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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
IBI110 infusion in combination with Sintilimab (IBI308) infusion will be given on a Q3W schedule
University of California San Francisco Medical Center
San Francisco, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Princess Victoria Hospital
Woolloongabba, Queensland, Australia
Hospices Civil De Lyon Nord - Centre Hospitalier Lyon Sud - Dermatologie
Lyon, France
Hospital Saint Louis
Paris, France
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Universitatsklinikum Essen
Essen, Germany
Institut Catala d'Oncologia Hospital Universitari Germans Trials I Pujol, Barcelona
Barcelona, Spain
Hospital Universitario Reina Sofia, Cordoba
Córdoba, Spain
...and 3 more locations
Time frame: Up to 2 years
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
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
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
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
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
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
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
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
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
To evaluate anti-tumor efficacy by assessing additional endpoints by RECIST 1.1 (Expansion Part)
Overall survival (OS)
Time frame: Up to 4 years
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