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Malignant Mesothelioma

This study observed 2-4 treatment cycles. For the convenience of statistics, this project stipulated that the first combined medication (v1) after the patient was enrolled in this study was administered with oncolytic virus (recombinant human adenovirus type 5) by intratumoral injection or intrapleural injection on the 1-3 days. On the 4th or 5th day, PD-1 injection was administered once per cycle. The completion of two visits in this study is considered a completed case, and subsequent treatment is determined jointly by the researcher and the subject.

The oncolytic virus(H101) is administered by intratumoral injection or intrapleural injection on days 1-3 of the first medication cycle. PD-1 inhibitor is administered on days 4 or 5, with one infusion per cycle. The treatment regimen consists of 2-4 cycles

Oncolytic Adenovirus H101

Programmed death receptor-1 inhibitor

Haitao Wang, Ph.D

Jinhuan Wang, Ph.D

Lili Wang, MM

Haitao Wang

Lili Wang

Jinhuan Wang

Dingkun Hou

Lei Wang

The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.

Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

Observation of the Efficacy and Safety of Oncolytic Adenovirus Injection Combined With Programmed Death Receptor Inhibitors in Treatment of Advanced Malignant Pleural Mesothelioma : a Single Center, Prospective, Case Registration Study

The proportion of CR(complete response) and PR(partial response) in all patients.

The proportion of CR(complete response), PR(partial response) and SD(stable disease) in all patients.

Refers to the time from the first treatment day to the first occurrence of disease progression or death from any cause (whichever occurs first), and the end point event is determined by the investigator according to RECIST version1.1.

Time between the date of grouping and death from any cause or the end of the last follow-up visit.

Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded.

Tianjin Medical University Second Hospital

Lurbinectedin 3.2 mg/m2 i.v. every 3 weeks (one cycle) until progression, unacceptable toxicity or patient's withdrawal.

Lurbinectedin

Yannis Metaxas, MD

Roger von Moos, Prof

Miklos Pless, MD

Federica Grosso, MD

Aim of this study is to provide the "proof of concept" of efficacy and tolerability of lurbinectedin monotherapy in progressive malignant mesotheliomas.

Malignant mesothelioma arises from the mesothelial cells of the pleural, peritoneal or pericardial lining and is often associated with asbestos exposition. There is no cure for most malignant mesotheliomas and the scope of all three major oncological therapeutic procedures (surgery, radiotherapy and chemotherapy) is to reduce/eliminate symptoms as well as to prolong progression free survival (PFS) and/or overall survival (OS). While progressive patients are still in good health able to undertake a second-line treatment, there is no standard treatment for progressive disease.

Lurbinectedin is a novel compound structurally related to trabectedin and with similar mode of action. Pre-clinical data showed a better safety profile than trabectedin. Lurbinectedin has been already tested in different Phase I-II trials showing promising activity in ovarian, pancreatic, breast, small and non-small cell lung cancer as well as in other tumor types, with objective responses averaging 30%, disease stabilization up to 75% and having manageable toxicity. Although lurbinectedin has not been widely tested in mesotheliomas, some mesothelioma patients have been already treated with lurbinectedin where again promising activity has been observed.

Prospective 2-stage single-arm open-label multicenter phase II trial.

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial

PFS at 12 weeks is defined as absence of progression or death due to any cause during 12 weeks (±2 weeks) after registration.

Patients with no tumor assessment at 12 weeks (±2 weeks) will be considered:

* Progressed at 12 weeks, if they have no following tumor assessment within the trial (patient died, refused, started a new treatment or was lost to follow-up) or if they progress at the following tumor assessment after 12 weeks (±2 weeks).
* Progression-free at 12 weeks, if they do not progress at the following tumor assessment after 12 weeks (±2 weeks).

PFS is defined as time from registration to one of the following events, whichever occurs first:

* Relapse or progression according to the modified RECIST criteria for malignant pleural mesothelioma
* Death due to any cause Patients not experiencing an event will be censored at the date of last evaluable tumor assessment before starting a subsequent treatment, if any.

OR is defined as complete response (CR) or partial response (PR) achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.

Patients without any tumor assessment during trial treatment will be regarded as having a non-evaluable response (NE) and shall be considered as failures for this endpoint.

DC is defined as CR, PR or stable disease (SD) for at least 12 weeks achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.

OS is defined as time from registration until death due to any cause. Patients alive or lost to follow-up will be censored at the last date they were known to be alive.

TTF is defined as time from registration until treatment discontinuation due to any reason (unacceptable toxicity, patient refusal, progression, death or any other event that determines the termination of the trial treatment).

Patients not experiencing an event will be censored at the date of their last available assessment or visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma	NCT06031636	Malignant Pleur...	Oncolytic Adeno... Programmed deat...	18 Years - 75 Years	Tianjin Medical University Second Hospital
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma	NCT06031636	Malignant Pleur...	Oncolytic Adeno... Programmed deat...	18 Years - 75 Years	Tianjin Medical University Second Hospital
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for malignant pleural mesothelioma, advanced