NCT02610140 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-11-04

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 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS), [95% CI]

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outcome · POSTED

Overall Survival (OS), [95% CI]

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Disease Control Rate (DCR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Durable Response Rate (DRR)

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outcome · POSTED

Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma

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outcome · POSTED

Time to Worsening of Symptoms Characteristic of Mesothelioma

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outcome · POSTED

Time to Worsening of Pain

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outcome · POSTED

Percentage of Participants With Confirmed Improvement of Pain

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outcome · POSTED

Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)

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outcome · POSTED

Number of Deaths

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outcome · POSTED

Overall Survival (OS) - Addendum

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Drug Anetumab ravtansine given Intravenously (IV)
intervention Names
Drug: Anetumab ravtansine (BAY94-9343)
label
BAY94-9343
type
EXPERIMENTAL
description
Drug Vinorelbine given Intravenously
intervention Names
Drug: Vinorelbine
label
Vinorelbine
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
BAY94-9343
description
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.
name
Anetumab ravtansine (BAY94-9343)
type
DRUG
arm Group Labels
Vinorelbine
description
Starting dose: 30mg/m\^2 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.
name
Vinorelbine
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 248
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
measure
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 Outcomes

description
Overall survival (OS) was defined as time from randomization until death from any cause.
measure
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.
description
A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
measure
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.
description
A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients.
measure
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.
description
DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
measure
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.
description
A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more.
measure
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.
description
Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma.
measure
Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
time Frame
up to approx. 30 months (data cut-off: 31-May-2017)
description
Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS.
measure
Time to Worsening of Symptoms Characteristic of Mesothelioma
time Frame
up to approx. 30 months (data cut-off: 31-May-2017)
description
Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score.
measure
Time to Worsening of Pain
time Frame
up to approx. 30 months (data cut-off: 31-May-2017)
description
Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain.
measure
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.
description
TEAEs were defined as all AEs starting or worsening within the treatment period.
measure
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).
description
TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018.
measure
Number of Deaths
time Frame
Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
description
Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019.
measure
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

Full 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 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.

Source references

references

citation
Kindler HL, Novello S, Bearz A, Ceresoli GL, Aerts JGJV, Spicer J, Taylor P, Nackaerts K, Greystoke A, Jennens R, Calabro L, Burgers JA, Santoro A, Cedres S, Serwatowski P, Ponce S, Van Meerbeeck JP, Nowak AK, Blumenschein G Jr, Siegel JM, Kasten L, Kochert K, Walter AO, Childs BH, Elbi C, Hassan R, Fennell DA. Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial. Lancet Oncol. 2022 Apr;23(4):540-552. doi: 10.1016/S1470-2045(22)00061-4.
pmid
35358455
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice