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Malignant Pleural MesotheliomaPhase 2NivoMesNCT02497508

Nivolumab in Patients With Recurrent Malignant Mesothelioma

A Phase 2 study testing nivolumab in people with Malignant Pleural Mesothelioma, run by The Netherlands Cancer Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Pleural Mesothelioma
What is being tested?
nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Jul 2015to Jul 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histological or cytological diagnosed malignant pleural mesothelioma and age >18 years.
  • Progressive disease after at least one course of chemotherapy.
  • Previous chemotherapy or experimental therapy ≥ 4 weeks ago.
  • Medically suitable for limited surgical intervention (pleural biopsies up to limited pleurectomy).
  • Not considered candidates for trimodality treatment (as part of a study).
  • Measurable or evaluable disease (see tumor response assessment).
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  • Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures including the approval of a second thoracoscopy or transthoracic pleural biopsy after the third course.
  • Radiotherapy is allowed when this is given for palliation, the interval is > 12 weeks and not all tumor is within the irradiation field.
  • WHO performance status 0 or 1 (see appendix 1).
  • Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
  • Hematology: Neutrophil count >= 1.5 x 109/l, Platelets >= 150 x 109/l, Hemoglobin >= 6,0 mmol/l.
  • Chemistry: Total serum bilirubin ≤ 1.5 times within the upper limits of normal (ULN); ASAT and ALAT <= 2.5x ULN, AP (alkaline phosphatases) < 5x ULN (unless bone metastases are present in the absence of any liver disease).
  • Age and Reproductive Status
  • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception to avoid pregnancy during treatment and for 23 weeks after the last dose of investigational drug.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the first dose of nivolumab.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year during treatment and for a period of 31 weeks after the last dose of investigational drug.
  • Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.

Who cannot join

  • Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency.
  • Inability to perform biopsies of the pleural lesions.
  • Symptomatic peripheral neuropathy >= grade 2 according to NCI CTC, version 4.0.
  • Presence of symptomatic CNS metastases.
  • Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition.
  • Impaired renal function: creatinine clearance less than 50ml/min.
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  • Concomitant administration to any other experimental drugs under investigation.
  • Patients are excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients are excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

About this study

Official title: A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study

This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection.

The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.

Read the detailed description

Patients will undergo pre- and post-treatment thoracoscopies/biopsies.

Being tested
nivolumab
Keywords
progressive disease after at least 1 course of chemotherapy
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02497508
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg
Receives: Drug: nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DCR

    The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.

    Measured: at 12 weeks

Secondary outcomes (6)

  1. PFS

    The time from the date of start of treatment to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause.

    Measured: Until progression, every 6 weeks up to 24 weeks.

  2. OS

    The time from date of start of treatment to the date of death

    Measured: every 8 weeks until death

  3. TTP

    The time from the date of start of treatment to the time of disease progression.

    Measured: Until progression, every 6 weeks up to 24 weeks.

  4. ORR

    The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects.

    Measured: Every 6 weeks up to 24 weeks.

  5. Safety and tolerability (The incidence of (serious) adverse events)

    The incidence of (serious) adverse events

    Measured: Participants will be followed fot the duration of the trial, an expected average of 6 weeks

  6. DCR

    The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497508
Sponsor's protocol ID
N14MPN
Acronym
NivoMes
Status last verified
Sep 2017
First submitted
6 Jul 2015
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Desai AP, Kosari F, Disselhorst M, Yin J, Agahi A, Peikert T, Udell J, Johnson SH, Smadbeck J, Murphy S, Karagouga G, McCune A, Schaefer-Klein J, Borad MJ, Cheville J, Vasmatzis G, Baas P, Mansfield A. Dynamics and survival associations of T cell receptor clusters in patients with pleural mesothelioma treated with immunotherapy. J Immunother Cancer. 2023 Jun;11(6):e006035. doi: 10.1136/jitc-2022-006035.

    PubMed 37279993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nivolumab in people with Malignant Pleural Mesothelioma, run by The Netherlands Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DCR (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.

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