Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal CancerPhase 2NCT06670300
Clinical Observation on the Safety and Efficacy of Cardonilmab in the Treatment of Second-line and Above Advanced Melanoma and Advanced Renal Cancer
A Phase 2 study testing cardonilimab in people with Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer, run by YongZhang at 1 site in China.
Trial summary
Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma. To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer
- What is being tested?
- cardonilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Dec 2027
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to sign informed consent;
- Age ≥18 years, ≤75 years;
- Cohort 1: histopathologically diagnosed metastatic mucosal or acro-type malignant melanoma with at least second-line prior treatment, including but not limited to PD-1 or PDL1 monoclonal antibody; Cohort 2: histopathologically confirmed metastatic renal cancer with at least second-line prior treatment.
- There is at least one radiologically measurable lesion according to RECIST1.1 efficacy evaluation criteria;
- ECOG physical strength score 0-2 points;
- Expected survival ≥3 months;
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- Major organ function meets the following criteria 7 days before treatment:
- Blood routine: neutrophil absolute value ≥1.5×109/L; Hemoglobin ≥80g/L; Platelet ≥90×109/L; B. Blood biochemistry: total bilirubin ≤1.5ULN; ALT and AST≤2.5ULN (Subjects with liver metastases allow ALT or AST≤5×ULN); Serum creatinine ≤1.5ULN or creatinine clearance ≥50ml/min; C. Left ventricular ejection fraction ≥50%; D. Activated partial thromboplastin time (APTT), International Normalized ratio (INR), prothrombin time (PT) ≤1.5ULN; E. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may be enrolled F. Myocardial enzyme profiles and troponin within the normal range (simple laboratory abnormalities that are not clinically significant are also allowed to be included)
- Women of reproductive age should use effective contraception during the study period and for 6 months after the end of the study; A negative serum or urine pregnancy test within 7 days prior to study enrollment; Non-lactating patients; Men should agree to use effective contraception during the study period and for 6 months after the end of the study period;
- Patients were able to follow the study plan and protocol requirements.
Who cannot join
- The presence of symptomatic or untreated known brain metastases or other CNS metastases. Central nervous system metastases that have been shown to be stable or improved after complete resection and/or radiotherapy are not an exclusion criterion, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, there is no evidence of cerebral edema and no need for corticosteroids or anticonvulsants;
- Uncontrolled active infections at the time of screening (such as sepsis, bacteremia, fungemia, viremia, etc.);
- Active viral hepatitis B or C: Hepatitis B (defined as the presence of hepatitis B core antibody [HBcAb] or hepatitis B surface antigen [HBsAg], and hepatitis B virus DNA [HBV-DNA]) > 1000cps/mL or > lower limit of quantification according to local laboratory methods); Or test positive for hepatitis C (hepatitis C antibodies and/or hepatitis C virus RNA ([RNA]);
- HIV-infected patients;
- The patient is known to have systemic vasculitis (e.g., Wegener granuloma, polyarteritis nodosa), systemic lupus erythematosus, co-active or uncontrolled autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe symptoms) Infectious diseases, etc.);
- The patient has a known history of other malignancies;
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- Those who are known to be allergic to the active ingredients or excipients of cardonilizumab in this study;
- Previously received anti-CTLA-4 specific antibody drug treatment;
- is currently participating in an interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
- Received systemic systemic treatment with proprietary Chinese medicines with anticancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
- Patients who had systematically used large amounts of glucocorticoids in the 4 weeks prior to enrollment (except those who used inhaled hormones);
- Serious mental disorders;
- Patients with serious heart, liver, renal insufficiency, diabetes and other diseases;
- Pregnant or lactating women;
- Medical history or evidence of disease that may interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The investigator considers other potential risks unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou
About this study
Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma.
To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma.
