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Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

NCT03484923 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-06-18

Study results available
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Summary

The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma

Conditions

Interventions

DRUG

PDR001

400 mg of PDR001 administered every 4 weeks intravenously

DRUG

LAG525

600 mg of LAG525 administered every 4 weeks intravenously

DRUG

INC280

400 mg of INC280 administered twice daily orally

DRUG

ACZ885

200 mg of ACZ885 administered every 4 weeks subcutaneosuly

DRUG

LEE011

600 mg of LEE011 orally taken once daily on Days 1-21 of a 28-day cycle

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484923 on ClinicalTrials.gov