A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Unresectable Cutaneous Melanoma, Metastatic Cutaneous Melanoma
In brief
This is a platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target unresectable or metastatic cutaneous melanoma in participants who have failed standard treatment.
Key facts
- Study ID
- NCT05572463
- Run by
- Innovent Biologics (Suzhou) Co. Ltd.
- People needed
- 0
- Starts
- 2022-11-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2022-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults, age 18 years or older
- Histologically confirmed unresectable or metastatic cutaneous melanoma
- Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent
- Available tumor tissue OR be willing to provide a fresh tumor biopsy
- Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
- Adequate organ and bone marrow function
You may not qualify if…
- Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products
- Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials
- Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1
- Known symptomatic/active untreated central nervous system (CNS) metastasis
- Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy
- Inadequate recovery from all recent surgeries
- At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery
- Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study)
- History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load)
- Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody)
- Documented history or current diagnosis of clinically significant cardiac disease
- History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy
- Received solid organ or bone marrow transplantation
- History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease
- Active or previously documented autoimmune disease including but not limited to inflammatory bowel disease, diverticulitis, celiac disease, systemic lupus erythematosus, Wegener syndrome, multiple sclerosis, and vasculitis
- Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose
- Active gastrointestinal (GI) bleeding or GI perforation or fistula
- Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry
- Pregnant or lactating women or women who intend to get pregnant or lactate during the study and up to 120 days after the end of treatment
Where it is running
- University of California San Francisco Medical Center — San Francisco, California, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Princess Victoria Hospital — Woolloongabba, Queensland, Australia
- Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie — Lyon, France
- Hospital Saint Louis — Paris, France
- Universitatsklinikum Carl Gustav Carus — Dresden, Germany
- Universitatsklinikum Essen — Essen, Germany
- Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona — Barcelona, Spain
- Hospital Universitario Reina Sofia, Cordoba — Córdoba, Spain
- Universitaets Spital Zurich — Zurich, Switzerland
- Cambridge University Hospitals NHS Foundation Trust (Oxford) — Cambridge, United Kingdom
- Lancashire Teaching Hospitals (Preston) — Preston, United Kingdom
Full record on ClinicalTrials.gov
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