Primary end point: objective response rate (ORR) Secondary end point: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), incidence of treatment-related adverse events Exploratory study end point: efficacy related marker exploration, gut microbiota or metabolomics changes
- Conditions
- Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer
- Being tested
- cardonilimab
- Keywords
- melanoma, renal cancer, Cardonilizumab
- Medical subject headings
- Melanoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardonilimabDrug
Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study.
| Study group | Role | What they receive |
|---|---|---|
| cardonilimab for advanced melanoma | Experimental | Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study. Receives: Drug: cardonilimab |
| cardonilimab for advanced kidney cancer | Experimental | Subjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study. Receives: Drug: cardonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: From the date of randomization to the date of first documented progression up to 24 months
Secondary outcomes (3)
Progression Free Survival
Measured: From the date of randomization to the date of first documented progression up to 24 months
Overall Surviva
Measured: From the date of randomization to the date of death from any cause up to 36 months
Disease Control Rate
Measured: From the date of randomization to the date of first documented progression up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Melanoma and kidney cancer
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YongZhang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, YongZhang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670300
- Sponsor's protocol ID
- 2024-011
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 1 Nov 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation on the Safety and Efficacy of Cardonilmab in the Treatment of Second-line and Above Advanced Melanoma and Advanced Renal Cancer
- ClinicalTrials.gov ID
- NCT06670300
- Acronym / sponsor ID
- 2024-011
- Conditions
- Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer
- Keywords
- melanoma, renal cancer, Cardonilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- YongZhangOther government
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Nov 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.
Safety and efficacy of Cardonilmab as a second-line or above treatment in patients with advanced malignant melanoma and renal cell carcinoma.
To investigate the safety and efficacy of cardunnilizumab in the treatment of advanced mucosal, acral and cutaneous malignant melanoma and advanced renal cell carcinoma.
Primary end point: objective response rate (ORR) Secondary end point: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), incidence of treatment-related adverse events Exploratory study end point: efficacy related marker exploration, gut microbiota or metabolomics changes
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Melanoma and kidney cancer
| Arm | Type | Receives |
|---|---|---|
| cardonilimab for advanced melanoma | Experimental | Drug: cardonilimabSubjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study. |
| cardonilimab for advanced kidney cancer | Experimental | Drug: cardonilimabSubjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to sign informed consent;
- Age ≥18 years, ≤75 years;
- Cohort 1: histopathologically diagnosed metastatic mucosal or acro-type malignant melanoma with at least second-line prior treatment, including but not limited to PD-1 or PDL1 monoclonal antibody; Cohort 2: histopathologically confirmed metastatic renal cancer with at least second-line prior treatment.
- There is at least one radiologically measurable lesion according to RECIST1.1 efficacy evaluation criteria;
- ECOG physical strength score 0-2 points;
Key exclusion criteria (15 listed)
- The presence of symptomatic or untreated known brain metastases or other CNS metastases. Central nervous system metastases that have been shown to be stable or improved after complete resection and/or radiotherapy are not an exclusion criterion, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, there is no evidence of cerebral edema and no need for corticosteroids or anticonvulsants;
- Uncontrolled active infections at the time of screening (such as sepsis, bacteremia, fungemia, viremia, etc.);
- Active viral hepatitis B or C: Hepatitis B (defined as the presence of hepatitis B core antibody [HBcAb] or hepatitis B surface antigen [HBsAg], and hepatitis B virus DNA [HBV-DNA]) > 1000cps/mL or > lower limit of quantification according to local laboratory methods); Or test positive for hepatitis C (hepatitis C antibodies and/or hepatitis C virus RNA ([RNA]);
- HIV-infected patients;
- The patient is known to have systemic vasculitis (e.g., Wegener granuloma, polyarteritis nodosa), systemic lupus erythematosus, co-active or uncontrolled autoimmune disease (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe symptoms) Infectious diseases, etc.);
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 |
|---|---|---|
| cardonilimabSubjects will receive cardonilimab 10mg/kg once every three weeks; The maximum duration of administration is 2 years until disease progression or death, toxicity becomes intolerable, subject voluntarily requests withdrawal, or investigator determines that subject needs to withdraw from the study. | Drug | cardonilimab for advanced kidney cancer, cardonilimab for advanced melanoma |
Primary outcome
Objective Response Rate
Time frame: From the date of randomization to the date of first documented progression up to 24 months
3 secondary outcomes
Progression Free Survival
Time frame: From the date of randomization to the date of first documented progression up to 24 months
Overall Surviva
Time frame: From the date of randomization to the date of death from any cause up to 36 months
Disease Control Rate
Time frame: From the date of randomization to the date of first documented progression up to 24 months
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 1 Nov 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cardonilimab in people with Participants Who Had Received Second-line or Higher Advanced Melanoma and Advanced Renal Cancer, run by YongZhang at 1 site in China.
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 10 inclusion and 15 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yong Zhang, Dr (86-15838177190, zlyyzy2832@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From the date of randomization to the date of first documented progression up to 24 months). 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 1 Nov 2024.