NCT03917069

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Chemotherapeutic Combinations	nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d
DRUG	chemotherapy	paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d

Timeline

• Start date: 2019-03-23
• Primary completion: 2021-09-30
• Completion: 2022-09-30
• First posted: 2019-04-16
• Last updated: 2019-04-17

Locations

1 site across 1 country: China