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Completed

NCT Number: NCT04761783

BESPOKE Study of ctDNA Guided Immunotherapy

This is a prospective data collection study of patients with advanced solid tumors who will receive standard of care immunotherapy (IO) and will be monitored with SIGNATERA™ testing. SIGNATERA™ test will be performed at baseline and during routine care. The test results will be part of assessing tumor response. The correlation between SIGNATERA™ test results and subsequent treatment decisions will be examined to compare actual treatment delivered against treatment decisions potentially impacted by SIGNATERA™ results. Treatment administered, tumor assessment results, time to progression, overall survival, physician questionnaires, and patient-reported outcomes will be collected/recorded.

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Key information

Conditions

Colorectal Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Natera

San Carlos, California, 94070, United States

About this study

Primary Objective:

● To examine the impact of SIGNATERA™ on clinical decision-making regarding continuation, discontinuation, escalation, or de-escalation of immunotherapy.

Secondary Objective:

● To prospectively evaluate the utility of SIGNATERA™ as a tool to detect early evidence of response or progression in patients with advanced solid tumors receiving immune checkpoint inhibitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Prospective Inclusion Criteria:

  • Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
  • Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
  • Melanoma
  • Non-small cell lung cancer
  • Colorectal cancer
  • Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
  • Pembrolizumab (Keytruda)
  • Nivolumab (Opdivo)
  • Ipilimumab (Yervoy)
  • Durvalumab (Imfinzi)
  • Cemiplimab (Libtayo)
  • Atezolizumab (Tecentriq)
  • Avelumab (Bavencio)
  • Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
  • Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
  • ECOG Performance status 0,1, or 2
  • Able to read, understand and provide written informed consent
  • Willing and able to comply with the study requirements
  • Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice

Prospective Exclusion Criteria:

  • Female patients that are pregnant
  • History of bone marrow or organ transplant
  • Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  • Serious medical condition that may adversely affect ability to participate in the study
  • Has initiated Immunotherapy

Control Arm Inclusion Criteria:

  • Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
  • Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
  • Melanoma
  • Non-small cell lung cancer
  • Colorectal cancer
  • Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
  • Pembrolizumab (Keytruda)
  • Nivolumab (Opdivo)
  • Ipilimumab (Yervoy)
  • Durvalumab (Imfinzi)
  • Cemiplimab (Libtayo)
  • Atezolizumab (Tecentriq)
  • Avelumab (Bavencio)
  • Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
  • Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
  • ECOG Performance status 0,1, or 2
  • Able to read, understand and provide written informed consent
  • Willing and able to comply with the study requirements
  • Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice

Control Arm Exclusion Criteria:

  • Female patients that are pregnant
  • History of bone marrow or organ transplant
  • Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
  • Serious medical condition that may adversely affect ability to participate in the study
  • Has initiated Immunotherapy

Treatment and study plan

Primary outcomes

  1. Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy

    Time frame: 2 years

    Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result

Secondary outcomes

  1. To determine progression free survival according to ctDNA change

    Time frame: 2 years

    Compare progression free survival, defined as the duration of time between enrollment and an increase in severity of disease as determined by patient's treating physician, between groups determined by change in ctDNA

  2. Determine overall survival according to ctDNA change

    Time frame: 2 years

    Compare overall survival, defined as the duration of time between enrollment and death for any reason, between groups determined by change in ctDNA

  3. Determine response rate according to ctDNA change in cases with progression of disease on first or second tumor assessment and who continue treatment.

    Time frame: 2 years

    Compare percentage of patients that experience partial or complete response during the study, between groups determined by change in ctDNA

  4. To determine progression free survival according to ctDNA change in cases who achieve stable disease on first tumor assessment.

    Time frame: 2 years

    Compare progression free survival between groups determined by change in ctDNA

  5. To determine duration of response according to ctDNA change in cases who achieve partial response or complete response as best overall response.

    Time frame: 2 years

    Compare duration of response, defined as the length of time from initial response to disease progression, between groups determined by change in ctDNA

  6. To determine percentage of patients with at least 6 months of durable clinical response according to ctDNA change in patients who achieve at least partial response on best tumor assessment.

    Time frame: 2 years

    Among all patients that are clinically identified to experience partial or complete response, percentage that have at least 6 months durable clinical response as determined by ctDNA change

  7. Determine the impact of SIGNATERA on the confidence in immunotherapy treatment decisions based on the number of patients in which treating physician reports SIGNATERA made them more confident in immunotherapy treatment regimen

    Time frame: 2 years

    Percent of patients whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen

  8. Determine the impact of SIGNATERA in informing immunotherapy treatment decisions

    Time frame: 2 years

    Percent of patients whose immunotherapy treatment regimen was changed as a result of SIGNATERA and/or whose treating physician reported that SIGNATERA result made them more confident in selected immunotherapy treatment regimen

  9. Determine the impact of SIGNATERA on patient reported outcomes

    Time frame: 2 years

    Assess patient anxiety levels and wellbeing in patients receiving SIGNATERA ctDNA test results.

    Patient responses to patient reported outcome questionnaires:

    EORTC QLQ-C30

    Assess if SIGNATERA makes patients feel that they are receiving the right treatment and determine if patients will continue to use Signatera in the future to monitor their cancer.

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2021
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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