Renal Cell Carcinoma (RCC)NCT04375150

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

An observational study of Renal Cell Carcinoma (RCC), run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Renal Cell Carcinoma (RCC)
What is being tested?: Tyrosine kinase inhibitor (TKI) and Immuno-oncology (IO)
How many people: 355 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2019to 28 Oct 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients with RCC

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer INC
New York, New York, 10017

Other trials in United States

About this study

Official title: Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.

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

Conditions: Renal Cell Carcinoma (RCC)
Being tested: Tyrosine kinase inhibitor (TKI), Immuno-oncology (IO)
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tyrosine kinase inhibitor (TKI)Drug
TKIs
Immuno-oncology (IO)Drug
IOs

Study groups in NCT04375150
Study group	Role	What they receive
Patients with advanced renal cell carcinoma (RCC)		Not described Receives: Drug: Tyrosine kinase inhibitor (TKI); Drug: Immuno-oncology (IO)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With First Line Treatment Regimen
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.
Measured: 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 Monotherapy and Combination Therapy
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.
Measured: 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 to First Line Therapy
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.
Measured: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months
Duration of Treatment According to Each Line of Therapy
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.
Measured: 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 With Treatment Continuation
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.
Measured: 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 With Treatment Interruption
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.
Measured: 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 to Treatment Interruption
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.
Measured: 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 With Treatment Switch or Augmentation
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.
Measured: 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 Lines of Therapy
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.
Measured: 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 Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
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.
Measured: 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 Their Status at End of Follow-up
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.
Measured: At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)
Time to Treatment Failure (TTF)
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.
Measured: 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
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.
Measured: 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 Alive at 3 Months
Percentage of participants who were alive at 3 months is reported in this outcome measure.
Measured: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of Participants Alive at 6 Months
Percentage of participants who were alive at 6 months is reported in this outcome measure.
Measured: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of Participants Alive at 12 Months
Percentage of participants who were alive at 12 months is reported in this outcome measure.
Measured: At 3 months (data collected and observed retrospectively over 35 months)
Overall Survival
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.
Measured: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201928 Oct 2022

First posted5 May 2020
Study start2 Dec 2019
Primary completion28 Oct 2022
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 355 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04375150
Sponsor's protocol ID: A6181232
Status last verified: May 2024
First submitted: 1 May 2020
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Cell Carcinoma (RCC) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.
ClinicalTrials.gov ID: NCT04375150
Acronym / sponsor ID: A6181232
Conditions: Renal Cell Carcinoma (RCC)
Study type: Observational
Recruitment status: Completed
Enrolment: 355 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 2 Dec 2019 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 5 May 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with advanced renal cell carcinoma (RCC)	–	Drug: Tyrosine kinase inhibitor (TKI), Drug: Immuno-oncology (IO)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with RCC

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

Received advanced treatment prior to the study index date.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tyrosine kinase inhibitor (TKI)TKIs	Drug	Patients with advanced renal cell carcinoma (RCC)
Immuno-oncology (IO)IOs	Drug	Patients with advanced renal cell carcinoma (RCC)

Primary outcome

Number of Participants With First Line Treatment Regimen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axitinib + Pembrolizumab	340	340
Axitinib + Avelumab	15	15

Primary outcome: Number of Participants With First Line Treatment Regimen

Time frame: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months. Count of participants. Unit: Participants

Measure	Axitinib + Pembrolizumab n = 340	Axitinib + Avelumab n = 15
Value	340	15

Population analysed: All eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants With Monotherapy and Combination Therapy

Time frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months. Count of participants. Unit: Participants

Measure	Axitinib + Pembrolizumab n = 340	Axitinib + Avelumab n = 15
Monotherapy- First Line	0	0
Monotherapy- Second Line	97	6
Monotherapy- Third Line	21	1
Monotherapy- Fourth Line	4	1
Monotherapy- Fifth Line	5	1
Monotherapy- Sixth Line	1	–
Combination therapy- First Line	340	15
Combination therapy- Second Line	51	2

Population analysed: All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.

Primary outcome: Time to First Line Therapy

Time frame: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months. Median (Inter-Quartile Range). Unit: Days

Measure	Axitinib + Pembrolizumab n = 340	Axitinib + Avelumab n = 15
Value	29.00 (18.00 to 52.00)	25.00 (20.00 to 56.00)

Population analysed: All eligible participants whose data were retrieved and observed in this study.

Primary outcome: Duration of Treatment According to Each Line of Therapy

Time frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months. Median (Inter-Quartile Range). Unit: Days

Measure	Axitinib + Pembrolizumab n = 340	Axitinib + Avelumab n = 15
First Line Therapy	11.97 (4.85 to 22.05)	5.90 (2.80 to 16.27)
Second Line Therapy	5.38 (2.50 to 11.70)	2.58 (1.32 to 4.03)
Third Line Therapy	4.03 (2.10 to 7.03)	3.43 (1.27 to 11.33)
Fourth Line Therapy	2.75 (1.43 to 6.07)	3.57 (3.57 to 3.57)
Fifth Line Therapy	2.53 (2.37 to 3.93)	0.90 (0.90 to 0.90)
Sixth Line Therapy	4.03 (4.03 to 4.03)	–

Population analysed: All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Adverse events

Time frame: For all-cause mortality: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Axitinib + Pembrolizumab	0 of 0	0 of 0	161 of 340
Axitinib + Avelumab	0 of 0	0 of 0	11 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma (RCC), run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With First Line Treatment Regimen (time frame: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04375150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.