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

Innovent Biologics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Metastatic Cutaneous Melanoma; Unresectable Cutaneous Melanoma

Treatments: Combination Product: Sintilimab + IBI110

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05572463

PLATFORM201

Details and patient eligibility

About

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.

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment Arm 1

Experimental group

Description:

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).

Treatment:

Combination Product: Sintilimab + IBI110