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Metastatic MelanomaPhase 3JS001NCT03430297

A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma

A Phase 3 study testing JS001 240mg Q2W and Dacarbazine 1000mg/m2 Q3W in people with Metastatic Melanoma and Unresectable Melanoma, run by Shanghai Junshi Bioscience Co., Ltd. at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is one phase III, randomized, open-label study in comparison of JS001 with dacarbazine as the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma. The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous melanoma and M stage (M0vsM1a/M1bvsM1c). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma, Unresectable Melanoma
What is being tested?
JS001 240mg Q2W and Dacarbazine 1000mg/m2 Q3W
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
11 sitesChina
Study dates
2 Feb 2018to 27 Nov 2023
Phase
Phase 3
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

  • Patients are eligible for participation in the trial only when they meet the following criteria:
  • Age ≥18 years, male or female;
  • Systemic treatment-naïve, histologically confirmed unresectable stage III or IV melanoma. Previous adjuvant or neoadjuvant therapy is allowed, however, it is required to be completed at least three weeks prior to the randomization, and all the relevant adverse events have been recovered to normal or CTC-AE grade 1;
  • Measurable lesion (according to RECIST v1.1 criteria);
  • ECOG score 0 or 1
  • Tumor tissue has to be provided (FFPE archival or newly acquired tissue block or unstained slide from FFPE) for analysis of biomarkers;
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  • Previous radiotherapy must be completed at least two weeks prior to administration of investigational product;
  • The laboratory data for screening must meet the following criteria and should be acquired within 14 days prior to the first dose:
  • Peripheral hemogram: white blood cell (WBC) ≥3.0×109/L, neutrophil (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hgb) ≥90g/L;
  • Renal function: serum creatinine°≤1.5 x ULN or calculated creatinine clearance (CrCl) >40 mL/min (using Cockcroft Gault formula);
  • Hepatic function: AST/ALT≤2.5 x ULN in subjects without hepatic metastasis, AST/ALT≤5 x ULN in those with hepatic metastasis;
  • Total bilirubin ≤1.5 x ULN (except the subjects with Gilbert syndrome, the total bilirubin must be < 3.0mg/dL).
  • Estimated survival ≥16 weeks;
  • Men with reproductive capacity or women of childbearing potential must use highly effective contraceptive methods during the trial (e.g., oral contraceptives, intrauterine device, sexual abstinence or barrier method combined with spermicide), and continue contraception for 12 months after the end of treatment;
  • Subject is willing to participate in the study, sign the informed consent form with good compliance and cooperation with follow-up;
  • Re-enrollment: re-enrollment of subjects who discontinue the study for failure prior to the treatment (i.e., the subject has not been randomized/received any treatment yet) is allowed in this study. The subjects must re-sign the informed consent form if they are re-enrolled.

