Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504302-11-02 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| Kom Op Tegen Kanker | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate whether a combination of chemotherapy and immunotherapy can make surgery possible in adults with inoperable pleural mesothelioma (a type of cancer affecting the lung lining). The main questions it aims to answer are:
Can two cycles of neoadjuvant chemotherapy and dual immunotherapy, followed by surgery, be completed safely and effectively?
Does this treatment allow previously inoperable patients to become eligible for surgery and improve survival outcomes?
Participants will:
Receive two cycles of chemotherapy (cisplatin or carboplatin and pemetrexed)
Receive dual immunotherapy (nivolumab and ipilimumab)
Undergo evaluation by a multidisciplinary team to determine if surgery is possible
If operable, undergo extended pleurectomy/decortication surgery
Be followed for one year to assess side effects, quality of life, and survival
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | systemic treatment and surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemo-immunotherapy | Drug | Neoadjuvant chemotherapy (2 cycles of cisplatin OR carboplatin accord healthcare- investigator's choice - PLUS pemetrexed fresenius AND immunotherapy (2 cycles of Opdivo PLUS 1 cycle of Yervoy for inoperable T2-T3 TNM 9 patients with PM |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the percentage of successful completion of a neoadjuvant double chemotherapy / double immunotherapy regimen followed by surgery in a selected group of T2-T3 (according to TNM 9) patients with pleural mesothelioma. | The primary endpoint is the rate of success, which is defined as a composite endpoint of feasibility, efficacy and safety consisting of: Feasibility is defined at week 17 +/- 2 weeks after start of treatment and involves the successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy, being selected as operable thereafter, and having extended pleurectomy/decortication (P/D). AND Efficacy is defined as being alive and without signs of progressive disease at week 17 +/- 2 weeks after start of treatment AND Safety is defined as absence of grade 3-4 residual toxicity from systemic treatment and complete resolution of major complications (grade III - V) after surgery according to the Ottawa Thoracic Surgery Morbidity and Mortality Classification at week 17 +/- 2 weeks after start of treatment Patients who are still inoperable after successful completion of 2 cycles of neoadjuvant immunotherapy and chemotherapy are considered failure for the primary endp | The primary end point will be measured on week 17 +/-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. | Toxicity, assessed by CTC-AE scores. Chemotherapy and immunotherapy-related toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. At the end of Treatment on week 17 ± 2 weeks). The CTCAE Grade (1-5); higher scores indicate more severe adverse events. | The End of Treatment will be at 17 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. J. Hendriks, MD. PhD. | Contact | +3238214361 | jeroen.hendriks@uza.be |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Recruiting | Edegem | Antwerp | 2650 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Extended pleurectomy/decortication in case of reaching operability | Procedure | After the systemic treatment the surgery will follow if patient is operable. |
|
| Toxicity of the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. | Toxicity, assessed by the Ottawa scores for surgery. Postoperative surgical complications are assessed using the Ottawa Thoracic Morbidity and Mortality Classification. At End of Treatment on week 17 ± 2 weeks, including postoperative period. The Ottawa classification Grade (I-V); higher grades indicate more severe complications. | The End of Treatment will be at 17 weeks |
| Efficay of neoadjuvant double chemotherapy / double immunotherapy regimen in inoperable T2-3 PM patients. | Efficacy, assessed by the percentage of T2 and T3 PM patients becoming operable after double neoadjuvant chemotherapy and immunotherapy which is defined by the radiology department using the TNM 9 criteria. | operability will be evaluated after systemic treatment on week 7-9. |
| Quality of life during the neoadjuvant double chemotherapy / double immunotherapy regimen and surgery. | Quality of life, assessed by the EQ-5D-5L score. The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a standardized instrument for measuring health-related quality of life. The EQ-5D-5L consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 response levels. In addition, it includes a visual analogue scale (EQ-VAS) for self-rated health. Time Frame: At baseline, Day 1 of each treatment cycle, pre-surgery, End of Treatment (Week 17 ± 2 weeks), and follow-up visits at Weeks 13, 26, 39, and 52 after EoT. | at week 17 |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002541 | Cerebral Decortication |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided