Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden

NCT05611229 | Completed

• 1 other identifier: CTMT212AUS55
• Study Type: observational
• Target: 1,975
• Locations: 1 country
• Sites: 1

Brief Summary

This was an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.

Conditions

Metastatic Melanoma

Keywords

Adjuvant melanoma,; advanced melanoma,; treatment patterns and outcomes

Outcome Measures

Primary Outcomes (3)

• Proportion of patients receiving TT and IO therapy in the first-, and second-line

  To describe treatment patterns among patients prescribed with TT versus IO in both the populations.

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

• Proportion of patients switching from TT 1L therapy to IO 2L therapy

  To describe treatment patterns among patients prescribed with TT versus IO in both the populations.

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

• Proportion of patients switching from IO 1L therapy to TT 2L therapy

  To describe treatment patterns among patients prescribed with TT versus IO in both the populations.

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

Secondary Outcomes (5)

• Proportion of patients who discontinued treatment in 1L

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

• Reasons for discontinuation of treatment in 1L

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

• Time from initiation of 1L therapy to death for any reason

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020 for population 1 and 01 January 2014 to 31 May 2020 for population 2

• Time from initiation of 1L therapy to recurrence (for population 1)

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 30 August 2020)

• Time from initiation of 1L therapy to progression or death (for population 2)

  throughout the study period, approximately 6 years (i.e., 01 January 2014 to 31 May 2020)

Study Arms (2)

Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting

Included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with IO (e.g., nivo or pembro) or TT (e.g., dab+tram) on or after January 1, 2014, and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result.

Drug: Nivolumab; Drug: Pembrolizumab; Combination Product: Dabrafenib+Trametinib

Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and \<3 metastatic sites at the time of stage IV diagnosis.

Drug: Nivolumab; Drug: Pembrolizumab; Combination Product: Dabrafenib+Trametinib; Combination Product: Ipilimumab+Nivolumab; Combination Product: Vemurafenib+Cobimetinib; Combination Product: Encorafenib+Binimetinib

Interventions

Nivolumab DRUG

Nivolumab

Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting; Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Pembrolizumab DRUG

Pembrolizumab

Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting; Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Dabrafenib+Trametinib COMBINATION_PRODUCT

Dabrafenib+Trametinib

Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting; Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Ipilimumab+Nivolumab COMBINATION_PRODUCT

Ipilimumab+Nivolumab

Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Vemurafenib+Cobimetinib COMBINATION_PRODUCT

Vemurafenib+Cobimetinib

Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Encorafenib+Binimetinib COMBINATION_PRODUCT

Encorafenib+Binimetinib

Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset

You may qualify if:

• Population 1(patients treated in the adjuvant setting)
• Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x)
• Pathologic stage III on or after 2011
• Evidence of resection
• Adjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020
• At least 6 months of follow-up time (until death, end of data cut-off, loss-of-follow-up, or progressed to stage IV diagnosis) from the initiation of therapy
• Evidence of a BRAF+ result ≤30 days after therapy initiation in the adjuvant setting
• At least 18 years of age at the time of initiation of treatment
• No documented receipt of a clinical trial treatment for cancer at any time on or after January 1, 2014
• Population 2 (patients with LTB treated in the metastatic setting)
• Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x)
• Pathologic stage IV at initial diagnosis on or after 1/1/2011, or earlier stage disease accompanied by development of a first locoregional recurrence on or after 1/1/2011
• L treatment with IO (ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vemu+cobi, enco+bini) on or after 1/1/2014 and prior to 5/31/2020
• At least 6 months of follow-up time (until death, loss of follow-up, or end of data cut-off) from the initiation of therapy
• Evidence of a BRAF+ result ≤30 days after 1L therapy initiation

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for CTMT212AUS55 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Melanoma

Interventions

Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 9, 2022
• Study Start: June 16, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)