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Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03991975
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Dose limiting toxicity (DLT) [ Time Frame: up to 21 days ]
    Maximum tolerated dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of Anlotinib and TQB2450 in advanced acral malignant melanoma patients, Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21).
  • Maximum tolerated dose (MTD) [ Time Frame: up to 21 days ]
    MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)
  • Recommended Phase II dose (RP2D) [ Time Frame: up to 24 months ]
    The RP2D defined as the lower dose level to MTD based on the safety profile
  • Overall response rate (ORR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR)
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Dose limiting toxicity (DLT) [ Time Frame: up to 21 days ]
    Maximum tolerated dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of Anlotinib and TQB2450 in advanced acral malignant melanoma patients
  • Maximum tolerated dose (MTD) [ Time Frame: up to 21 days ]
    MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)
  • Recommended Phase II dose (RP2D) [ Time Frame: up to 24 months ]
    The RP2D defined as the lower dose level to MTD based on the safety profile
  • Overall response rate (ORR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Disease control rate(DCR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
  • Progression-free survival (PFS) [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause
  • Overall survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive
  • Adverse Event [ Time Frame: up to 24 months ]
    Number of participants with adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Disease control rate(DCR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
  • Progression-free survival (PFS) [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause
  • Overall survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive
  • Adverse Event: Drug dose adjustment [ Time Frame: up to 24 months ]
    Security Index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma
Official Title  ICMJE Phase Ib Study to Evaluate the Safety and Efficacy of TQB2450 (PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma
Brief Summary TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Acral Malignant Melanoma
Intervention  ICMJE
  • Drug: Anlotinib
    a multi-target receptor tyrosine kinase inhibitor.
  • Drug: TQB2450
    TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Study Arms  ICMJE Experimental: Anlotinib + TQB2450
TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Interventions:
  • Drug: Anlotinib
  • Drug: TQB2450
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.

2. Histologically or cytologically confirmed advanced acral malignant melanoma. 3. At least one measurable lesion. 4. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.

5. Has received at least first-line treatment but appeared disease progression or intolerance.

6. The main organs function are normally, the following criteria are met:

  1. hemoglobin ≥ 90 g/L; neutrophils ≥ 1.5*10^9/L; platelets ≥ 100 x 10^9/ L;
  2. total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN ; serum creatinine ≤1╳ULN,creatinine clearance >50 umol/L ;
  3. INR, aPTT, PT≤1.5 x ULN;
  4. left ventricular ejection fraction (LVEF) ≥50%. 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

8.Understood and signed an informed consent form.

Exclusion Criteria:

  1. Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  2. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
  3. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
  4. Has any active autoimmune disease or history of autoimmune disease.
  5. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.
  6. Has multiple factors affecting oral medication.
  7. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  8. Has any bleeding or bleeding events ≥ grade 3 or with unhealed wounds, ulcerative , or fractures within 4 weeks prior to the first administration.
  9. Has uncontrollable symptoms of brain metastasis, spinal cord compression, cancerous meningitis during screening within 8 weeks before first dose.
  10. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
  11. Has any serious and / or uncontrolled disease.
  12. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first dose.
  13. Has received granulocyte colony stimulating factor(G -CSF),or Granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to first dose.
  14. According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Guo, Doctor 010-88196341 guoj307@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991975
Other Study ID Numbers  ICMJE TQB2450-Ib-09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor  ICMJE Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP