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

NCT03602547 | Unknown Phase 2

• 1 other identifier: CM082-CA-II-202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mucosal Melanoma

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (5)

• Disease Control Rate

  12 months

• Duration of Response

  12 months

• Time to Response

  12 months

• Progression-free survival

  12 months

• Overall survival

  36 months

Study Arms (1)

CM082 plus JS001

EXPERIMENTAL

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.

Drug: CM082 plus JS001

Interventions

CM082 plus JS001 DRUG

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.

CM082 plus JS001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

vorolanib

Study Officials

• Jun Guo, M.D

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Jun Guo, M.D

CONTACT

010-88196951; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: July 31, 2018
• Primary Completion: July 1, 2019
• Study Completion: June 1, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CN (1)