BESPOKE Study of ctDNA Guided Immunotherapy

Launched by NATERA, INC. · Feb 16, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Prospective Inclusion Criteria:
• • 1. Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
• 2. Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
• • 1. Melanoma
• • 2. Non-small cell lung cancer
• • 3. Colorectal cancer
• 3. 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:
• • 1. Pembrolizumab (Keytruda)
• • 2. Nivolumab (Opdivo)
• • 3. Ipilimumab (Yervoy)
• • 4. Durvalumab (Imfinzi)
• • 5. Cemiplimab (Libtayo)
• • 6. Atezolizumab (Tecentriq)
• • 7. Avelumab (Bavencio)
• • 4. 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.
• • 5. 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
• • 6. ECOG Performance status 0,1, or 2
• • 7. Able to read, understand and provide written informed consent
• • 8. Willing and able to comply with the study requirements
• • 9. 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:
• • 1. Female patients that are pregnant
• • 2. History of bone marrow or organ transplant
• • 3. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
• • 4. Serious medical condition that may adversely affect ability to participate in the study
• • 5. Has initiated Immunotherapy
• Control Arm Inclusion Criteria:
• • 1. Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
• 2. Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
• • 1. Melanoma
• • 2. Non-small cell lung cancer
• • 3. Colorectal cancer
• 3. 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:
• • 1. Pembrolizumab (Keytruda)
• • 2. Nivolumab (Opdivo)
• • 3. Ipilimumab (Yervoy)
• • 4. Durvalumab (Imfinzi)
• • 5. Cemiplimab (Libtayo)
• • 6. Atezolizumab (Tecentriq)
• • 7. Avelumab (Bavencio)
• • 4. 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.
• • 5. 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
• • 6. ECOG Performance status 0,1, or 2
• • 7. Able to read, understand and provide written informed consent
• • 8. Willing and able to comply with the study requirements
• • 9. 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:
• • 1. Female patients that are pregnant
• • 2. History of bone marrow or organ transplant
• • 3. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
• • 4. Serious medical condition that may adversely affect ability to participate in the study
• • 5. Has initiated Immunotherapy