Cabozantinib Post First-line Immuno-oncology Checkpoint Inhibitor Containing Combination

NCT04957160 | Completed

• 1 other identifier: CLIN-60000-451
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 9

Brief Summary

This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.

Conditions

Advanced Renal Cell Carcinoma (aRCC)

Outcome Measures

Primary Outcomes (2)

• Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC

  To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy.

  From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

• Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC

  To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy.

  From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

Secondary Outcomes (12)

• Overall Survival (OS)

  From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

• Time to Treatment Discontinuation (TTD) by line

  From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022)

• Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease

  From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

• Overall Response Rate (ORR) by line -complete response or partial response

  From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022)

• Duration of treatment by line

  From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022)

Study Arms (2)

Cohort 1

Cohort 2

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

The study will be conducted in 10 UK hospitals that have patients who have been treated with a 1L IO containing combination therapy and have progressed to, and started, a 2L treatment.

You may qualify if:

• Patients with a diagnosis of aRCC.
• Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment.

You may not qualify if:

• Patient's hospital medical records are unavailable for review;
• Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).

Sponsors & Collaborators

• Ipsen: lead

Study Sites (9)

Beatson West of Scotland Cancer Centre

Glasgow, G12 0XH, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Barts Cancer Institute

London, E1 2ES, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Clatterbridge Road, Bebington

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Mount Vernon Cencer Centre

Welwyn Garden City, AL8 6JL, United Kingdom

Location

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: July 12, 2021
• Study Start: September 9, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

GB (9)