A Study of NKTR-214 Combined With Nivolumab vs Nivolumab alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma
- Conditions
- ntreated unresectable or metastatic melanomaMedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-001423-40-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 764
- Eastern Cooperative Oncology Group (ECOG) performance status of /= 80% (minors ages 12-17 only)
- Histologically confirmed stage III (unresectable) or stage IV melenoma
- Treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
- Active brain metastases or leptomeningeal metastases
- Uveal melanoma
- Participants with an active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether an investigational immunotherapy NKTR-214, when combined with nivolumab, is more effective than nivolumab by itself in participants with unresectable or metastatic melanoma that is previously untreated;Secondary Objective: - To evaluate efficacy of NKTR-214 combined<br>with nivolumab and that of nivolumab<br>monotherapy<br>- To evaluate the association between PD-L1<br>tumor expression on tumor cells (= 1% or < 1%/indeterminate) and efficacy measures<br>including PFS and ORR by BICR and OS.<br>-To evaluate the safety and tolerability of<br>NKTR-214 combined with nivolumab and<br>that of nivolumab monotherapy;Primary end point(s): - Overall response rate (ORR) by Blinded Independent central review (BICR) <br>- Progression-free survival (PFS) by BICR<br>- Overall survival (OS);Timepoint(s) of evaluation of this end point: 1- Approximately 16 months<br>2- Approximately 22 months <br>3- Up to 59 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Clinical Benefit Rate (CBR)<br>2- Duration of Response (DoR)<br>3- Time To Response (TTR)<br>4- ORR by investigator and in biomarker population<br>5- PFS by investigator and in biomarker population<br>6- OS in biomarker population<br>7- Incidence of participants with non-serious Adverse Events (AEs) 8- Incidence of participants with Serious Adverse Events (SAEs)<br>9- Incidence of treatment-related AEs<br>10- Incidence of treatment-related SAEs<br>11- Incidence of laboratory abnormalities in blood, blood serum and urine ;Timepoint(s) of evaluation of this end point: 1-4 Approximately 16 months<br>5 - Approximately 22 months <br>6 - Up to 59 months<br>7-11 Up to 5 years