Melanoma Clinical Trial

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for Cohort 1:

ECOG performance status (PS) of 0 or 1
Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months
Fit and planned for CLND
Measurable disease according to RECIST v1.1
Availability of a representative tumor specimen
Adequate hematologic and end-organ function
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.

Exclusion Criteria for Cohort 1:

Mucosal, uveal and acral lentiginous melanoma
Distantly metastasized melanoma
History of in-transit metastases within the last 6 months
Prior radiotherapy
Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
Prior allogeneic stem cell or solid organ transplantation
Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
Active or history of autoimmune disease or immune deficiency

Inclusion Criteria for Cohort 2:

ECOG PS of 0 or 1
Life expectancy >= 3 months, as determined by the investigator
Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
Measurable disease according to RECIST v1.1
Availability of a representative tumor specimen
Adequate hematologic and end-organ function
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.

Exclusion Criteria for Cohort 2:

Mucosal and uveal melanoma
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
Prior allogeneic stem cell or solid organ transplantation
Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
Active or history of autoimmune disease or immune deficiency
Symptomatic, untreated, or progressing CNS metastases
Active or history of carcinomatous meningitis/leptomeningeal disease
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled or symptomatic hypercalcemia

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

191

Study ID:

NCT05116202

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 21 Locations for this study

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City of Hope
Duarte California, 91010, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles California, 90025, United States
Providence St Johns Health Center
Santa Monica California, 90404, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Melanoma Institute Australia
North Sydney New South Wales, 2060, Australia
Linear Clinical Research Limited
Nedlands Western Australia, 6009, Australia
Hopital de la Timone
Marseille , 13005, France
APHP - Hospital Saint Louis
Paris , 75475, France
Institut Universitaire du Cancer de Toulouse-Oncopole
Toulouse , 31059, France
Institut Gustave Roussy
Villejuif , 94805, France
Azienda Ospedaliera Universitaria Senese
Siena Abruzzo, 53100, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Ospedale S.Maria della Misericordia
Perugia Umbria, 06132, Italy
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Clinica Universidad de Navarra ; Servicio de Farmacia
Madrid , 28027, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

191

Study ID:

NCT05116202

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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