Evaluation of the NantHealth GPS Cancer Test in Patients With Advanced Cancers

Quantitative Targeted Proteomics Detected by Mass Spectrometry With Whole Genome (DNA) and Whole Transcriptome (RNA) Sequencing in Advanced Cancers

Among patients with advanced (metastatic) cancers, detailed characterizations of the tumor utilizing genomic and proteonomic techniques may help guide treatment. It, however, remains unclear if these new diagnostic technologies truly influence clinical and economic outcomes. This study will evaluate if patients treated according to the results of the NantHealth GPS Cancer test achieve optimal outcomes compared to patients whose treatment are discordant with GPS Cancer recommendations.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Cancer; Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Melanoma; Metastatic Prostate Cancer; Metastatic Colon Cancer
• Intervention / Treatment: Diagnostic test: NantHealth GPS Cancer Test

Detailed Description

Personalized Medicine approaches to cancer management require detailed diagnostic evaluations. Broad genomic profiling,using whole genome (DNA) and whole transcriptome(RNA) sequencing platforms,holds the promise of identifying tumor related mutations that are amenable to targeted therapies, with the potential for improved clinical outcomes and lower toxicities compared to traditional cytotoxic chemotherapy. Proteomic approaches may add additional insights into treatment selection by identifying protein biomarkers known to induce drug resistance or indicate drug sensitivity for chemotherapy, monoclonal antibody therapy, hormonal therapy, targeted therapy and immunotherapy. The full value of these approaches has not been realized in routine clinical cancer care.

GPS Cancer™ is a comprehensive test available through NantHealth. GPS Cancer which integrates whole genome (DNA) sequencing, whole transcriptome (RNA) sequencing, and quantitative proteomics through mass spectrometry, provides oncologists with a comprehensive molecular profile of a patient's cancer to inform personalized treatment strategies. GPS Cancer testing is conducted in CLIA-certified and CAP-accredited laboratories.

Hypothesis:

1. The addition of proteomics to next generation sequencing (NGS) via the NantHealthGPS Cancer test and the incorporation of whole genome sequencing will identify treatment algorithms with increased likelihood of successful clinical outcomes in patients with advanced cancers.

Study Design(summary):

1. The patient population will consist of 160 total individuals with tumor tissue available for NantHealth GPS Cancer testing: (1) pancreatic cancer patients ineligible for curative surgery, (2) metastatic breast cancer, (3) advanced stage (non-resectable/metastatic/incurable) lung cancer, (4) metastatic non-resectable malignant melanoma, (4) metastatic colon cancer not amenable to curative therapy, and (5) metastatic hormone refractory prostate cancer.
2. The treating oncologists will declare any planned treatment strategies before the testing results are obtained.These plans will be compared retrospectively with the actual treatment plans delivered to the patient to determine the "change rate".
3. The executive steering committee will review the NantHealthGPS Cancer reports and compare the results against the actual delivered therapy. Patients will be segregated into cohorts of "GPS treatment concordant" and "GPS treatment discordant".
4. A cohort of patients with similar diseases(matched via the COTA Nodal Address system) will be drawn at a ratio of 3 to 1 from the COTA database.
5. The time on chosen therapy (time to treatment failure) will be calculated for the cohort of patients with "GPS treatment concordant", "GPS treatment discordant", and "matched controls". The times will be compared using standard statistical analyses.
6. The total cost of care for the three treatment cohorts will also be compared.
7. Subjects must possess medical insurance coverage from Horizon Blue Cross Blue Shield of New Jersey in order to participate. A maximum of 160 patient samples will be tested.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • RCCA - Central Jersey Division
    • Freehold, New Jersey, United States, 07728
      • RCCA - Freehold Division
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health System
    • Hackettstown, New Jersey, United States, 07840
      • RCCA - Hackettstown Division
    • Howell, New Jersey, United States, 07731
      • RCCA - Howell Division
    • Little Silver, New Jersey, United States, 07739
      • RCCA - Little Silver Division
    • Marmora, New Jersey, United States, 08223
      • RCCA - Marmora Division
    • Mount Holly, New Jersey, United States, 08060
      • RCCA - Mount Holly Division
    • Pompton Plains, New Jersey, United States, 07444
      • RCCA - Pompton Plains Division
    • Sparta, New Jersey, United States, 07871
      • RCCA - Sparta Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population is oncology patients consenting to receive active therapy.

Description

Inclusion Criteria:

• Pancreatic cancer patients ineligible for curative surgery at time of entry will be eligible for enrollment.
• Metastatic breast cancer at any time in their treatment history will be eligible for enrollment.
• Advanced stage (non-resectable/metastatic/incurable) lung cancer patients will be eligible for enrollment.
• Metastatic colon cancer patients not amenable to curative therapy will be eligible for enrollment.
• Metastatic non-resectable malignant melanoma patients will be eligible for enrollment.

NantHealth GPS Cancer in Advanced Cancers

• Metastatic hormone refractory prostate cancer patients will be eligible for enrollment. Patients must have tumor tissue available prior to the initiation of the current line of treatment available for GPS Cancer testing.
• Metastatic bladder cancer
• Non-resectable metastatic Renal carcinoma
• Non-resectable metastatic Head and Neck cancer
• Metastatic Ovarian cancer
• Metastatic Cervical cancer
• Metastatic Sarcoma
• Patients must sign informed consent for this study.
• Patients must have private medical insurance coverage through Horizon Blue Cross Blue Shield. This is limited to insured commercial members, including HMO, and excluding, for the avoidance of doubt, members of self-insured customers or Medicare or Medicaid programs.

Exclusion Criteria:

• Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Concordant with GPS Cancer Test; Patients with advanced cancer who undergo GPS Cancer testing whose therapy matches the recommendations from the NantHealth GPS Cancer Test.	Diagnostic test: NantHealth GPS Cancer Test; Quantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing.
Discordant with GPS Cancer Test; Patients with advanced cancer who undergo GPS Cancer testing whose therapy does not match the recommendations from the NantHealth GPS Cancer Test.	Diagnostic test: NantHealth GPS Cancer Test; Quantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing.
CNA controls without testing; Retrospective patients in the COTA database matched by similar characteristics (CNA matched).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on original treatment strategy for advanced cancer	To determine whether patients who are treated with therapies that are concordant with the NantHealth GPS Cancer test are able to stay on their original treatment strategy longer than patients treated with either discordant regimens or a matched Nanthealth GPS untested population.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cost of care	To determine the total 1 year cost of care for patients treated according to the results of the GPS Cancer test compared to discordant regimen treated patients or untested patients.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician behavior	To determine the frequency of change in treatment strategies pre and post GPS Cancer testing.	2 years

Collaborators and Investigators

• Sponsor: Cota Inc.
• Collaborators: Blue Cross Blue Shield; NantHealth Inc.
• Investigators: Principal Investigator: Deena Atieh Graham, MD, Hackensack Meridian Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2017
• Primary Completion (ACTUAL): June 13, 2018
• Study Completion (ACTUAL): June 13, 2018

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (ACTUAL): March 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20170327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No