Who cannot join

  • Patients will be excluded from the trial when they have any one of the following conditions:
  • Previous treatment with anti-PD-1, anti-PD-L1or anti-PD-L2 therapy;
  • Known allergy to recombinant humanized anti-PD-1 monoclonal antibody and its components;
  • Presence of BRAF mutation, except unwillingness or inability to receive BRAF mutation inhibitor;
  • Malignant melanoma originated from eyes or mucosa;
  • Having received other anti-tumor therapy (including corticosteroids, immunotherapy) or participated in other clinical studies within 4 weeks prior to the start of treatment, or having not recovered from the previous toxicity (except grade 2 alopecia and grade 1 neurotoxicity);
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  • Pregnant or lactating women;
  • HIV positive; HCV positive; positive HBV DNA copies detected simultaneously with HBsAg or HBCAb positive (quantitative detection limit 500 IU/ml);
  • History of active pulmonary tuberculosis;
  • Active autoimmune disease requiring systemic treatment in the past two years (e.g., use of disease-modulating drugs, corticosteroids or immunosuppressive drugs), relevant alternative therapy is allowed (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency);
  • Other serious, uncontrollable concomitant diseases that may affect the compliance with protocol or interfere with interpretation of the results, including active opportunistic infection (serious) infection in progressive stage, uncontrollable diabetes, cardiovascular disease (grade Ⅲ or Ⅳ heart failure defined by New York Heart Association, degree Ⅱ and above cardiac block, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm);
  • Subjects with active central nervous system (CNS) metastasis, active brain metastasis or leptomeningeal metastatic foci. For the subjects with brain metastasis, if they have received treatment and have no evidence of progressive disease on the nuclear magnetic resonance imaging (MRI) at least 8 weeks after completion of the treatment and within 28 days prior to the first dose, they are eligible to participate in the study. Meanwhile, it is required corticosteroid for systemic therapy at the dose of immunosuppressant (>10mg/day prednisone equivalent) must not be needed at least two weeks prior to administration of investigational product;
  • Previously receiving hematopoietic stimulating factor within two weeks prior to the start of treatment, for example, colony stimulating factor, erythropoietin;
  • Having been injected by live vaccine within 4 weeks prior to the start of treatment;
  • Major surgery within 4 weeks prior to the start of treatment (not including diagnostic surgery);
  • History of psychotropic drug abuse and inability to give up or history of mental disorder;
  • Having other malignant tumors that have not been recovered in the past 5 years, not including obviously cured malignancies, or curable cancers, for example, basal cell carcinoma or squamous cell cutaneous carcinoma, superficial bladder cancer or carcinoma in situ of prostate, carcinoma in situ of cervix or carcinoma in situ of breast;
  • Other severe, acute or chronic medical or mental diseases or abnormal laboratory findings that may increase the risk from participation in the study, or interfere with interpretation of study results according to investigators' opinion.
  • Eligibility criteria on cross-over to JS001 treatment period -inclusion criteria for the subjects who are previously randomized into DTIC:
  • According to investigators' evaluation, the subjects must have documented radiological progression of disease during DTIC treatment;
  • Previous anticancer therapy, including DTIC and palliative radiotherapy, must be completed at least three weeks prior to the dose of JS001;
  • Adverse events related with DTIC or palliative radiotherapy must have been relieved to grade 1 or baseline at randomization;
  • Any major surgery must be completed at least 28 days prior to the first dose of JS001;
  • No previous treatment with anti-PD-1 or anti-PD-L1 therapy;
  • The laboratory data on the eligibility for cross-over therapy must meet the following criteria and should be acquired within 14 days prior to the start of JS001 treatment:
  • Peripheral hemogram: white blood cell (WBC) ≥3.0×109/L, neutrophil (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hgb) ≥90g/L;
  • Renal function: serum creatinine≤1.5 x ULN or calculated creatinine clearance (CrCl) >40 mL/min (using Cockcroft Gault formula);
  • Hepatic function: AST/ALT≤2.5 x ULN in subjects with no hepatic metastasis, AST/ALT≤5 x ULN in those with hepatic metastasis;
  • Total bilirubin≤1.5 x ULN (except the subjects with Gilbert syndrome, total bilirubin must be<3.0mg/dL).
  • Men with reproductive capacity or women of childbearing potential must use highly effective contraceptive methods during the trial (e.g., oral contraceptives, intrauterine device, sexual abstinence or barrier method combined with spermicide), and continue contraception for 12 months after the end of treatment;
  • Subjects are willing to participate in the study, sign the informed consent form with good compliance and cooperation with follow-up;

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Hospital Of Jilin University

    Changchun, Jilin, 130061

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Hefei Binhu Hospital

    Hefei, Anhui, 230092

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Wuhan Union Hospital

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

This is one phase III, randomized, open-label study in comparison of JS001 with dacarbazine as the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma. The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous melanoma and M stage (M0vsM1a/M1bvsM1c). Using standard dose and dose interval, the subjects will be given JS001 240mg intravenously, once every two weeks, or dacarbazine 1000mg/m2, d1, intravenously, once every three weeks. One cycle of therapy is 6 weeks (3 doses of JS001 or 2 doses of dacarbazine per cycle).

Read the detailed description
  1. In the subjects who have clinical benefit evaluated by investigators and tolerate the study treatment, treatment will be considered to give after occurrence of progression defined by RECIST1.1 as evaluated by the initial investigators, these subjects must terminate the treatment when further progression is validated.
  2. The subjects in dacarbazine treatment group are allowed to be crossed to receive JS001 after progression of disease; however, they need to be re-evaluated if they meet the inclusion/exclusion criteria.

