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

NCT05572463 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: PLATFORM201
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 13

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.

Conditions

Unresectable Cutaneous Melanoma; Metastatic Cutaneous Melanoma

Keywords

Neoplasms; Melanoma; Malignant Melanoma

Outcome Measures

Primary Outcomes (4)

• 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)

  Incidence and severity of Adverse Events (AEs) and laboratory abnormalities

  Up to 28 months

• 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)

  Incidence of dose-limiting toxicities (DLTs) \[only applicable for safety run-in portion\]

  Day 1 to Day 42

• To identify novel immunotherapy IPs to progress into the expansion part (Selection Part)

  Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 2 years

• 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)

  ORR by RECIST 1.1

  Up to 2 years

Secondary Outcomes (13)

• To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)

  Up to 4 years

• To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)

  Up to 2 years

• To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)

  Up to 2 years

• To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)

  Up to 4 years

• To evaluate the preliminary anti-tumor efficacy by assessing additional endpoints of novel immunotherapy IPs (Selection Part)

  Up to 4 years

Study Arms (1)

Treatment Arm 1

EXPERIMENTAL

Sintilimab is a recombinant fully human anti-programmed cell death protein 1 (PD-1) monoclonal antibody, and IBI110 is a recombinant fully human anti-lymphocyte activation gene 3 (LAG3) monoclonal antibody. Sintilimab (IBI308) will be administered intravenously (IV) in combination with IBI110 administered intravenously (IV) every 3-weeks (Q3W).

Combination Product: Sintilimab + IBI110

Interventions

Sintilimab + IBI110 COMBINATION_PRODUCT

IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule

Also known as: Sintilimab (IBI308)

Treatment Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead
• Innovent Biologics (USA), Inc.: collaborator

Study Sites (13)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Princess Victoria Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie

Lyon, 69002, France

Location

Hospital Saint Louis

Paris, 75010, France

Location

Universitatsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Universitatsklinikum Essen

Essen, 45147, Germany

Location

Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona

Barcelona, 8916, Spain

Location

Hospital Universitario Reina Sofia, Cordoba

Córdoba, 14004, Spain

Location

Universitaets Spital Zurich

Zurich, 8091, Switzerland

Location

Cambridge University Hospitals NHS Foundation Trust (Oxford)

Cambridge, CB2 0QQ, United Kingdom

Location

Lancashire Teaching Hospitals (Preston)

Preston, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Neoplasms

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

FR (2); DE (2); CH (1); GB (2); US (3); ES (2); AU (1)