A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
Reason given: Sponsor Strategy
Key facts
- Where
- Detroit, Hackensack, and San Francisco, United StatesSee the 3 sites
- Phase
- Phase 1/2
Where in United States
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- University of California San Francisco Medical CenterSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT05572463
- Record updated
- 18 November 2022
- Original description
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.Read full original descriptionShow less
A Randomized, Open-label, Multicenter, Multi-arm, Phase 1b/2 Platform Study to Evaluate Safety and Efficacy of Investigational Immunotherapies in Participants With Previously Treated Unresectable or Metastatic Melanoma
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.
Inclusion: 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.
Exclusion: Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1; Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy; 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 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; 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; 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; Active gastrointestinal (GI) bleeding or GI perforation or fistula; Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry; Known symptomatic/active untreated central nervous system (CNS) metastasis; Inadequate recovery from all recent surgeries; 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.