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Immune Checkpoint Inhibitors

Nivolumab

Intravenous with or without Intratumoral RT-01 in the treatment of patients with advanced solid tumors combined with or without Nivolumab in the treatment of patients with advanced solid tumors

Intravenous injection of RT-01 with or without Nivolumab

Oncolytic Virus Injection (RT-01）

Peihua Lu, MD

This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.

To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.

RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors

An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors

Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.

Graded according to the NCI CTCAE version 5.0.

Proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST v1.1 imaging.

Proportion of patients in the analysis population who have complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 imaging.

Survival time is defined as the time from registration to death due to any cause.

Progression-free survival is defined as the time from registration to the earliest date documentation of disease progression or death due to any cause.

Assessed via quantitative reverse transcriptase polymerase chain reaction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors	NCT05122572	Advanced Solid ...	Oncolytic Virus...	18 Years -	Wuxi People's Hospital

Spots Global Cancer Trial Database for inmmune checkpoint inhibitors