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

Sponsor
Natera, Inc.
Study ID
NCT07689812
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Signatera Genome ultra-sensitive ctDNA blood test — DEVICE
    The test is used to monitor for disease recurrence.

Study Details

This is an open-label, randomized study evaluating whether MRD-guided intermittent ICI therapy provides comparable survival to SOC continuous ICI therapy in subjects with histologically confirmed advanced / metastatic NSCLC, melanoma, MSI-High/dMMR CRC, RCC and other solid tumors. This study will be conducted in up to 100 sites.

Key Dates

First listed
Jul 8, 2026
Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2033
Completion
Mar 31, 2034

Study Design

Enrollment
920 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SOC Continuous ICI
    Participants will continue the current ICI therapy, per approved product label and / or treating investigator's clinical judgement. Standard infusion visits are maintained for the total of 2 years or until radiographic progression, unacceptable toxicity, or withdrawal of consent.
  • Experimental: MRD-Guided Intermittent ICI
    Participants will interrupt ICI therapy upon randomization; reinitiate with the same ICI therapy (monotherapy or combination as documented at enrollment) if ctDNA(+) without evidence of radiographic progression. ICI therapy may again be interrupted after achievement of ≥ 2 consecutive ctDNA-negative results and subsequently initiated upon recurrence of ctDNA positivity without evidence of radiographic progression. This cycle of ctDNA-guided interruption and reinitiation (maximum of 2 ICI interruptions) may continue until radiographic progression is documented, or a maximum of 2 interruptions. Upon radiographic progression, treatment will be determined by the treating physician in accordance with SOC.

Primary Outcome Measure

To demonstrate that MRD-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 ]

Central Contacts

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