Gotistobart Long Term Extension (LTE) Study

ConditionAdvanced Solid Tumor

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorOncoC4, Inc.

About this trial

This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Factorial

Treatments tested in this trial

Gotistobart
Drug
ONC-392 will be given following parent trial

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Cohort A: survival follow up period of the parent trialNo intervention 0 interventions

Group B: Cohort B: receive the study treatment specified in the parent trialExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

240 months

Secondary outcomes

Treatment emergent adverse events and immune related adverse events

Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs).

Time frame

240 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OncoC4, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: