A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM (NCT05918107) | Clinical Trial Compass
CompletedPhase 2
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
China31 participantsStarted 2022-08-13
Plain-language summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;
. Male or female, aged ≥18 years;
. Malignant mesothelioma confirmed by histology, without indication for surgery;
. Have not received systemic anti-tumor therapy in the past (if the subject has received neoadjuvant or adjuvant chemotherapy in the past, the last treatment time must be more than 6 months from the time of recurrence);
. Sufficient organ function;
. Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0-1;
. Expected survival period ≥ 12 weeks;
. There is at least one measurable lesion (malignant pleural mesothelioma is based on mRECIST version 1.1, and malignant mesothelioma in other parts is based on RECIST version 1.1).
Exclusion criteria
. History of severe allergic diseases, severe drug (including unmarked test drug) allergy history, or known allergy to any component of the drug in this study;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Brain parenchymal metastases or meningeal metastases with clinical symptoms, judged by the investigators as not suitable for inclusion;
. Had other active malignant tumors within 5 years before starting the study drug treatment, except for malignant tumors that can be treated locally and cured (such as skin basal cell or squamous cell carcinoma, superficial or non-invasive bladder cancer), cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma);
. Currently there are uncontrollable pleural, pericardial, and peritoneal effusions, and those with catheter drainage also need to be excluded;
. Unexplained fever \> 38.5°C before starting the study treatment (judged by the investigator, fever caused by tumor can be included in the group);
. There is uncontrollable tumor-related pain, and those who need analgesic treatment should have a stable analgesic treatment plan at the time of screening; asymptomatic metastatic lesions, if they grow further, may cause dysfunction or intractable pain (such as current and spinal cord compression unrelated epidural metastases), local therapy should be considered before screening if appropriate;
. Currently have clear interstitial lung disease or non-infectious pneumonia, except radiation pneumonitis caused by local radiotherapy;