Menu
Not yet recruiting NCT07659379

Gotistobart Long Term Extension (LTE) Study

Phase III Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gotistobart.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials

Overview

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

Detailed description

This is a multi-center, open-label, long term extension study of gotistobart (ONC-392 / BNT316) in participants with advanced or metastatic tumors. The purpose of this trial is to roll over patients who previously enrolled in OncoC4-sponsored gotistobart trials, including those who received gotistobart or gotistobart-based combinations, into an extension trial to collect long-term overall survival and safety data.

Interventions

  • Drug Gotistobart
    ONC-392 will be given following parent trial

Primary outcome measures

  • Overall Survival (OS) [Time frame: 240 months]
Secondary outcome measures (1)
  • Treatment emergent adverse events and immune related adverse events [Time frame: 240 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07659379 · PRESERVE-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