Melanoma Clinical Trial

A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma

Summary

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.

View Full Description

Full Description

This is a Phase 1b/2, randomized, open label, multicenter, platform study evaluating the safety and efficacy of multiple novel investigational products (IPs) that target mechanisms implicated in resistance to immunotherapy in participants with unresectable or metastatic cutaneous melanoma who have resistance to anti-PD-1/L1 agents. This study will include multiple treatment arms that can be added sequentially or in parallel.

Each arm consists of a selection and expansion part. The selection part is used for evaluation of safety and preliminary efficacy in each arm. The selection part may also include a safety run-in portion for preliminary safety evaluation and dose confirmation prior to proceeding. If the criteria for safety and preliminary efficacy are met, the arm will open for additional enrollment in an expansion phase.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT05572463

Recruitment Status:

Withdrawn

Sponsor:

Innovent Biologics (Suzhou) Co. Ltd.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 13 Locations for this study

See Locations Near You

University of California San Francisco Medical Center
San Francisco California, 94143, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Princess Victoria Hospital
Woolloongabba Queensland, 4102, Australia
Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie
Lyon , 69002, France
Hospital Saint Louis
Paris , 75010, France
Universitatsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitatsklinikum Essen
Essen , 45147, Germany
Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona
Barcelona , 8916, Spain
Hospital Universitario Reina Sofia, Cordoba
Córdoba , 14004, Spain
Universitaets Spital Zurich
Zürich , 8091, Switzerland
Cambridge University Hospitals NHS Foundation Trust (Oxford)
Cambridge , CB2 0, United Kingdom
Lancashire Teaching Hospitals (Preston)
Preston , PR2 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT05572463

Recruitment Status:

Withdrawn

Sponsor:


Innovent Biologics (Suzhou) Co. Ltd.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.