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Mucosal MelanomaPhase 2NCT03602547

Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma.

A Phase 2 study testing CM082 plus JS001 in people with Mucosal Melanoma, run by AnewPharma 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study was a one-arm, single-center, phase II clinical study. Patients who meet the enrollment criteria will receive CM082 tablets 200mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days a treatment cycle until the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mucosal Melanoma
What is being tested?
CM082 plus JS001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
31 Jul 2018to Jun 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of recurrence after surgery, inoperable resection or metastasis advanced mucinous melanoma (III/IV period).
  • Has not received any systemic anti-tumor medication (previously adjuvant or neoadjuvant therapy is required, but the treatment should be completed for at least 4 weeks prior to the first dose of study drug, and all related toxicity events have returned to normal or no more than Grade I of CTCAE 4.03, except for hair loss).
  • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • All patients should provid tumor tissue specimens (preferably fresh tissue specimens) for PD-L1 expression analysis prior to enrollment.
  • There is at least one measurable lesion according to the RECIST 1.1 standard and the lesion has not received radiotherapy.
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  • Patients may have a history of brain/mesis metastases, but must undergo topical treatment(surgery/radiotherapy) and be clinically stable for at least 3 months prior to the start of the study .If orticosteroids have been used before, they should be discontinued for at least 2 weeks before the first dose of study drug.
  • The level of organ function must meet the following requirements (7 days before the first dose of study drug):
  • Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelet (PLT) ≥ 100 × 109 / L, hemoglobin (HB) ≥ 9g / dL (no blood transfusion or receiving blood components within 14 days before detection);
  • Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal（ULN）, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5*ULN (if liver metastasis, AST, ALT allowed) ≤ 5 *ULN);
  • Serum creatinine ≤ 1.5*ULN and endogenous creatinine clearance ≥ 50mL / min (Cockcroft-Gault formula);
  • Well-controlled hypertensive patients can be enrolled;
  • International normalized ratio (INR), activated partial thromboplastin time (aPTT) ≤ 1.5 *ULN for patients who have not received anticoagulant therapy; patients who receive anticoagulant therapy should be treated within the requirements of label
  • Urine protein ≤ 1+, if urine protein > 1+, 24 hours urine protein measurement is required, the total amount of which needs ≤ 1 gram;
  • FT3, FT4, TSH normal or abnormal has no clinical significance;
  • The heart function is normal, that is, the electrocardiogram is normal or abnormal has no clinical significance. The echocardiography shows that the left ventricular ejection fraction (LVEF) is greater than 50%.
  • Serum pregnancy test results must be negative within 7 days prior to the first dose of the test drug for women of childbearing age; males with fertility or women who are at risk of pregnancy must use highly effective methods of contraception throughout the trial (eg oral contraceptives, pIntrauterine device, controlled libido or barrier contraceptive method combined with spermicide), and continued contraception for 12 months after the end of treatment.
  • Ability to understand the nature of this trial and give written informed consent.Willingness and ability to comply with trial and follow-up procedures

