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

AnewPharma1 site in 1 country40 target enrollmentJuly 31, 2018

ConditionsMucosal Melanoma

InterventionsCM082 plus JS001

DrugsCM082 plus JS001

Overview

Phase: Phase 2
Intervention: CM082 plus JS001
Conditions: Mucosal Melanoma
Sponsor: AnewPharma
Enrollment: 40
Locations: 1
Primary Endpoint: Objective Response Rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 31, 2018

End Date

June 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AnewPharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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);

Exclusion Criteria

•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.

Arms & Interventions

CM082 plus JS001

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.

Intervention: CM082 plus JS001

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 12 months

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.