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MelanomaNCT05478473

Clinical Study of Chidamide Combined With Toripalimab in the Treatment of Advanced Melanoma

A study testing Chidamide combined with Toripalimab in people with Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study was a single-arm study designed to evaluate the efficacy and safety of Chidamide combined with Toripalimab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Chidamide combined with Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
27 Oct 2022to Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • aged ≥ 18 years, male or female
  • histologically and/or cytologically confirmed melanoma, clinically diagnosed as inoperable stage III-IV
  • previous treatment for advanced tumors (including chemotherapy, targeted, anti-vascular drugs, etc.) failure or no standard treatment, and no PD- (L) 1/CTLA-4 drug treatment; if neoadjuvant/adjuvant therapy has received PD- (L) 1/CTLA-4 drug treatment, the total duration of drug treatment should be ≥6 months
  • if there is brain metastasis, local treatment must have been received before participating in this study and clinical stability ≥ 3 months
  • ECOG score 0-1
  • at least one measurable lesion (according to RECISTv1.1 evaluation criteria)
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  • absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L
  • other organ function needs to meet: ① cardiac function needs to meet: left ventricular ejection fraction ≥ 50%, no organic arrhythmia; ② liver function needs to meet: ALT and AST ≤ 2.5 times the upper limit of normal (such as with liver metastasis, ALT and AST ≤ 5 times the upper limit of normal), total bilirubin ≤ 1.5 times the upper limit of normal;③ renal function needs to meet: creatinine ≤ 1.5 times the upper limit of normal; ④ coagulation function: international normalized ratio (International Normalized Ratio,INR) ≤ 1.5 times upper limit of normal; prothrombin time (PT), activated partial thromboplastin time (APTT) ≤ 1.5 times upper limit of normal (unless the subject was receiving anticoagulant therapy and PT and APTT were within the expected range of anticoagulant therapy at screening); ⑤ Thyroid function: thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within ± 10% of normal values.
  • Expected survival time ≥ 3 months
  • Voluntarily participate in this clinical trial and sign a written informed consent.
  • Previous anti-tumor therapy (chemotherapy, radiotherapy, targeting, traditional Chinese medicine, other immunotherapy) requires eluting for 28 days.
  • The adverse effects of previous antitumor therapy were resolved to grade 0-1 before the screening period (as determined by NCI CTCAE 5.0; Except for toxicity, such as hair loss, which the investigator determined did not pose a safety risk to the subject)

Who cannot join

  • no measurable lesions, such as pleural or pericardial exudates, ascites, etc.
  • choroidal melanoma
  • previous treatment with HDAC inhibitors (including cedaramide, romidepsin, vorinostat, bellistat, panobinostat, etc.)
  • history of interstitial lung disease or pneumonia requiring oral or intravenous steroids
  • previous vaccination or planned vaccination with live vaccines (seasonal influenza vaccine without live vaccines is allowed), major surgery within 30 days before the first study treatment
  • active infection [active bacterial, viral, fungal, mycobacterial, parasitic infections or other infections (excluding fungal infections of the nail bed) within 4 weeks before the screening period, or any major infection event requiring intravenous antibiotic therapy, or targeted antiviral therapy, or hospitalization; Active hepatitis is defined as HBsAg positive with HBV DNA≥500 IU/ml or HCV antibody positive with HCV copy number > the upper limit of normal], or persistent fever within 14 days before screening
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  • history of immunodeficiency, including positive HIV testing, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation
  • uncontrolled cardiovascular disease; history of clinically significant QT prolongation, or screening period > 470 ms for females and > 450 ms for males
  • positive baseline pregnancy test in female subjects who are pregnant or lactating or fertile females; or subjects of childbearing age who are unwilling to take effective contraceptive measures for at least 180 days during study participation and after the last dose of study drug
  • According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the subject' s safety or affect the subject 's completion of the study (e.g., severe hypertension ≥ 180/110 mmHg, uncontrolled diabetes, thyroid disease, Hypertriglyceridemia ≥ grade 2, etc.)
  • History of definite neurological or psychiatric disorders, including epilepsy or dementia
  • Any condition that, in the opinion of the investigator, would make participation in this study inappropriate.

Trial locations and contacts

1 site in 1 country.

Jun Guo, Doctor contact

861088196348

guoj307@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

Other trials in China

About this study

The study was a single-arm study designed to evaluate the efficacy and safety of Chidamide combined with Toripalimab.

Conditions
Melanoma
Being tested
Chidamide combined with Toripalimab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chidamide combined with ToripalimabDrug

    chidamide：oral, 30 mg/time, twice weekly; Toripalimab：intravenous drip, 240mg, once every 3 weeks

Study groups in NCT05478473
Study groupRoleWhat they receive
Chidamide combined with ToripalimabExperimentalNot described
Receives: Drug: Chidamide combined with Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Objective response rate (ORR)as measure of efficacy by RECIST 1.1

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Progression Free survival （PFS）

    Defined as the time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first)

    Measured: Up to approximately 24 months

  2. Overall Survival（OS）

    OS as measure of efficacy by RECIST 1.1

    Measured: Up to approximately 24 months

  3. Duration of Response(DoR)

    DoR as measure of efficacy by RECIST 1.1

    Measured: Up to approximately 24 months

  4. Disease control rate（DCR）

    Defined as the percentage of patients who have achieved a confirmed response of at least CR or PR or a response of SD

    Measured: Up to approximately 24 months

  5. Incidence Rate of each Toxicity (safety and tolerability)

    safety and tolerability as measure of efficacy by CTCAE 5.0

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start27 Oct 2022
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478473
Sponsor's protocol ID
CSIIT-Q31
Status last verified
Jun 2023
First submitted
27 Jul 2022
Last updated
18 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Chidamide combined with Toripalimab in people with Melanoma, run by Peking University Cancer Hospital & Institute 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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun Guo, Doctor (861088196348, guoj307@126.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: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478473.

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 18 Jun 2023.

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