Pleural MesotheliomaPhase 2NCT06416930
Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
A Phase 2 study testing Cadonilimab Combined with chemotherapy in people with Pleural Mesothelioma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma
- What is being tested?
- Cadonilimab Combined with chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2024to 20 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic pleural mesothelioma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
- Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
- Adequate haematological, renal and liver function.
Who cannot join
- Primary mesothelioma of peritoneum, pericardium and testes
- Active, untreated central nervous system (CNS) metastasis.
- Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
- Known active autoimmune diseases.
- Presence of other uncontrolled serious medical conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
- Conditions
- Pleural Mesothelioma
- Being tested
- Cadonilimab Combined with chemotherapy
- Keywords
- Cadonilimab, pleural mesothelioma, Bispecific Antibody
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab Combined with chemotherapyDrug
Also called AK104
Cadonilimab (15mg/kg, intravenous drip, D1) + gemcitabine (1250mg/m2, intravenous drip, D1/D8) or vinorelbine (30mg, oral, tiw, D1/D3/D5) or pemetrexed (500mg/m2, intravenous drip, D1), every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab combined with chemotherapy | Experimental | All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks. Receives: Drug: Cadonilimab Combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Measured: 2 year
Secondary outcomes (5)
Disease Control Rate (DCR)
defined as the percentage of participants who achieve a best overall response of complete response, partial response, or stable disease assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Measured: 2 year
Progression Free Survival (PFS)
defined as the time between the date of first dose of study drug and the date of first documented tumor progression per mRECIST v1.1, or death due to any cause, whichever occurs first.
Measured: 2 year
Duration of Response (DoR)
defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.
Measured: 2 year
Overall Survival (OS)
defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented tumor progression, or death due to any cause, whichever occurs first.
Measured: 2 year
Adverse Events (AEs)
Incidence and severity of adverse events (AE) and clinically significant abnormal laboratory results
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Akesobio
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416930
- Sponsor's protocol ID
- AK104-IIT-039
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT06416930
- Acronym / sponsor ID
- AK104-IIT-039
- Conditions
- Pleural Mesothelioma
- Keywords
- Cadonilimab, pleural mesothelioma, Bispecific Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Akesobio
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab combined with chemotherapy | Experimental | Drug: Cadonilimab Combined with chemotherapyAll subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed advanced or metastatic pleural mesothelioma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
- Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
- Adequate haematological, renal and liver function.
Key exclusion criteria (5 listed)
- Primary mesothelioma of peritoneum, pericardium and testes
- Active, untreated central nervous system (CNS) metastasis.
- Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
- Known active autoimmune diseases.
- Presence of other uncontrolled serious medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadonilimab Combined with chemotherapyAlso: AK104Cadonilimab (15mg/kg, intravenous drip, D1) + gemcitabine (1250mg/m2, intravenous drip, D1/D8) or vinorelbine (30mg, oral, tiw, D1/D3/D5) or pemetrexed (500mg/m2, intravenous drip, D1), every 3 weeks. | Drug | Cadonilimab combined with chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 year
defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: 2 year
Progression Free Survival (PFS)
Time frame: 2 year
Duration of Response (DoR)
Time frame: 2 year
Overall Survival (OS)
Time frame: 2 year
Adverse Events (AEs)
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab Combined with chemotherapy in people with Pleural Mesothelioma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang (13910704669, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.