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MesotheliomaPhase 2MAPS2NCT02716272

Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

A Phase 2 study testing Nivolumab and Nivolumab + Ipilimumab in people with Mesothelioma, run by Intergroupe Francophone de Cancerologie Thoracique at 22 sites in France.

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

The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma
What is being tested?
Nivolumab and Nivolumab + Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
22 sitesFrance
Study dates
24 Mar 2016to 22 Jun 2019
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

  • Histologically proved diagnosis of unresectable malignant pleural Mesothelioma (MPM)
  • Available (archival and/or fresh) pathological samples for centralized PD-L1 expression assessment by immunohistochemistry
  • Age ≥ 18 years old; male and female
  • ECOG Performance status 0-1
  • Weight loss < 10% during last 3 months
  • Life expectancy > 12 weeks
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  • Documented progression of the MPM, assessed by computed tomography (CT) -Scan.
  • Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by CT-Scan and is suitable for repeated assessment using modified Response Evaluation Criteria in Solid Tumors [RECIST] for pleural mesothelioma (Byrne 2004; Therasse 2006).
  • Previous treatment by 1 or 2 systemic chemotherapy lines (1 line of chemotherapy considered if the patient received ≥2 cycles of this chemotherapy), including at least one line with pemetrexed in combination with platinum agent (i.e. "gold standard chemotherapy in MPM; triplet including bevacizumab also accepted)
  • Written informed consent
  • Patients must have adequate organ function : creatinine clearance > 50 mL/min (Cockcroft formula), Neutrophiles count > 1500/mm3; Platelets > 100 000/mm3 ; Hemoglobin > 9 g/dL; hepatic enzymes < 3N with total bilirubin ≤ 1.5 × ULN (upper limit of normal) except subjects with documented Gilbert's syndrome (≤ 5 × ULN) or liver metastasis, who must have a baseline total bilirubin ≤ 3.0 mg/dL
  • Recovered from all toxicities associated with prior treatment, to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.0) Grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 6 months after the final dose of investigational product. Men receiving nivolumab and who are sexually active with women of childbearing potential will be instructed to adhere to contraception for a period of 31 weeks after the last dose of nivolumab.

Who cannot join

  • Patients with primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
  • Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Patients with prostate adenocarcinoma diagnosed less than 5 years could be included in case of localized prostate cancer with good outcome according the Amico classification: ≤ T2a and Gleason Score ≤6 and PSA blood level ≤10 ng/ml, and treated with curative intent (surgery or radiotherapy) without chemotherapy. Patients with history of solid tumors, including adenocarcinoma, treated with curative intent and without any evidence of disease >5 years can be included as well.
  • Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy with no evolution within the 3 months before inclusion, and asymptomatic patient
  • History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Intranasal/inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Live attenuated vaccination administered within 30 days prior to randomization.
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  • Known history of interstitial lung disease (asbestosis…) or CT-scan signs of interstitial lung disease.
  • Subjects with an active, known or suspected autoimmune disease, including systemic lupus erythematosis or Wegener's granulomatosis. Subjects with type I diabetes mellitis, or hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, are permitted to enroll.
  • Active or history of inflammatory bowel disease (eg, diverticulitis, colitis, Crohn's), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea. Note that diverticulosis is permitted.
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
  • known prior history of active tuberculosis-disease;
  • known acute or chronic B or C hepatitis by serological evaluation. Patients with serological sequelae of hepatitis (antibodies test serologically positive for virus) without hepatitis could be included.
  • known Human immunodeficiency virus infection.
  • 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 checkpoint pathways
  • The last dose of prior chemotherapy or radiation therapy (with the exception of palliative radiotherapy) was received less than 3 weeks prior to randomization

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • Angers - CHU

    Angers, 49000

  • Avignon - Institut Sainte-Catherine

    Avignon, 84918

  • CHU

    Clermont-Ferrand

  • Dijon - CHU

    Dijon, 63000

  • Grenoble - CHU

    Grenoble, 38000

  • Centre Hospitalier - Pneumologie

    Le Havre, 76600

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • CHRU Lille - Hopital Calmette

    Lille

  • AP-HM Hôpital Nord

    Marseille

  • Mulhouse - CH

    Mulhouse, 68000

  • AP-HP Hopital Tenon - Pneumologie

    Paris, 75020

  • AP-HP Hôpital Bichat

    Paris

  • HCL Lyon Sud

    Pierre-Bénite, 69495

  • Pontoise - CH

    Pontoise

  • Rennes - CHU

    Rennes

  • Rouen - CHU

    Rouen, 76000

  • Centre Etienne Dolet

    Saint-Nazaire

  • CHU Strasbourg

    Strasbourg

  • Toulon - CHI

    Toulon, 83000

  • Toulouse - CHU Larrey

    Toulouse

  • CHU Tours - Pneumologie

    Tours

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.

Conditions
Mesothelioma
Being tested
Nivolumab, Nivolumab + Ipilimumab
Keywords
mesothelioma, immunotherapy, nivolumab, ipilimumab
Medical subject headings
Mesothelioma

What participants receive

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

  • NivolumabDrug

    Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks

  • Nivolumab + IpilimumabDrug

    Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks, combined with Ipilimumab administered IV over 90 minutes at 1mg/Kg every 6 weeks

Study groups in NCT02716272
Study groupRoleWhat they receive
MONOTHERAPY ARMExperimentalNivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks
Receives: Drug: Nivolumab
COMBINATION ARMExperimentalNivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks, combined with Ipilimumab administered IV over 90 minutes at 1mg/Kg every 6 weeks
Receives: Drug: Nivolumab + Ipilimumab

What is being measured

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

  1. Disease Control rate assessed by CT scan

    Tumor assessment (modified RECIST1.0 for mesothelioma)

    Measured: 3-months

Secondary outcomes (5)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    NCI CTC AE 4.0

    Measured: 3-months

  2. Progression-Free Survival

    Measured: 3-month

  3. Overall Survival

    Measured: 3-months

  4. Quality of Life

    LCSS ( Lawrence County School System) Scale

    Measured: 3-months

  5. prognosis impact of blood biomarkers (exploratory studies)

    dosage in blood of numerous biomarkers and analysis of their prognosis impact

    Measured: 3-months

Timeline

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

  1. First posted23 Mar 2016 (estimated)
  2. Study start24 Mar 2016
  3. Primary completionFeb 2018
  4. Study completion22 Jun 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716272
Sponsor's protocol ID
IFCT-1501
Acronym
MAPS2
Status last verified
Feb 2021
First submitted
9 Mar 2016
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Do P, Bylicki O, Monnet I, Corre R, Audigier-Valette C, Locatelli-Sanchez M, Molinier O, Guisier F, Urban T, Ligeza-Poisson C, Planchard D, Amour E, Morin F, Moro-Sibilot D, Zalcman G; French Cooperative Thoracic Intergroup. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16.

    PubMed 30660609

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Nivolumab + Ipilimumab in people with Mesothelioma, run by Intergroupe Francophone de Cancerologie Thoracique at 22 sites in France.

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 13 inclusion and 15 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Disease Control rate assessed by CT scan (time frame: 3-months). 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 NCT02716272, 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 10 Feb 2021.

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