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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.

NCT07689812 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2026-08-04

No results posted yet for this study

Summary

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.

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • NSCLC (Non-small Cell Lung Cancer)
  • NSCLC (Non-small Cell Lung Carcinoma)
  • NSCLC
  • Melanoma (Skin Cancer)
  • Melanoma (Skin) Stage IV
  • CRC
  • MSI High Colorectal Cancer
  • DMMR Colorectal Cancer
  • RCC, Renal Cell Cancer
  • RCC
  • Solid Tumors
  • Metastatic Solid Tumors
  • Advanced Solid Tumors
  • Advanced Solid Tumors Cancer

Interventions

DEVICE

Signatera Genome ultra-sensitive ctDNA blood test

The test is used to monitor for disease recurrence.

Sponsors & Collaborators

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Caitlin Shonewolf, MD · Natera, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2033-12-31
Completion
2034-03-31
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689812 on ClinicalTrials.gov