Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElephas

About this trial

This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide informed consent for participation

Age ≥18 years at time of consent.

Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.

Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.

Disqualifiers

Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.

Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.

Pregnant person(s).

Trial population

Adults aged 18 years or older, who are able and willing to provide written informed consent, have a suspected or confirmed cancer diagnosis and will be undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Subjects must be clinically able, at investigator discretion, to undergo additional biopsy passes during their biopsy. Biopsy specimen(s) will be obtained during a standard of care (SOC) procedure. If a subject receives a subsequent SOC biopsy for clinical diagnosis purposes, additional sample(s) may be collected and sent to the Sponsor.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Study Population1 intervention

Trial outcomes

Primary outcomes

1

Predicting In-Vivo Clinical Response to Immune Checkpoint Inhibitors & Researching Mechanisms of Tumor Cutting and Imaging

Collect human tumor specimens to research mechanisms of tumor cutting, imaging, and ex-vivo immunotherapy treatment response, while maintaining cell stability in a live tumor microenvironment.

Time frame
Study duration is approximately 36 months from enrollment to end of study.

Secondary outcomes

Other outcomes

Sponsors and contacts

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