Study of Iparomlimab and Tuvonralimab Plus Chemotherapy in Malignant Mesothelioma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Cancer Center, China
About this trial
This clinical trial aims to investigate the effectiveness and safety of a new treatment combination-Iparomlimab and Tuvonralimab (QL1706, a dual-function antibody targeting PD-1 and CTLA-4) combined with chemotherapy-for patients with malignant mesothelioma (MM). MM is a rare and aggressive cancer often linked to asbestos exposure. Current treatments have limited success, and this study seeks to explore a potentially more effective and safer option.
Study Design:
Phase Ib (Safety Phase): 6 patients will receive the combination therapy to assess safety. If no major safety issues arise, the study will proceed to Phase II.
Phase II (Efficacy Phase): 49 patients will be enrolled to evaluate treatment effectiveness. The study includes two groups for first-line treatment and second-line treatment.
Eligibility criteria
Qualifiers
Subjects must provide informed consent prior to initiating any study-specific procedures.
Male or female subjects aged ≥18 and ≤75 years.
Histologically/cytologically confirmed malignant mesothelioma (MM), including malignant pleural mesothelioma (PM) and malignant peritoneal mesothelioma (PeM).
Subjects with MM unsuitable for radical resection and/or radiotherapy per AJCC 8th Edition.
Disqualifiers
Prior CTLA-4 inhibitors prohibited; prior PD-1/PD-L1 allowed unless discontinued for immune toxicity
Immunomodulators within 14 days (e.g., thymosin, interleukin-2, interferon)
Significant cardiovascular history within 6 months
Trial design
Treatments tested in this trial
- iparomlimab and tuvonralimab (Dual PD-1/CTLA-4 blockade) + chemotherapy
Treatment groups
55 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
National Cancer Center, China
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator
Affiliated Cancer Hospital of Zhengzhou University
Collaborator
Beijing Chest Hospital, Capital Medical University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Shaanxi Provincial Cancer Hospital
Collaborator
Source ClinicalTrials.gov