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
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
Treatments tested in this trial
- Gotistobart
Treatment groups
20 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov