Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Mesothelioma

Mesothelioma, Malignant

Disease Progression

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Nivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg

nivolumab

Paul Baas, MD, PhD

Josine Quispel-Janssen, MD

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.

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

Nivolumab in Patients With Recurrent Malignant Mesothelioma

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

The effects of nivolumab on tissue samples with respect to influx of immuno-modulating cells and the PD-L1 status of tumors and other possible biomarkers and explore correlations between biomarkers and anti-tumor activity.

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.

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.

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

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

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

The incidence of (serious) adverse events

Bristol-Myers Squibb

The Netherlands Cancer Institute

Ipilimumab

Nivolumab will be administered at a fixed dose of 240 mg every 2 weeks for a maximum period of 2 years. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19. Ipilimumab will be administered at the dose of 1 mg/Kg.

nivolumab and ipilimumab

Maria Disselhorst, MD

This is a prospective, monocenter, single arm, phase II trial in 33 patients with unresectable MPM, who experience disease progression or recurrence after at least one previous line of platinum-based systemic treatment.

Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21 thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 2 years or until disease progression or unacceptable toxicity occurs.

Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma

Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma: a Phase II Study. Acronym: INITIATE

The research will focus on re-activation and expansion of tumor-specific T cells. Multimer pMCH technology will be used to examine the quantitative changes in T cell responses and transcriptomic analysis of tumor infiltrating T-cells in biopsies taken before and after 6 weeks of treatment.

The number of patients that have CR or PR plus the number of patients with stable disease as a percentage of the total number of patients in the study.

Incidence of (serious) adverse events, serious adverse events, deaths and laboratory abnormalities.

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

The time from date of start of treatment to the date of death from any cause, every 6 weeks up to 48 weeks, thereafter every 12 weeks up to 36 months

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nivolumab in Patients With Recurrent Malignant Mesothelioma	NCT02497508	Malignant Pleur...	nivolumab	18 Years -	The Netherlands Cancer Institute
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma	NCT03048474	Malignant Pleur...	nivolumab and i...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for progressive disease after at least 1 course of chemotherapy