Melanoma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female must be ≥ 12 years For adolescents only (12-17 years): body weight > 40kg Histologically confirmed unresectable or metastatic cutaneous melanoma

Previously treated for unresectable or metastatic melanoma:

Participants with NRAS mutation:
Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents.
A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents administered with CPI are permitted.
To rule out pseudo-progression, participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. Confirmation is not required for patients who remained on treatment for >6 months.
Participants with BRAFV600 mutant disease:
Participants must have received prior systemic therapy for unresectable or metastatic melanoma with checkpoint inhibitors (CPI), either an anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4, investigational agents, chemotherapy or locally directed anti-neoplastic agents. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi (+/- CPI allowed) as the last prior therapy.
A maximum of two prior lines of systemic CPI-containing immunotherapy for unresectable or metastatic melanoma are allowed. Additional agents with CPI are permitted.
A maximum of one line of targeted therapy is allowed, and it must be the most recent line of therapy.
Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:

≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
≤ 2 weeks for small molecule therapeutics.
≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
≤ 4 weeks for chemotherapy agents, locally directed anti-neoplastic agents, or other investigational agents.
≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin c.

Participants participating in additional parallel investigational drug or medical device studies.

All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).

Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Other protocol-defined exclusion criteria may apply

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

134

Study ID:

NCT04417621

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 35 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute .
Los Angeles California, 90025, United States
UCSF Medical Center .
San Francisco California, 94143, United States
Florida Cancer Specialists Sarasota Office
Fort Myers Florida, 33901, United States
H Lee Moffitt Cancer Center and Research Institute Moffitt McKinley Outpatient Ct
Tampa Florida, 33612, United States
Massachusetts General Hospital Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute Dept.of DFCI
Boston Massachusetts, 02215, United States
Mayo Clinic Mayo Rochester
Rochester Minnesota, 55905, United States
NYU Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering Dept. of MSKCC
New York New York, 10017, United States
University of Pittsburgh Med Center
Pittsburgh Pennsylvania, 15213, United States
Univ of TX MD Anderson Cancer Cntr .
Houston Texas, 77030, United States
Novartis Investigative Site
Caba Buenos Aires, C1426, Argentina
Novartis Investigative Site
North Sydney New South Wales, 2060, Australia
Novartis Investigative Site
Wooloongabba Queensland, 4102, Australia
Novartis Investigative Site
Subiaco Western Australia, 6008, Australia
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Wilrijk , 2610, Belgium
Novartis Investigative Site
Lille , 59037, France
Novartis Investigative Site
Marseille , 13885, France
Novartis Investigative Site
Paris 10 , 75475, France
Novartis Investigative Site
Pierre Benite , 69495, France
Novartis Investigative Site
Toulouse , 31059, France
Novartis Investigative Site
Villejuif , 94800, France
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Essen , 45147, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Tuebingen , 72076, Germany
Novartis Investigative Site
Ramat Gan , 52621, Israel
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Maastricht , 6229 , Netherlands
Novartis Investigative Site
Oslo , 0379, Norway
Novartis Investigative Site
Lausanne , 1011, Switzerland
Novartis Investigative Site
Zuerich , 8091, Switzerland
Novartis Investigative Site
Manchester , M20 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

134

Study ID:

NCT04417621

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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