) or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.

Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.


Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Anetumab ravtansine (BAY 94-9343) Drug: Vinorelbine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy
Actual Study Start Date : December 3, 2015
Primary Completion Date : May 31, 2017
Estimated Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BAY 94-9343
Drug Anetumab ravtansine given Intravenously (IV)
Drug: Anetumab ravtansine (BAY 94-9343)
Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
Active Comparator: Vinorelbine
Drug Vinorelbine given Intravenously
Drug: Vinorelbine
Starting dose: 30mg/m² administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Approx. 22 months ]
    Defined as time from randomization until disease progression or death. Patients not experiencing death or progression will be censored at the last tumor assessment.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approx. 42 months ]
    Defined as time from randomization until death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored at the last known alive date.

  2. Patient-reported outcomes (PROs) [ Time Frame: Approx. 22 months ]
    PROs: Time to worsening of symptoms characteristic of mesothelioma, time to worsening of pain, time to improvement of symptoms characteristic of mesothelioma and time to improvement of pain. Symptoms will be assessed using the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) and the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso).

  3. Objective response rate (ORR) [ Time Frame: Approx. 22 months ]
    A patient is a responder if the patient has a confirmed tumor response on-study of (complete response) CR or PR, as determined by the central radiological reviewer per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for MPM. The ORR in each arm is the number of responders divided by the number of randomized patients.

  4. Duration of response (DOR) [ Time Frame: Approx. 42 months ]
    Defined as proportion of patients achieving CR, PR, or (Stable disease) SD per mRECIST criteria, as determined by the central radiological reviewer.

  5. Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Approx. 22 months ]
  6. Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Approx. 22 months ]
  7. Disease control rate (DCR) [ Time Frame: Approx. 22 months ]
    Defined as proportion of patients achieving CR, PR, or (Stable disease) SD per mRECIST criteria, as determined by the central radiological reviewer.

  8. Durable Response Rate (DRR) [ Time Frame: Approx. 42 months ]
    Defined in responders as a responder with a duration of response of 180 days or more as determined by the central radiological reviewer.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
  • Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed.
  • Patients must have measurable disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function
  • Left ventricular ejection fraction (LVEF) ≥ 50% or the lower limit of normal (LLN) according to local institution ranges of normality.

Exclusion Criteria:

  • More than 1 previous systemic anti-cancer therapy line
  • Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the ophthalmologist.
  • Brain metastases, meningeal tumours or other metastases in the central nervous system
  • Evidence of history of bleeding diathesis.
  • Ongoing or active infection (bacterial, fungal, or viral) of National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade > 2.
  • Pre-existing cardiac conditions
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610140


  Show 99 Study Locations
Sponsors and Collaborators
Bayer
ImmunoGen and MorphoSys
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02610140     History of Changes
Other Study ID Numbers: 15743
2012-003650-88 ( EudraCT Number )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Vinorelbine
Vinblastine
Maytansine
Immunoconjugates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs