Nivolumab With Chemotherapy in Pleural Mesothelioma After Surgery

Conditions

• Pleural Mesothelioma Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin AUC 5 — DRUG
  chemotherapy iv
• Cisplatin 75 mg/m2 — DRUG
  chemotherapy iv
• Pemetrexed 500 mg/m2 — DRUG
  chemotherapy iv
• Nivolumab Injection — BIOLOGICAL
  Human monoclonal antibody

Study Details

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.

Key Dates

Start date

Feb 4, 2019

Status verified

Feb 2025

Primary completion

Jan 30, 2025

Completion

Jan 30, 2025

Study Design

Enrollment

92 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Carboplatin or Cisplatin and Pemetrexed
  Four cycles (q4w) platinum-based adjuvant chemotherapy i.v.: * carboplatin AUC5 or cisplatin 75 mg/m2 * pemetrexed 500 mg/m2
• Experimental: Carboplatin or Cisplatin and Pemetrexed + Nivolumab
  Four cycles (q4w) of a combination of platinum-based adjuvant chemotherapy and immunotherapy i.v.: * carboplatin AUC5 or cisplatin 75 mg/m2 * pemetrexed 500 mg/m2 * nivolumab 480 mg flat-dose. Followed by up to 12 cycles (q4w) maintenance immunotherapy: \- nivolumab 480 mg flat-dose i.v.

Primary Outcome Measure

Time-to-next-treatment (TNT) assessed according to Kaplan-Meier analysis [ Time Frame: From date of randomization, every 4 weeks up to 16 months until end of treatment ]