Melanoma Clinical Trial

BESPOKE Study of ctDNA Guided Immunotherapy

Summary

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 SIGNATERAâ„¢ testing. SIGNATERAâ„¢ test will be performed at baseline and during routine care. The test results will be part of assessing tumor response. The correlation between SIGNATERAâ„¢ test results and subsequent treatment decisions will be examined to compare actual treatment delivered against treatment decisions potentially impacted by SIGNATERAâ„¢ 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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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Estimated Enrollment:

1539

Study ID:

NCT04761783

Recruitment Status:

Active, not recruiting

Sponsor:

Natera, Inc.

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There is 1 Location for this study

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Natera
San Carlos California, 94070, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

1539

Study ID:

NCT04761783

Recruitment Status:

Active, not recruiting

Sponsor:


Natera, Inc.

How clear is this clinincal trial information?

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