Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC

Completed

• Conditions: Renal Cell Carcinoma (RCC)
• Interventions: Drug: Tyrosine kinase inhibitor (TKI); Drug: Immuno-oncology (IO)

• Registration Number: NCT04375150
• Lead Sponsor: Pfizer

Brief Summary

The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Age 20 years or older in the year of the index first line therapy prescription.

  • 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.
  • 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)
  • Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.
  • Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data

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Exclusion Criteria

• Received advanced treatment prior to the study index date.

  • Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.
  • Only one RCC diagnosis in the 12 months prior or one mont post index date.
  • Patients with data for analysis (< 3 months post index date)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with advanced renal cell carcinoma (RCC)	Immuno-oncology (IO)	-
Patients with advanced renal cell carcinoma (RCC)	Tyrosine kinase inhibitor (TKI)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Line Treatment Regimen	At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months	Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Monotherapy and Combination Therapy	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Time to First Line Therapy	From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months	Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.
Duration of Treatment According to Each Line of Therapy	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Continuation	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Treatment continuation was considered when there was no more than (\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Interruption	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.
Time to Treatment Interruption	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Time from index medication to treatment discontinuation for those within treatment interruptions (\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants With Treatment Switch or Augmentation	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Lines of Therapy	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Number of Participants According to Their Status at End of Follow-up	At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)	Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Time to Treatment Failure (TTF)	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.
Percentage of Participants With Treatment Discontinuation	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.
Percentage of Participants Alive at 3 Months	At 3 months (data collected and observed retrospectively over 35 months)	Percentage of participants who were alive at 3 months is reported in this outcome measure.
Percentage of Participants Alive at 6 Months	At 3 months (data collected and observed retrospectively over 35 months)	Percentage of participants who were alive at 6 months is reported in this outcome measure.
Percentage of Participants Alive at 12 Months	At 3 months (data collected and observed retrospectively over 35 months)	Percentage of participants who were alive at 12 months is reported in this outcome measure.
Overall Survival	From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months	OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.

Trial Locations

Locations (1)

Pfizer INC; 🇺🇸 New York, New York, United States