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Advanced MelanomaPhase 2NCT05466474

PD-1 Antibody Tislelizumab Combined With Dacarbazine in the Treatment of Advanced Melanoma

A Phase 2 study testing Tislelizumab Injection in people with Advanced Melanoma, run by Henan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A total of 40 subjects who had not received systemic treatment or chemotherapy in the past and were allowed to receive adjuvant or neoadjuvant treatment for advanced melanoma received tirelizumab combined with dacarbazine for 4-6 cycles to evaluate the efficacy, safety and prognosis of tirelizumab combined with… Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Advanced Melanoma
What is being tested?
Tislelizumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 Dec 2022to 30 Apr 2024
Phase
Phase 2
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 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 18-72 years (inclusive);
  • patients with unresectable stage III or IV melanoma diagnosed histologically or cytologically;
  • According to the efficacy evaluation criteria for solid tumors (RECIST V1.1), there are lesions that can be used as target lesions for evaluation;
  • Prior adjuvant or neoadjuvant therapy must have been completed for at least 4 weeks prior to study drug administration, and all associated toxic effects (except hair loss) have been recovered (to ≤ class 1 or baseline) prior to study drug administration;
  • ECOG score was 0-1;
  • The expected survival time is more than 3 months;
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  • No major surgery (except for baseline tumor biopsy) or severe trauma occurred at least 14 days prior to the first administration of study therapy;
  • Adequate organ and bone marrow function, as defined below:
  • Blood routine (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109 /L); Platelet count (PLT) ≥ 100,000/mm3 (100 × 109 /L); Hemoglobin (Hb) ≥ 9 g/dL (90 g/L); Blood biochemical Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance Rate (Cockroft-Gault formula) ≥ 60 mL /min; Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or ALT ≤2.5×ULN, Subjects with liver metastasis should be ≤5×ULN; Blood coagulation function International standardized ratio (INR) ≤1.5, prothrombin time (PT) and Activated partial thrombin time (APTT) ≤1.5×ULN; Routine urine urinary protein <2+; If urinary protein ≥2+, 24 hours of urinary protein quantitative significant Protein must be ≤1g; Thyroid function Thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, FT3(T3) should be investigated.
  • And FT4(T4), and normal FT3(T3) and FT4(T4) levels could be selected;
  • Female subjects of reproductive age must have performed a serological pregnancy test within 7 days prior to medication, with negative results, and be willing to use a medically approved highly effective contraceptive method (e.g., an intrauterine device, birth control pill, or condom) during the study period and for 3 months after the last medication; For male subjects with a female partner of reproductive age, surgical sterilization or consent was required during and after the study
  • Able to understand and voluntarily sign written informed consent;
  • Subjects must be willing and able to complete study procedures and follow-up examinations.

Who cannot join

  • Prior treatment with anti-PD-1, anti-PD-L1, and anti-PD-L2;
  • Previous treatment with dacarbazine
  • Received any other study treatment within 4 weeks prior to C1D1;
  • Surgical treatment and/or radiation therapy for melanoma are planned during the study period.
  • Imaging diagnosis showed the presence of central nervous system tumor lesions.
  • prior use of immunosuppressive drugs within 14 days prior to C1D1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10mg/ day of prednisone or other corticosteroids at pharmacologically equivalent doses).
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  • The presence or history of any active autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma that was in complete remission during childhood and did not currently require medical intervention could be included), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Severe infection (e.g., antibiotic, antifungal, or antiviral medication) within 4 weeks prior to C1D1, or unexplained fever >38.5°C during screening/prior to initial administration.
  • Significant clinical bleeding symptoms or clear bleeding tendency occurred within 3 months before C1D1, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation blood ++ or above, vasculitis, etc.; Or arteriovenous thrombosis events occurring within 6 months prior to C1D1, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; Or long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300mg/ day or clopidogrel ≥75mg/ day).
  • Active heart disease, including myocardial infarction, severe/unstable angina, etc., within 6 months before C1D1. Arrhythmias with poorly controlled left ventricular ejection fraction <50% on echocardiography (including QTcF interval >450ms in men and >470ms in women).
  • C1D1 has been diagnosed with any other malignancy within the previous 5 years, except for adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix.
  • known allergy to the study drug or any excipients thereof; Or severe allergic reactions to other monoclonal antibodies.
  • Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV-DNA ≥500IU/ mL), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of analysis method).
  • In the judgment of the investigator, there are concomitants (such as poorly controlled hypertension, severe diabetes, neurological or neurologic diseases, etc.) or any other conditions that seriously endanger the safety of the subjects, may confuse the results of the study, or may interfere with the completion of the study.

Trial locations and contacts

1 site in 1 country.

Wang Jiaqiang, Dr. contact

13592413731

wjqwtj@126.com

China1 site, 1 recruiting

  • Department of Bone and Soft Tissue ,Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Zhichao Tian, Dr., +8618737187831, tianzhichhaoyy@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Open-arm, Single-arm Phase II Trial of the PD-1 Antibody Tirelizumab Plus Dacarbazine as First-line Treatment for Advanced Melanoma

A total of 40 subjects who had not received systemic treatment or chemotherapy in the past and were allowed to receive adjuvant or neoadjuvant treatment for advanced melanoma received tirelizumab combined with dacarbazine for 4-6 cycles to evaluate the efficacy, safety and prognosis of tirelizumab combined with dacarbazine in the treatment of advanced melanoma.

Read the detailed description

In henan province tumor hospital into the group of 40 cases always will not accept any systemic therapy or chemotherapy, allowed to always have a recurrence of adjuvant or neoadjuvant therapy sensitive sensitive relapse (referring to more than six months after the last chemotherapy recurrence) of unresectable melanoma metastatic/operation subjects, accept for LeiLiZhu a joint resistance of kappa oxazine treatment 4-6 cycles, To evaluate the efficacy, safety and prognosis of tislelizumab combined with dacarbazine in the treatment of advanced melanoma.

Being tested
Tislelizumab Injection

What participants receive

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

  • Tislelizumab InjectionBiological

    Also called Dacarbazine

    Efficacy of tislelizumab or tislelizumab combined with dacarbazine in the treatment of advanced malignant melanoma.

Study groups in NCT05466474
Study groupRoleWhat they receive
Tislelizumab combined with dacarbazineExperimentalTislelizumab combined with dacarbazine in the treatment of advanced melanoma.
Receives: Biological: Tislelizumab Injection

What is being measured

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

  1. Objective response rate

    Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it

    Measured: Up to approximately 24months

  2. Progression-free survival

    From the start of treatment to the onset of disease progression or death of the patient

    Measured: Up to approximately 24months

Timeline

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

  1. First posted20 Jul 2022
  2. Study start30 Dec 2022
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466474
Sponsor's protocol ID
ZZUSC-13
Status last verified
Sep 2023
First submitted
17 Jul 2022
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab Injection in people with Advanced Melanoma, run by Henan Cancer Hospital 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 13 inclusion and 14 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 24 Oct 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.

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?

Results are not available in the source record.

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

Contact Wang Jiaqiang, Dr. (13592413731, wjqwtj@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 (time frame: Up to approximately 24months). The study lists 2 primary outcomes in all. 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 NCT05466474.

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 24 Oct 2023.

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