TerminatedPhase 1NCT03455556
Official study title

Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer

Study summary

This phase I/II trial studies the best dose and side effects of anetumab ravtansine when given together with atezolizumab and how well they work in treating participants with non-small cell lung cancer that has spread to other places in the body. Monoclonal antibodies, such as anetumab ravtansine and atezolizumab, may interfere with the ability of tumor cells to grow and spread.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAnetumab Ravtansine and Atezolizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 6, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Mayo Clinic

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Mayo Clinic
Interventions being studied
Biological: Anetumab Ravtansine; Biological: Atezolizumab; Other: Laboratory Biomarker Analysis
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • PRE REGISTRATION ? INCLUSION CRITERIA: Ability to understand and the willingness to sign a written informed consent document
  • PRE REGISTRATION ? INCLUSION CRITERIA: Patient has disease amenable to biopsy if the archival tissue sample is unavailable; note: Archive sample must not be older than 12 months
  • REGISTRATION ? INCLUSION CRITERIA
  • Phase I only: Diagnosis of advanced/metastatic NSCLC for which no standard treatment option; Phase II only: Advanced NSCLC patients who have received at least 1 platinum-based systemic chemotherapy regimen
  • Patients with tumors having actionable genomic alterations should have received prior therapy with Food and Drug Administration (FDA) approved agents targeting these aberrations (ie EGFR, ALK, ROS1, BRAF V600E)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Phase II only: Must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Ability to understand and the willingness to sign a written informed consent document
  • Histological or cytologically confirmed NSCLC that shows moderate or stronger mesothelin expression in 30% of tumor cells by a companion assay; MSLN expression score using Ventana immunohistochemistry (IHC) SP74 assay; Phase I only: In addition 5- 30% tumor cells and 1, 2, or 3+ MSLN score; Phase II only: 30% tumor cells and either 2+/3+
  • Life expectancy of \>= 12 weeks
  • Absolute neutrophil count \>= 1.5 ? 10\^9/L =\< 14 days prior to registration
  • Platelets \>= 100 ? 10\^9/L =\< 14 days prior to registration
  • Hemoglobin \>= 9 g/dL =\< 14 days prior to registration
  • Potassium \>= lower limit of normal (LLN) range for the institution =\< 14 days prior to registration
  • NOTE: Supplementation may be given before the first dose of study medication
  • Calcium \>= LLN (corrected for serum albumin, if albumin abnormal) =\< 14 days prior to registration
  • NOTE: Supplementation may be given before the first dose of study medication
  • Magnesium \>= LLN =\< 14 days prior to registration
  • NOTE: Supplementation may be given before the first dose of study medication
  • Sodium \>= LLN =\< 14 days prior to registration
  • NOTE: Supplementation may be given before the first dose of study medication
  • Phosphorus \>= LLN =\< 14 days prior to registration
  • NOTE: Supplementation may be given before the first dose of study medication
  • International normalized ratio (INR) =\< 1.5 =\< 14 days prior to registration
  • Serum creatinine =\< 1.5 mg/dL or creatinine clearance \>= 50 mL/min (calculated by Cockcroft Gault equation) =\< 14 days prior to registration
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN or =\< 5 x upper limits of normal (ULN) if liver metastases are present =\< 14 days prior to registration
  • Total bilirubin =\< 1.5 x ULN =\< 14 days prior to registration
  • Standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):
  • QT corrected by Fridericia's formula (QTcF) interval at screening \< 450msec (using Fridericia?s correction)
  • Negative pregnancy test performed =\< 7 days prior to registration (women of childbearing potential only)
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Willing to provide blood samples for correlative research purposes
Reasons someone may not be able to joinExclusion criteria

REGISTRATION ?

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic HospitalPhoenix, Arizona
  • Mayo Clinic in FloridaJacksonville, Florida
  • Mayo ClinicRochester, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2023. Always confirm current availability with the study team.

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