IMPRESS Study: Biomarkers to predict for and monitor response to PD-1/PD-L1 inhibitors

The Programmed Death 1 (PD-1) pathway plays a critical role in many malignancies. The FDA recently approved two anti-PD-1 treatments based on data that provide renewed hope for the effective treatment of cancer even in advanced cases, but the clinical outcomes with immune checkpoint agents have been variable. Currently, there are no means by which to predict for an individual patient’s likelihood of benefit from immunotherapy, or to monitor an individual’s response once treatment begins. The IMPRESS Study evaluates the likelihood of patients benefiting from immunotherapy.

The IMPRESS Study involves the collection of participant biospecimens for the evaluation of internally developed assays designed to predict and monitor patient responses to currently available PD-1 and PD-1 ligand (PD-L1) inhibitors. Participants will also have the opportunity to obtain clinical-level sequencing results from tumor biopsies through the Center for Individualized Medicine’s collaboration with the Tempus, a technology company focused on facilitating personalized cancer care.

Participation

IMPRESS Study coordinators recruit eligible patients from the oncology practices at Mayo Clinic's campuses in Minnesota, Arizona and Florida. When the medical oncology provider confirms a patient's eligibility for the protocol, a trained member of the study team provides study information and obtains written informed consent from the patient.

With a participant pool of 200 Mayo Clinic patients, the IMPRESS Study follows patients at time points relevant to the initiation of therapy with PD-1/PD-L1 directed therapy. The goal is to optimize two models; a blood/tissue-based model and a blood-based model to accommodate patients for whom there is no available tumor tissue for biomarker assessment.

A total of 40 mL of blood will be collected from all participants at baseline prior to the initiation of therapy; at the time of radiographic tumor assessments (no more frequently than every six weeks) until disease recurrence or progression, or up to two years (whichever comes first); and then at six month intervals for as long as the participant receives immunotherapy for cancer. Participants may also provide optional consent to provide tumor tissue for research purposes and clinical sequencing prior to the initiation of therapy with an anti-PD-1 or anti-PD-L1 monoclonal antibody.

Eligible participants

  • Are 18 years of age or older
  • Have histologic evidence of malignancy
  • Have a recommendation from their treating provider to initiate standard, non-protocol therapy
  • Understand the protocol and its requirements, risks and discomforts
  • Are able and willing to sign an informed consent

All eligible patients are encouraged to enroll regardless of ethnicity, gender or race.

Contact

Patients and referring physicians can contact our IMPRESS Study team members for more information:

You can also contact the Center for Individualized Medicine for information on other studies and trials.

Support this study

Generous donors and benefactors make this study possible. Your gift supports research in immunotherapy cancer treatment.

You can direct your gift to laboratory research, clinical care or molecular sequencing. Your support helps the IMPRESS Study team evaluate the therapeutic outcomes of novel cancer treatments.

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