Nab-PCE vs PC for MM After Failure of Anti-PD-1

NCT ID: NCT03917069

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-23
• Study Completion Date: 2022-09-30

Brief 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 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.

Conditions

Advanced Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel + endostatin+ carboplatin

nab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d

Group Type: EXPERIMENTAL

Chemotherapeutic Combinations

Intervention Type: DRUG

nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d

paclitaxel+carboplatin

paclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d

Group Type: ACTIVE_COMPARATOR

chemotherapy

Intervention Type: DRUG

paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d

Interventions

Chemotherapeutic Combinations

nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d

Intervention Type: DRUG

chemotherapy

paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old, ≤ 70 years old, male or female;

2. Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity);

3. 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;

4. ECOG PS is 0 or 1 (see Annex 1 for standards);

5. The estimated survival period is ≥12 weeks;

6. 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;

7. Patients who have undergone topical treatment for asymptomatic brain metastases can be enrolled and have a clinical stable status of at least 4 weeks.

8. Patients voluntarily participate in and sign an informed consent form.

9. contraindications for the use of no carboplatin, paclitaxel, entropic and albumin paclitaxel

Exclusion Criteria

1. Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)

2. Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment.

3. Active infection requiring systemic therapy.

4. 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.

5. Patients with a history or evidence of cardiovascular risk,

6. History or evidence of interstitial lung disease or active non-infectious pneumonitis.

7. Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.

8. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Jun GUO

Vice President of Beijing Cancer Hospital，Head of renal carcinoma & melanoma dept.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Guo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lili Mao, Dr.

Role: CONTACT

yunzhongmanbu7848@163.com

861013261859885

Lu Si, Dr.

Role: CONTACT

861088196956

Facility Contacts

Lili Mao, Dr

Role: primary

yunzhongmanbu7848@163.com

861013261859885

Lu Si

Role: backup

861088196956

Other Identifiers

2019NPCE

Identifier Type: -

Identifier Source: org_study_id