Who cannot join

  • Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, or VEGFR TKI therapy.
  • Patients currently receiving anti-tumor treatment
  • Patients who participated in or were participating in other drug/therapy clinical trials within 4 weeks prior to the first dose of the study drug.
  • Patients who received large surgery within 4 weeks before the first dose of the test drug or has not recovered from the side effects of this operation, received live vaccination or immunotherapy within 4 weeks before the first dose of the test drug, and radiotherapy was performed within 2 weeks.
  • In the past 5 years, there have been history of malignant tumors other than mucosal melanoma, except for cured skin basal cell carcinoma, cutaneous squamous cell carcinoma, early prostate cancer, and cervical carcinoma in situ.
  • Hematopoietic stimulating factors were received within 1 week prior to the first dose of the study drug, such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin.
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  • HIV antibody or Treponema pallidum antibody test results are positive.
  • If HBsAg or HBcAb is positive, HBV DNA should be tested.Patients should be excluded if the measurement is above the upper limit of the normal range.If HCV antibody is positive, HCV DNA should be tested.Patients should be excluded if the measurement is above the upper limit of the normal range.
  • Those known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those known to be allergic to CM-082 and any of its excipients.
  • A large amount of pleural or ascites with clinical symptoms and requiring symptomatic treatment.
  • Active lung disease (eg, interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
  • Have any clinical problems out of control, including but not limited to:
  • Persistent or active (severe) infection;
  • Hypertension that is not effectively controlled (blood pressure lasts greater than 150/90mmHg);
  • Diabetes that is not effectively controlled;
  • Heart disease, defined as grade III/IV congestive heart failure or heart block defined by the New York Heart Association
  • Having a history of or suspected of having an autoimmune disease;Having a history of any kind of disease requiring treatment with a steroid/immunosuppressive, such as: pituitary inflammation, colitis, hepatitis, nephritis, hyperthyroidism, Hypothyroidism, etc.;
  • The following situation occurred within 6 months before the first dose:
  • Deep vein thrombosis or pulmonary embolism;
  • myocardial infarction;
  • severe or unstable arrhythmia or angina;
  • percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting;
  • Cerebrovascular accident, transient ischemic attack, and cerebral embolism.
  • The patient has any condition that affects the swallowing of the drug, as well as any conditions that affect the course of treatment (absorption, distribution, metabolism, or excretion) of the test drug, including any type of gastrointestinal resection or surgical history.
  • Have received a stem cell transplant or an organ transplant.
  • Has a history of psychotropic substance abuse which is unable to quit or has a history of mental disorders.
  • Patients who need to use during the study or have used or the following drugs within 14 days prior to the first dose: CYP3A4 strong inhibitor or strong inducer; warfarin or any other coumarin derivative anticoagulant.
  • The investigator judges other severe, acute or chronic medical illness or laboratory abnormalities that may increase the risk associated with the study or may interfere with the interpretation of the findings.
  • The investigator judged that the patient's compliance was poor or that there were other conditions that were not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

Jun Guo, M.D contact

010-88196951

guoj307@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, M.D, 010-88196951, guoj307@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Study of CM082 Combined With JS001 in the Treatment of Advanced Mucosal Melanoma.

This study was a one-arm, single-center, phase II clinical study. Patients who meet the enrollment criteria will receive CM082 tablets 200mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days a treatment cycle until the disease progresses , the toxicity is intolerable, the investigator or subject decides to withdraw, loses to follow up, starts using other anti-tumor treatments or dies.

Being tested
CM082 plus JS001

What participants receive

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

  • CM082 plus JS001Drug

    CM082：200mg once a day (qd) orally (taken within half an hour after breakfast). JS001 :An intravenous infusion of a solution having a concentration of 1-10 mg/ml was prepared with 0.9% physiological saline, and administered once every two weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.

Study groups in NCT03602547
Study groupRoleWhat they receive
CM082 plus JS001ExperimentalPatients who meet the enrollment criteria will receive CM082 tablets 200mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days A treatment cycle until the disease progresses, the toxicity is intolerable, the investigator or subject decides to withdraw, loses to follow up, starts using other anti-tumor treatments or dies.
Receives: Drug: CM082 plus JS001

What is being measured

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

  1. Objective Response Rate

    The proportion of patients with complete remission (CR) and partial remission (PR) in all patients.Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1.

    Measured: 12 months

Secondary outcomes (5)

  1. Disease Control Rate

    The proportion of patients with complete remission (CR),partial remission (PR) and stable diseasein(SD) all patients.Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

    Measured: 12 months

  2. Duration of Response

    The time interval between the first time of being evaluated as complete response (CR) or partial response (PR) and the first time of being evaluated as progressed disease(PD).Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

    Measured: 12 months

  3. Time to Response

    Time from randomization to complete response (CR) or partial response (PR).Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

    Measured: 12 months

  4. Progression-free survival

    The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death

    Measured: 12 months

  5. Overall survival

    The internal between the date of randomization and the date of death

    Measured: 36 months

Timeline

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

  1. First posted27 Jul 2018
  2. Study start31 Jul 2018
  3. Primary completionJul 2019 (estimated)
  4. Study completionJun 2020 (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
NCT03602547
Sponsor's protocol ID
CM082-CA-II-202
Status last verified
Jul 2019
First submitted
19 Jul 2018
Last updated
5 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CM082 plus JS001 in people with Mucosal Melanoma, run by AnewPharma 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 18 inclusion and 29 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 5 Jul 2019. 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 Jun Guo, M.D (010-88196951, 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 (time frame: 12 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 NCT03602547.

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 5 Jul 2019.

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