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Nivolumab With Chemotherapy in Pleural Mesothelioma After Surgery

NCT04177953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-02-06

No results posted yet for this study

Summary

Patients with malignant pleural mesothelioma stage I-III who have undergone cytoreductive surgery with curative intend consisting of extended pleurectomy / decortication (eP/D) with or without hyperthermic intrathoracic chemoperfusion (HITOC) who will receive a maximum treatment duration of 16 cycles (4 cycles of chemotherapy in both arms + 12 cycles maintenance immunotherapy in treatment arm B). The main objective of the trial is Time-to-next-treatment (TNT), as well as safety and tolerability.

Conditions

  • Pleural Mesothelioma Malignant

Interventions

DRUG

Carboplatin AUC 5

chemotherapy iv

DRUG

Cisplatin 75 mg/m2

chemotherapy iv

DRUG

Pemetrexed 500 mg/m2

chemotherapy iv

BIOLOGICAL

Nivolumab Injection

Human monoclonal antibody

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg

    collaborator UNKNOWN

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Rajiv Shah, MD · Thoraxklinik Heidelberg gGmbH, Medizinische Onkologie - Universitätsklinikum Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177953 on ClinicalTrials.gov