| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Acral Malignant Melanoma | Drug: Anlotinib Drug: TQB2450 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 42 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase Ib Study to Evaluate the Safety and Efficacy of TQB2450 (PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Acral Malignant Melanoma |
| Actual Study Start Date : | June 11, 2019 |
| Estimated Primary Completion Date : | March 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
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)
|
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.
|
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
8.Understood and signed an informed consent form.
Exclusion Criteria:
| Contact: Jun Guo, Doctor | 010-88196341 | guoj307@126.com |
| China, Beijing | |
| Beijing Cancer Hospital | Recruiting |
| Beijin, Beijing, China, 100083 | |
| Contact: Jun Guo, Doctor 010-88196341 guoj307@126.com | |
| 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 |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| 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 |
|
||||
| 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:
|
||||
| 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 |
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:
8.Understood and signed an informed consent form. Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| 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 |
|
||||
| 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 |
|||||