Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04417621
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • LXH254 — DRUG
    LXH254 will be supplied as tablet for oral use.
  • LTT462 — DRUG
    LTT462 will be supplied as hard gelatin capsule for oral use.
  • Trametinib — DRUG
    Trametinib will be supplied as film-coated tablet for oral use
  • Ribociclib — DRUG
    Ribociclib will be supplied in tablets and hard gelatin capsules.

Study Details

The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in previously treated unresectable or metastatic melanoma

Key Dates

Start date
Oct 30, 2020
Status verified
Mar 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
134 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LXH254 + LTT462
  • Experimental: LXH254 + trametinib
  • Experimental: LXH254 + ribociclib

Primary Outcome Measure

Overall Response Rate [ Time Frame: 35 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
UCSF Medical CenterSan FranciscoCalifornia94143-
Florida Cancer SpecialistsFort MyersFlorida33901-
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic Mayo RochesterRochesterMinnesota55905-
Mayo Clinic RochesterRochesterMinnesota55905-
Memorial Sloan KetteringNew YorkNew York10017-
NYU Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-
University of Pittsburgh Med CenterPittsburghPennsylvania15213-
Univ of TX MD Anderson Cancer CntrHoustonTexas77030-

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