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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02610140
• Date of registration: 09/11/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
• Scientific 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
• Date of first enrolment: December 3, 2015
• Target sample size: 248
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02610140
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Finland, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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 investigator in consultation with
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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mesothelioma

Intervention(s)

Drug: Vinorelbine

Drug: Anetumab ravtansine (BAY94-9343)

Primary Outcome(s)

Progression-free Survival (PFS), [95% CI] [Time Frame: From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)]

Secondary Outcome(s)

Durable Response Rate (DRR) [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.]

Objective Response Rate (ORR) [Time Frame: up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.]

Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma [Time Frame: up to approx. 30 months (data cut-off: 31-May-2017)]

Percentage of Participant With Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).]

Overall Survival (OS), [95% CI] [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.]

Duration of Response (DOR) [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.]

Number of Deaths [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.]

Overall Survival (OS) - Addendum [Time Frame: Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause]

Percentage of Participants With Confirmed Improvement of Pain [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.]

Time to Worsening of Pain [Time Frame: up to approx. 30 months (data cut-off: 31-May-2017)]

Disease Control Rate (DCR) [Time Frame: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.]

Time to Worsening of Symptoms Characteristic of Mesothelioma [Time Frame: up to approx. 30 months (data cut-off: 31-May-2017)]

Secondary ID(s)

2012-003650-88

15743

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ImmunoGen and MorphoSys

Results

• Results available: Yes
• Date Posted: 17/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02610140