Gotistobart Long Term Extension (LTE) Study | NCT07659379

NCT07659379

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A: survival follow up period of the parent trial	No Intervention	Participants enrolling in Cohort A of the trial are those who, upon rolling over into this LTE study, are in the survival follow up period of the parent trial. Participants who discontinue study treatment in parent trial should be encouraged to roll over to this LTE for longer survival follow up through periodic clinical visits or telemedicine visits.
Cohort B: receive the study treatment specified in the parent trial	Experimental	Participants enrolling in Cohort B are those who, upon rolling over into this LTE study, are determined to derive clinical benefit from continued study treatment. These participants will continue to receive the study treatment specified in the parent trial, with gotistobart or an gotistobart-based combination, until one of the following occurs.	Drug: Gotistobart

Name	Type	Description	Arm Group Labels	Other Names
Gotistobart	Drug	ONC-392 will be given following parent trial	Cohort B: receive the study treatment specified in the parent trial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.	240 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events and immune related adverse events	Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs).	240 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 yrs old patients who provide written informed consent for the study.
Patients must have a confirmed diagnosis of advanced unresectable or metastatic solid tumors treated on the parent gotistobart trials that Sponsor designated as PRESERVE-100 transition-ready.
Patients are currently enrolled/randomized and received gotistobart or gotistobart based combination therapy. Patients could be in active treatment or in survival follow up in parent trials.

Exclusion Criteria:

Meet any of the study treatment discontinuation criteria specified in the parent study at the time of roll-over in this extension study.
Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient.
Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study.
Permanent discontinuation of gotistobart or combination therapy for any reason during the parent study, or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable). Exception: Participants who permanently discontinued gotistobart from parent studies remain eligible for enrollment in this study if the parent study permitted continued treatment with the combination agent(s) following discontinuation of gotistobart.
Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study.
Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications.
Concurrent participation in any therapeutic clinical trial (other than the parent study).
Pregnant, lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment in the parent trial.