Malignant Pleural MesotheliomaPhase 1NCT04162015
A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma
A Phase 1 study testing Nivolumab, Pemetrexed and Cisplatin or Carboplatin in people with Malignant Pleural Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery. 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, Pemetrexed and Cisplatin or Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Nov 2019to Nov 2027
- Phase
- Phase 1
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
- Age ≥ 18 years
- Karnofsky performance status > 70%
- Pathologic diagnosis of malignant pleural mesothelioma.
- Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon
- Negative serum pregnancy test in women of childbearing potential
- Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer
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- Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer
- Adequate archival or fresh tissue for correlative analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible
- Absolute neutrophil count ≥ 1000/mcL
- Total bilirubin ≤ 1.5 mg/dl
- AST and ALT ≤ 3.0 x upper limit of normal
- Creatinine ≤ 1.5 x upper limit of normal
- Negative HIV serology blood test
Who cannot join
- Prior treatment with chemotherapy or immunotherapy for mesothelioma
- Autoimmune disease requiring systemic immune modulating treatment during the past two years
- Pregnant or lactating women
- Known active hepatitis B or hepatitis C
- Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid)
- Serious concurrent medical illness or another active cancer requiring treatment
- Active pneumonitis
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memoiral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Feasibility and Safety of Neoadjuvant Nivolumab and Chemotherapy for Resectable Malignant Pleural Mesothelioma
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Nivolumab, Pemetrexed, Cisplatin or Carboplatin
- Keywords
- Nivolumab, Surgery, Pemetrexed, Cisplatin, Carboplatin, 19-272
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
nivolumab 360 mg
PemetrexedDrug
500 mg/m^2
Cisplatin or CarboplatinDrug
cisplatin 75 mg/m2 or carboplatin AUC=5
| Study group | Role | What they receive |
|---|---|---|
| nivolumab with pemetrexed and cisplatin or carboplatin | Experimental | Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication. Receives: Drug: Nivolumab; Drug: Pemetrexed; Drug: Cisplatin or Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients going to operating room for surgical resection
Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint.
Measured: 30 days of the initially planned date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start12 Nov 2019
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single institution pilot study of nivolumab with pemetrexed and cisplatin or carboplatin prior to surgery for patients with potentially resectable malignant pleural mesothelioma (MPM).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Michael Offin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162015
- Sponsor's protocol ID
- 19-272
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.