Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMER… (NCT06155279) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study)
Italy41 participantsStarted 2024-11-06
Plain-language summary
This is a prospective, open-label, multi-site Phase II trial of pembrolizumab in combination with pemetrexed and cisplatin or carboplatin as neo-adjuvant therapy followed by surgery and adjuvant pembrolizumab in patients affected by resectable stage I-IIIa chemonaïve epithelioid/biphasic pleural mesothelioma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of surgical resectable stage I-IIIA treatment-naïve epithelioid/biphasic pleural mesothelioma will be enrolled in this study.
* Diagnosis of epithelioid/biphasic pleural mesothelioma must be histologically confirmed, preferably by video-assisted thoracoscopic surgery (VATS).
* At screening, complete surgical resection of the mesothelioma must be deemed achievable, as assessed by a multidisciplinary evaluation.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
* Measurable disease, defined as at least 1 lesion measured in two positions at three separate levels on transverse cuts of CT scan that is suitable for repeated assessment using modified Response Evaluation Criteria in Solid Tumours \[m-RECIST 1.1\] for pleural mesothelioma is preferred; however, inclusion of specific cases without measurable disease could be discussed with the medical monitor and during the multidisciplinary team discussion of the surgical centers.
* Histologically proved diagnosis of treatment-naive epithelioid/biphasic pleural mesothelioma.
* Surgical resectable disease \[stage I - II - IIIA (T1-3 - N0/1-M0) according to ninth TNM edition\].
* No previous surgical resection of mesothelioma.
* Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] b…
What they're measuring
1
Primary endpoint - To evaluate the activity of neo-adjuvant treatment by the determination of pathological complete response rate (pCR)
Timeframe: Pathological complete response will be evaluated following neoadjuvant treatment and within 6 weeks after the last dose of study intervention.