A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
- Conditions
- melanomaskin cancer10040900
- Registration Number
- NL-OMON55514
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
- Male or female must be >= 18 years
- Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV
melanoma
- Previously treated for unresectable or metastatic melanoma. Subjects must
have at least received the following treatments.
-- V600BRAF wild type patients: must have received anti-PD-1/PD-L1
single-agent, or in combination with anti-CTLA-4 therapy
--V600BRAF mutant patients: must have received prior anti-PD-1/PD-L1
single-agent, or in combination with anti-CTLA-4 therapy. In addition, subjects
must have received prior V600BRAF inhibitor therapy, either single-agent or in
combination with a MEK inhibitor
-. ECOG performance status 0-2
-. At least one measurable lesion per RECIST v1.1
-. At least one lesion, suitable for sequential mandatory tumor biopsies
on non-randomized arm (1A)
- Subjects must have baseline tumor sample that is positive for LAG-3 per
central assessment at the Novartis-designated laboratory
- Presence of clinically active or unstable brain metastasis.
- Active, known or suspected autoimmune disease or a documented history of
autoimmune disease.
- Active infection requiring systemic antibiotic therapy., - Known history or
current interstitial lung disease or non-infectious pneumonitis
- Known history of testing positive for Human Immunodeficiency Virus (HIV)
infection
- Active hepatitis B virus (HBV) infection (HBsAg positive).
- Subjects with positive test for hepatitis C virus (HCV) RNA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Confirmed ORR using RECIST v1.1, per local assessment</p><br>
- Secondary Outcome Measures
Name Time Method <p>DoR using RECIST v1.1, per local assessment<br /><br><br /><br>PFS and DCR, assessed using RECIST v1.1, per local assessment<br /><br><br /><br>Overall survival (OS)<br /><br><br /><br>Incidence and severity of AE including changes in laboratory values, vital<br /><br>signs and cardiac assessment.<br /><br><br /><br>Dose interruptions, reductions, and permanent discontinuations of study<br /><br>treatments<br /><br><br /><br>Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on treatment<br /><br><br /><br>Proportion of subjects with a favorable biomarker profile (pFBP)</p><br>