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WithdrawnNCT05572463Updated Nov 18, 2022

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

A Phase 1/2 interventional study of Sintilimab + IBI110 in Unresectable Cutaneous Melanoma and Metastatic Cutaneous Melanoma, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Withdrawn at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Sponsor Strategy
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unresectable Cutaneous Melanoma
  • Metastatic Cutaneous Melanoma

Keywords

  • Neoplasms
  • Melanoma
  • Malignant Melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

Browse Melanoma studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment Arm 1

    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

  • Combination productSintilimab + IBI110

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

    Also known as: Sintilimab (IBI308)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 28 months

  2. 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) \[only applicable for safety run-in portion\]

    Time frame: Day 1 to Day 42

  3. 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

    Time frame: Up to 2 years

  4. 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

    Time frame: Up to 2 years

Secondary outcomes

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

    Duration of response (DOR) by RECIST 1.1

    Time frame: Up to 4 years

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

    Time to Response (TTR) by RECIST 1.1

    Time frame: Up to 2 years

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

    Disease control rate (DCR) by RECIST 1.1

    Time frame: Up to 2 years

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

    Progression-free survival (PFS) by RECIST 1.1

    Time frame: Up to 4 years

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

    Overall survival (OS)

    Time frame: Up to 4 years

  6. To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)

    Pharmacokinetic parameters including, but not limited to area under the concentration -time curve over dosing interval (AUCtau), Maximum observed plasma concentration at steady state (Cmax,ss), and trough plasma concentration at steady state (Ctrough,ss)

    Time frame: Up to 25 months

  7. To characterize the pharmacokinetic (PK) profile and immunogenicity (Selection, Expansion Part)

    Prevalence and incidence of anti-product antibodies (ADA, Nab)

    Time frame: Up to 25 months

  8. To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)

    Duration of response (DOR) by RECIST 1.1

    Time frame: Up to 4 years

  9. To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)

    Time to Response (TTR) by RECIST 1.1

    Time frame: Up to 2 years

  10. To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)

    Disease control rate (DCR) by RECIST 1.1

    Time frame: Up to 2 years

  11. To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)

    Progression-free survival (PFS) by RECIST 1.1

    Time frame: Up to 4 years

  12. To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)

    Overall survival (OS)

    Time frame: Up to 4 years

  13. To further evaluate the safety and tolerability of novel immunotherapy IPs (Expansion Part)

    Incidence and severity of AEs and laboratory abnormalities

    Time frame: Up to 28 months

07

Study locations

13 sites
  • 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 0QQ, United Kingdom
  • Lancashire Teaching Hospitals (Preston)
    Preston, PR2 9HT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05572463
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborators
Innovent Biologics (USA), Inc.
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 18, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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