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

NCT03917069 | Unknown Phase 2

• 1 other identifier: 2019NPCE
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Melanoma

Keywords

nab-paclitaxel; carboplatin; endostatin; melanoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  The time from treatment to tumor progression or death

  3 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  At the end of Cycle 2 (each cycle is 28 days)

• Disease Control Rate (DCR)

  At the end of Cycle 2 (each cycle is 28 days)

• overall survival (OS)

  3 years

• Adverse events (AE)

  3 years

Study Arms (2)

nab-paclitaxel + endostatin+ carboplatin

EXPERIMENTAL

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

Drug: Chemotherapeutic Combinations

paclitaxel+carboplatin

ACTIVE COMPARATOR

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

Drug: chemotherapy

Interventions

Chemotherapeutic Combinations DRUG

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

nab-paclitaxel + endostatin+ carboplatin

chemotherapy DRUG

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

paclitaxel+carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jun Guo, Dr.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Mao, Dr.

CONTACT

861013261859885; yunzhongmanbu7848@163.com

Lu Si, Dr.

CONTACT

861088196956

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Beijing Cancer Hospital，Head of renal carcinoma & melanoma dept.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: March 23, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: data access requests will be reviewed by an external Independent Review Panel.Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)