NCT04761783 — BESPOKE Study of ctDNA Guided Immunotherapy

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Melanoma	Melanoma	ONTOLOGY_EXACT	0.98
Non-small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Prospective arm
description
Patients will receive SIGNATERA™ test results and the immunotherapy treatment regimen, dosing schedule, duration of treatment, number of cycles, and modifications during treatment will be at the discretion of the HCP. Patients will be followed for up to two years with periodic whole blood collection. Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded.
label
Control arm
description
Control cases must have undergone immunotherapy treatment and have follow-up data available in their medical record at the participating site for two years following initiation of immunotherapy or death.

Primary outcomes (1)

measure
Examine the impact of SIGNATERA on treatment decisions on tumor assessment timepoints after initiation of immunotherapy
timeFrame
2 years
description
Percent of patients who have their immunotherapy treatment regimen changed due to post-treatment SIGNATERA ctDNA test result

Secondary outcomes (9)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDKasi PM, Chakrabarti S, Sawyer S, Krainock M, Poklepovic A, Ansstas G, Maninder M, Malhotra M, Ensor J, Gao L, Eroglu Z, Ellers S, Billings P, Rodriguez A, Aleshin A. BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours. BMJ Open. 2022 May 30;12(5):e060342. doi: 10.1136/bmjopen-2021-060342. PMID 35636789