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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Unresectable Cutaneous Melanoma Metastatic Cutaneous Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Sintilimab + IBI110

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Sintilimab + IBI110

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Sintilimab (IBI308)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No