Subjects need to provide one tumor tissue specimen for archival or one newly acquired biopsy tissue from the site that is previously not irradiated for evaluation of PD-L1 expression status when they participate in the study. The PD-L1 expression status of specimen will be evaluated in the central laboratory using immunohistochemical (IHC) method. Subjects with positive or negative PD-L1 can be enrolled in this study, and the clinical activity in the two subgroups will be evaluated in accordance with the prespecified subgroup analysis.

Being tested
JS001 240mg Q2W, Dacarbazine 1000mg/m2 Q3W
Keywords
anti-PD-1 monoclonal antibody, the First Line Therapy, Dacarbazine, Melanoma
Medical subject headings
Melanoma

What participants receive

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

  • JS001 240mg Q2WBiological

    recombinant humanized anti-PD-1 monoclonal antibody injection (JS001) will be provided by the sponsor. Strength: 240mg/6ml/vial. 240mg, once every two weeks.

    Control drug: dacarbazine (1000mg/m2, d1, intravenously, once every three weeks). The dose will be given intravenously over 180 minutes (the infusion time can be prolonged according to the institutional criteria), starting from Week 1, once every 3 weeks, until progression of disease.

  • Dacarbazine 1000mg/m2 Q3WDrug

    The dose of DTIC will be calculated according to the following formula, where the 'X' represents the total mg dose of DTIC: X (mg) = [body surface area (BSA) x (1000mg/m2)].

    The body surface area (BSA) is defined by Dubois formula: BSA (m2) = 0.007184* (cm0.725) * (kg0.425)

Study groups in NCT03430297
Study groupRoleWhat they receive
JS001 240mg Q2WExperimentalNot described
Receives: Biological: JS001 240mg Q2W
Dacarbazine 1000mg/m2 Q3WActive comparatorNot described
Receives: Drug: Dacarbazine 1000mg/m2 Q3W

What is being measured

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

  1. the progression-free survival (PFS)

    To compare the progression-free survival (PFS) evaluated by one independent review board of radiological data in systemic treatment-naïve patients with unresectable, locally advanced or metastatic melanoma who are treated with JS001 versus dacarbazine.

    Measured: 3 months

Secondary outcomes (3)

  1. objective response rate (ORR)

    To compare objective response rate (ORR) evaluated by the independent review board of radiological data according to RECIST 1.1 between the two groups;

    Measured: 2 years

  2. duration of response (DOR)

    To compare duration of response (DOR) evaluated by the independent review board of radiological data according to RECIST 1.1 between the two groups;

    Measured: 2 years

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 2 years

Timeline

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

  1. First posted12 Feb 2018
  2. Study start2 Feb 2018
  3. Primary completion12 Jul 2023
  4. Study completion27 Nov 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430297
Sponsor's protocol ID
HMO-JS001-III-MM-01
Acronym
JS001
Status last verified
Sep 2024
First submitted
29 Jan 2018
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheng X, Huang G, Fang M, Li K, Wu D, Zhang X, Chen J, Zhu D, Chen Y, Li H, Gao Q, Wu L, Tang B, Yan X, Zeng R, Li J, Yu W, Xu J, Hao Y, Jin C, Zou J, Guo J. Toripalimab vs Dacarbazine as First-Line Therapy for Advanced Melanoma of Acral Subtype: The Phase 3 MELATORCH Randomized Clinical Trial. JAMA Oncol. 2026 Mar 1;12(3):243-250. doi: 10.1001/jamaoncol.2025.5751.

    PubMed 41481311

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JS001 240mg Q2W and Dacarbazine 1000mg/m2 Q3W in people with Metastatic Melanoma and Unresectable Melanoma, run by Shanghai Junshi Bioscience Co., Ltd. at 11 sites 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 16 inclusion and 31 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the progression-free survival (PFS) (time frame: 3 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 NCT03430297, which also lists 1 linked publication.

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 19 Sep 2024.

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