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A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.

ConditionsNSCLC (Advanced Non-small Cell Lung Cancer)NSCLC (Non-small Cell Lung Cancer)NSCLC (Non-small Cell Lung Carcinoma)NSCLCMelanoma (Skin Cancer)Melanoma (Skin) Stage IVCRCMSI High Colorectal CancerDMMR Colorectal CancerRCC, Renal Cell CancerRCCSolid TumorsMetastatic Solid TumorsAdvanced Solid TumorsAdvanced Solid Tumors Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNatera, Inc.

About this trial

This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced/metastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)/Deficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed consent

Age ≥ 18 years

ECOG 0-2.

Melanoma: Unresectable recurrent, advanced, or metastatic

Disqualifiers

Available alternate treatment options with curative intent, e.g. surgery and / or RT and / or Chemotherapy.

Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.

Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.

Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Signatera Genome ultra-sensitive ctDNA blood test

    Device

    The test is used to monitor for disease recurrence.

Treatment groups

920 Participants
are divided into 2 treatment groups
Group A: SOC Continuous ICIExperimental treatment 1 intervention
Group B: ctDNA-Guided Intermittent ICIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To demonstrate that ctDNA-guided intermittent ICI therapy results in at least 50% of patients who do not reinitiate systemic therapy prior to 6 months from randomization.

Time frame
6 months from randomization
2

To demonstrate that ctDNA-guided intermittent ICI therapy is non-inferior to SoC continuous ICI therapy as measured by 36 month OS in advanced/metastatic solid tumor patients.

Time frame
3 years from randomization to death from any cause

Secondary outcomes

1

To compare ctDNA-guided intermittent ICI therapy to SoC continuous ICI therapy as measured by 36 month progression-free survival (PFS) (blinded independent central review [BICR] assessed) in advanced/metastatic solid tumor patients.

Time frame
3 years from randomization to the first occurrence of disease progression measured by RECIST 1.1 or death from any cause, whichever occurs first
2

To compare the tolerability between the ctDNA-guided intermittent ICI therapy and SoC continuous ICI therapy using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

Time frame
From randomization to Year 3

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Natera, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: