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Not yet recruiting NCT07620574

Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study

Phase III Interventional Cancer Renal Cell Carcinoma (RCC) Pancreatic Neuroendocrine Tumors (pNET) Extra-Pancreatic NET (epNET)

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: Cabozantinib, Zanzalintinib, Atezolizumab, Nivolumab.
Who it may be relevant to
Registry conditions: Cancer, Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (pNET), Extra-Pancreatic NET (epNET). Basic parameters: No limits · 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 →

Overview

The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.

Interventions

  • Drug Cabozantinib
    Administered as specified in the parent study.
  • Drug Zanzalintinib
    Administered as specified in the parent study.
  • Drug Atezolizumab
    Administered as specified in the parent study.
  • Drug Nivolumab
    Administered as specified in the parent study.
  • Drug Abiraterone
    Administered as specified in the parent study.
  • Drug Prednisone
    Administered as specified in the parent study.
  • Drug Enzalutamide
    Administered as specified in the parent study.

Primary outcome measures

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 4 years (until the event resolves, returns to baseline, stabilizes, a new anticancer therapy is initiated, or the participant is lost to follow-up or withdraws consent, whichever occurs first)]

Eligibility criteria

Inclusion criteria

  • Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation/withdrawal criteria).
  • Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator.
  • Able to comply with the long-term extension study protocol as determined by the investigator.
  • Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study.

Exclusion criteria

  • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study.
  • Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant.
  • Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study.
  • Permanent discontinuation of all study treatment(s) 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 long-term extension study (if applicable).
  • Concurrent participation in any therapeutic clinical trial (other than the parent study).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07620574 · EXEL-LTE-1 · 2026-525795-26-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