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Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

NCT02631447 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2024-06-07

No results posted yet for this study

Summary

To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation.

Conditions

Interventions

DRUG

LGX818

LGX818 450 mg p.o. od

DRUG

MEK162

MEK162 45 mg p.o. bid

DRUG

Nivolumab

Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks

DRUG

Ipilimumab

Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks

Sponsors & Collaborators

  • Clinical Research Technology S.r.l.

    collaborator INDUSTRY

  • Fondazione Melanoma Onlus

    lead OTHER

Principal Investigators

  • Paolo Ascierto, MD · Fondazione Melanoma Onlus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Austria
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02631447 on ClinicalTrials.gov