A randomized, open-label phase II/III study with dendritic cells loaded with allogeneic tumour cell lysate (PheraLys) in subjects with mesothelioma as maintenance treatment (MesoPher) after chemotherapy

Phase 2

Completed

Conditions: asbestos cancer
malignant pleural mesothelioma
10027412

Registration Number: NL-OMON55474

Lead Sponsor: Amphera B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 118

Inclusion Criteria

- Signed informed consent within 8 weeks of their last chemo and the date of
the informed consent must be such that it is possible to schedule the first
study treatment 9 to 13 weeks after their last chemo therapy.
- Histologically confirmed diagnosis of pleural malignant mesothelioma,
non-progressive after 4 to 6 cycles with first line chemotherapy with
antifolate/cisplatin (as determined by CT scanning)
- Measurable disease on CT scanning, by modified RECIST criteria or RECIST 1.1.
In absence of measurable disease a CT scan is needed to evaluate the disease.
- At least 18 years old
- WHO-ECOG performance status of 0 or 1

Exclusion Criteria

- any concurrent medical, psychological or psychiatric disease or condition
that is likely to interfere with study procedures or results, or that in the
opinion of the investigator would constitute a hazard for participating in this
study
- serious intercurrent chronic or acute illness such as cardiac or hepatic
disease considered by the investigator to constitute an unwarranted high risk
for investigational dendritic cell treatment
- known active acute or chronic infection, including human immunodeficiency
virus (HIV) and hepatitis B or C
-history of autoimmune disease
-subjects with an organ allograft

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the overall survival. Overall survival<br /><br>will be determined as the time from randomization until death. For subjects<br /><br>who are alive at the end of the study or lost to follow-up, OS will be censored<br /><br>on the last date when subjects are known to be alive.</p><br>

Secondary Outcome Measures