Advanced MelanomaPhase 2NCT03917069
Nab-PCE vs PC for MM After Failure of Anti-PD-1
A Phase 2 study testing Chemotherapeutic Combinations and chemotherapy in people with Advanced Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Chemotherapeutic Combinations and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2019to 30 Sep 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, ≤ 70 years old, male or female;
- Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity);
- The patient has at least one (RECIST 1.1 standard) measurable lesion, which needs to be detected by spiral CT or MRI, and the tumor lesion has at least one single diameter ≥ 1 cm;
- ECOG PS is 0 or 1 (see Annex 1 for standards);
- The estimated survival period is ≥12 weeks;
- no chemotherapy contraindications, including normal peripheral blood, liver and kidney function and electrocardiogram are basically normal; Peripheral blood: neutrophils ≥1.5×109/L, platelets≥90×109/ L, hemoglobin≥90 g/L; Renal function: normal serum creatinine; For patients with non-metastatic liver function impairment: alanine, aspartate aminotransferase ≤ 2.5 ULN, For patients with metastatic liver dysfunction: alanine, aspartate aminotransferase ≤ 5 ULN;
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- Patients who have undergone topical treatment for asymptomatic brain metastases can be enrolled and have a clinical stable status of at least 4 weeks.
- Patients voluntarily participate in and sign an informed consent form.
- contraindications for the use of no carboplatin, paclitaxel, entropic and albumin paclitaxel
Who cannot join
- Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)
- Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment.
- Active infection requiring systemic therapy.
- A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence.
- Patients with a history or evidence of cardiovascular risk,
- History or evidence of interstitial lung disease or active non-infectious pneumonitis.
- Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.
- Pregnant or breastfeeding females, or expecting to conceive or father children within the projected period of study treatment (52 weeks followed by 4 months following end of study treatment).
Trial locations and contacts
1 site in 1 country.
Lu Si, Dr. contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lili Mao, Dr, 861013261859885, yunzhongmanbu7848@163.com
Lu Si, 861088196956
About this study
Official title: Nab-paclitaxel Plus Carboplatin Combined Endostatin Versus Solvent-based Paclitaxel Plus Carboplatin in the Treatment of Advanced Melanoma After the Failure of PD-1 Treatment #A Randomized Controlled, Open, Multicenter Trial
This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin
- Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin
- endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.
Read the detailed description
The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.
- Conditions
- Advanced Melanoma
- Being tested
- Chemotherapeutic Combinations, chemotherapy
- Keywords
- nab-paclitaxel, carboplatin, endostatin, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapeutic CombinationsDrug
nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d
chemotherapyDrug
paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel + endostatin+ carboplatin | Experimental | nab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d Receives: Drug: Chemotherapeutic Combinations |
| paclitaxel+carboplatin | Active comparator | paclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The time from treatment to tumor progression or death
Measured: 3 years
Secondary outcomes (4)
Objective response rate (ORR)
response evaluation disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) criteria.
response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases
Measured: At the end of Cycle 2 (each cycle is 28 days)
Disease Control Rate (DCR)
The disease control rate was the proportion of patients with complete remission, partial remission and stability (SD) in all patients.
Measured: At the end of Cycle 2 (each cycle is 28 days)
overall survival (OS)
OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data).
Measured: 3 years
Adverse events (AE)
Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start23 Mar 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun GUO, Peking University Cancer Hospital & Institute
- Investigators
- Jun Guo, Dr., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917069
- Sponsor's protocol ID
- 2019NPCE
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-paclitaxel Plus Carboplatin Combined Endostatin Versus Solvent-based Paclitaxel Plus Carboplatin in the Treatment of Advanced Melanoma After the Failure of PD-1 Treatment #A Randomized Controlled, Open, Multicenter Trial
- ClinicalTrials.gov ID
- NCT03917069
- Acronym / sponsor ID
- 2019NPCE
- Conditions
- Advanced Melanoma
- Keywords
- nab-paclitaxel, carboplatin, endostatin, melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin
- Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin
- endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.
Detailed description
The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel + endostatin+ carboplatin | Experimental | Drug: Chemotherapeutic Combinationsnab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d |
| paclitaxel+carboplatin | Active comparator | Drug: chemotherapypaclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old, ≤ 70 years old, male or female;
- Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity);
- The patient has at least one (RECIST 1.1 standard) measurable lesion, which needs to be detected by spiral CT or MRI, and the tumor lesion has at least one single diameter ≥ 1 cm;
- ECOG PS is 0 or 1 (see Annex 1 for standards);
- The estimated survival period is ≥12 weeks;
Key exclusion criteria (8 listed)
- Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)
- Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment.
- Active infection requiring systemic therapy.
- A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence.
- Patients with a history or evidence of cardiovascular risk,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapeutic Combinationsnab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d | Drug | nab-paclitaxel + endostatin+ carboplatin |
| chemotherapypaclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d | Drug | paclitaxel+carboplatin |
Primary outcome
Progression free survival (PFS)
Time frame: 3 years
The time from treatment to tumor progression or death
4 secondary outcomes
Objective response rate (ORR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Disease Control Rate (DCR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
overall survival (OS)
Time frame: 3 years
Adverse events (AE)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Advanced Melanoma
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A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Si, Dr. contact
Jun Guo, Dr. principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapeutic Combinations and chemotherapy in people with Advanced Melanoma, run by Peking University Cancer Hospital & Institute 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 9 inclusion and 8 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 17 Apr 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 Lili Mao, Dr. (861013261859885, yunzhongmanbu7848@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.