Clinical trial NCT05572463: A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Unresectable Cutaneous Melanoma
Metastatic Cutaneous Melanoma
Keywords: Neoplasms
Melanoma
Malignant Melanoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Innovent Biologics (USA), Inc.
First posted: 2022-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: An open-label platform study that will allow evaluation of multiple novel IPs. The study will include multiple treatment arms that can be added sequentially or in parallel. There will be a master protocol describing study design elements common to all treatment arms with treatment arms described in the appendices, added through amendments.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Adults, age 18 years or older
2. Histologically confirmed unresectable or metastatic cutaneous melanoma
3. Documented radiological progression on prior treatment(s) that included an anti-PD-1/L1 agent
4. Available tumor tissue OR be willing to provide a fresh tumor biopsy
5. Presence of at least one measurable lesion as assessed by CT and/or MRI according to RECIST 1.1
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1
7. Adequate organ and bone marrow function

Exclusion Criteria:

1. Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products
2. Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials
3. Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1
4. Known symptomatic/active untreated central nervous system (CNS) metastasis
5. Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy
6. Inadequate recovery from all recent surgeries
7. At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery
8. Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study)
9. History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load)
10. Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody)
11. Documented history or current diagnosis of clinically significant cardiac disease
12. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy
13. Received solid organ or bone marrow transplantation
14. History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease
15. 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
16. Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose
17. Active gastrointestinal (GI) bleeding or GI perforation or fistula
18. Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry
19. 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

Primary outcomes:
measure: To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)
timeFrame: Up to 28 months
measure: To evaluate the safety, tolerability, and preliminary efficacy of novel immunotherapy IPs in participants with unresectable or metastatic melanoma that progressed while on prior treatment that included an anti-PD-1/L1 agent. (Selection Part)
timeFrame: Day 1 to Day 42
measure: To identify novel immunotherapy IPs to progress into the expansion part (Selection Part)
timeFrame: Up to 2 years
measure: To evaluate the antitumor efficacy of immunotherapy in partcipants with unresectable or metastatic melanoma that progressed while on prior treatment(s) that included an anti-PD-1/L1 agent. (Expansion Part)
timeFrame: Up to 2 years
Secondary outcomes:
measure: To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
timeFrame: Up to 4 years
measure: To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
timeFrame: Up to 2 years
measure: To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
timeFrame: Up to 2 years
measure: To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
timeFrame: Up to 4 years
measure: To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)
timeFrame: Up to 4 years
measure: To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
timeFrame: Up to 25 months
measure: To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)
timeFrame: Up to 25 months
measure: To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
timeFrame: Up to 4 years
measure: To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
timeFrame: Up to 2 years
measure: To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
timeFrame: Up to 2 years
measure: To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
timeFrame: Up to 4 years
measure: To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
timeFrame: Up to 4 years
measure: To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)
timeFrame: Up to 28 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Woolloongabba
country: Australia
facility: Princess Victoria Hospital
state: Queensland
city: Lyon
country: France
facility: Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie
city: Paris
country: France
facility: Hospital Saint Louis
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia, Cordoba
city: Zürich
country: Switzerland
facility: Universitaets Spital Zurich
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust (Oxford)
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals (Preston)
Study officials:
References: