A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Pleural Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nivolumab with pemetrexed and cisplatin or carboplatin

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.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

nivolumab 360 mg

Pemetrexed

Intervention Type DRUG

500 mg/m\^2

Cisplatin or Carboplatin

Intervention Type DRUG

cisplatin 75 mg/m2 or carboplatin AUC=5

Interventions

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Nivolumab

nivolumab 360 mg

Intervention Type DRUG

Pemetrexed

500 mg/m\^2

Intervention Type DRUG

Cisplatin or Carboplatin

cisplatin 75 mg/m2 or carboplatin AUC=5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No