A Phase 2 study investigating the efficacy and safety of ONCOS-102 alone or in combination with balstilimab (a programmed death receptor-1 \[PD-1\] inhibitor).
This study will test ONCOS-102 in combination with novel immune-targeted anti-cancer agents in patients with unresectable or metastatic cutaneous melanoma resistant to anti-PD (L)1 treatment. The purpose of this study is to further evaluate safety and tolerability, as well as anti-tumour activity of ONCOS-102 (both as monotherapy and in combination with anti-PD-1 balstilimab) in the target population. Following a safety run-in period, up to approximately 63 participants with cutaneous melanoma who previously progressed on anti-PD-1/L1-based therapy will be allocated 1:1 to receive either ONCOS-102 alone or ONCOS-102 plus balstilimab. Part 1 - Dose Exploration Run-in: Part 1 of the study will evaluate and further optimise the dose of ONCOS-102; a recommended phase 2 dose (RP2D) for ONCOS-102 will be identified. Part 2 - Multiple Expansion: In the expansion phase, ONCOS-102 alone or in combination with balstilimab will be further evaluated in Cohorts 1 and 2 using the RP2D identified in Part 1. The study is structured to allow for additional combination cohorts to be added to the study following a protocol amendment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oncolytic virus
Anti PD-1
Incidence of treatment-emergent adverse events [safety and tolerability] of ONCOS-102 monotherapy and ONCOS-102 plus balstilimab.
To determine the incidence of treatment emergent adverse events including treatment emergent serious adverse events assessed by CTCAE v5.0, treatment interruptions and discontinuations.
Time frame: 90 days after last treatment
To evaluate the objective response rate (ORR) in individual cohorts using RECIST v1.1
The proportion of patients achieving confirmed complete (CR) or partial response (PR) per RECIST v1.1 criteria
Time frame: Up to 27 months after the last patient first dose
To evaluate the duration of response (DoR) in individual cohorts
Time from observed objective response to first occurrence of disease progression or death based on Investigator assessment according to RECIST v1.1
Time frame: Up to 27 months after the last patient first dose
To evaluate progression-free survival (PFS) in the individual cohorts using the Kaplan-Meier method
Time from treatment initiation to first occurrence of disease progression or death based on Investigator assessment according to RECIST v1.1
Time frame: Up to 27 months after last patient recruited per cohort
To evaluate overall survival (OS) in individual cohorts using the Kaplan-Meier method
Time from treatment initiation to death that occurred up to 24 months after the last patient recruited per cohort
Time frame: Up to 27 months after last patient recruited per cohort
To evaluate PFS rate estimates at 3, 6 and 12 months in individual cohorts
Proportion of patients with a partial or complete response to treatment observed at Month 3 (Month 6 and Month 12) based on RECIST v1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3, 6 and 12 months after last patient recruited per cohort
To evaluate systemic exposure of ONCOS-102
Concentration of virus particles in blood and non-compartmental PK parameters as data allow.
Time frame: Up to 24 months after last patient in the PK sampling group
To estimate baseline presence and incidence of ONCOS-102 anti-drug antibodies (ADA) and neutralising antibodies (NAb) during study
ADA (screening, confirmatory results: positive or negative; titres), NAb (titres)
Time frame: Up to 24 months after last patient in the pharmacokinetic sampling group