A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma

Completed · Phase 1

Conditions studied: Metastatic Melanoma

In brief

This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.

Key facts

Study ID

NCT03875079

Run by

Hoffmann-La Roche

People needed

83

Starts

2019-06-24

Expected to finish

2022-07-14

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed unresectable stage III or stage IV cutaneous or mucosal melanoma (AJCC v8.0).
• Participants need to have known BRAF status.
• CPI naïve melanoma population: Participants with unresectable stage III or stage IV cutaneous or mucosal melanoma who have not received prior treatment for advanced disease. BRAF mutation-positive patients are eligible without prior treatment or after failure of BRAF directed inhibitor therapy.
• CPI experienced melanoma population: Participants with unresectable stage III or stage IV cutaneous melanoma. Participants must have progressed during or after treatment with anti PD-1 antibody therapy, either as monotherapy or in combination with other agent(s).
• Participants should have adequate cardiovascular, hematological, liver, and renal function.
• Participants with unilateral pleural effusion are eligible if they fulfill both of the following: NYHA Class 1; Forced expiratory volume 1 (FEV1) >70% and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.

You may not qualify if…

• Medical Conditions
• Rapid disease progression or suspected hyperprogression (as determined by the Investigator) or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention.
• Known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease:
• Participants with previously treated brain metastases may participate.
• History of treated asymptomatic CNS metastases.
• An active second malignancy (exceptions are non-melanoma skin cancer, cervical carcinoma in situ, or prostate carcinoma that is in remission under androgen deprivation therapy for ≥ 2 years, or participants who have a history of malignancy and have been treated with curative intent and the participant is expected to be cured as per Investigator's assessment).
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, and known autoimmune diseases or other disease with ongoing fibrosis (such as scleroderma, pulmonary fibrosis. and emphysema).
• Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration.
• Active or uncontrolled infections, including latent tuberculosis.
• Known HIV infection.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Severe infection within 4 weeks before study treatment administration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• History of chronic liver disease or evidence of hepatic cirrhosis.
• Dementia or altered mental status that would prohibit informed consent.
• History of autoimmune disease.
• Adverse events related to any previous radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure that have not resolved to Grade =< 1, except alopecia (any grade) and Grade 2 peripheral neuropathy.
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
• Bilateral pleural effusion.
• Severe dyspnea at rest or requiring supplementary oxygen therapy.
• Concurrent therapy with any other investigational drug (defined as a treatment for which there is currently no regulatory authority approved indication).
• Immunomodulating agents: Last dose with any of the following agents, for example, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab (or similar agents) < 28 days before study treatment administration. Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease)
• Treatment with systemic immunosuppressive medications including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1 Day 1.
• Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy.
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
• Major surgery or significant traumatic injury < 28 days before study treatment administration (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment.

Where it is running

• Yale University — New Haven, Connecticut, United States
• University of Iowa — Iowa City, Iowa, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Melanoma Institute Australia — North Sydney, New South Wales, Australia
• Peter Maccallum Cancer Institute; Clinical Trial Unit — Melbourne, Victoria, Australia
• UZ Antwerpen — Edegem, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada
• Hopital Claude Huriez; Sce Dermatologie — Lille, France
• Hôpital de la Timone; Dermatologie — Marseille, France
• Centre Eugene Marquis; Service d'oncologie — Rennes, France
• Institut Gustave Roussy; Dermatologie — Villejuif, France
• Main Military Clinical Hospital named after N.N. Burdenko — Moscow, Moscow Oblast, Russia
• Russian Oncology Research Center n.a. N.N. Blokhin — Moscow, Russia
• P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept — Moscow, Russia
• FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" — Saint Petersburg, Russia
• Hospital Universitari Vall d'Hebron; Oncology — Barcelona, BARCELONA, Spain
• Hospital Clínic i Provincial; Servicio de Oncología — Barcelona, BARCELONA, Spain
• Clinica Universidad de Navarra Madrid; Servicio de Oncología — Madrid, Madrid, Spain
• Hospital Ramon y Cajal; Servicio de Oncologia — Madrid, Madrid, Spain
• Clinica Universitaria de Navarra; Servicio de Oncologia — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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