Metastatic Renal Cell Carcinoma (mRCC)NCT04175262

Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments

An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Pfizer at 1 site in Canada.

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 clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Renal Cell Carcinoma (mRCC)
What is being tested?: sunitinib
How many people: 102 participants
Where: 1 siteCanada
Study dates: 31 Oct 2019to 9 Mar 2020
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients with diagnosis of mRCC who initiated sunitinib as 2nd line treatment

Who may be able to join

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Diagnosed with mRCC
Received IO therapy as 1L therapy
Received sunitinib as 2L therapy
Age 18 years or over at the time of mRCC diagnosis
Actively treated at an IMDC clinical center (to avoid incomplete data)

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Calgary
Calgary, Alberta, p2n 4n2

Other trials in Canada

About this study

Official title: Clinical Effectiveness of Second-Line Sunitinib Following Immune-oncologic (IO) Therapy in Patients With Metastatic Renal Cell Carcinoma in the International Metastatic Renal Cell Carcinoma Database (IMDC)

The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.

Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Being tested: sunitinib
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.

sunitinibDrug
Patients to receive sunitinib as second line therapy for mRCC

Study groups in NCT04175262
Study group	Role	What they receive
Patients with mRCC		Patients diagnosed with metastatic RCC receiving first line (1L) combination of IOs therapies followed by Sunitinib as a second line (2L) treatment Receives: Drug: sunitinib

What is being measured

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

Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis.
Measured: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Measured: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Measured: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Measured: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (CR). As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
Measured: From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Measured: From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
Measured: From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
Measured: From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Measured: From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)

Timeline

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

31 Oct 20199 Mar 2020

First posted25 Nov 2019
Study start31 Oct 2019
Primary completion9 Mar 2020
Study completion9 Mar 2020

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 Metastatic Renal Cell Carcinoma (mRCC)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: Cohort
Time perspective: Retrospective
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04175262
Sponsor's protocol ID: A6181233
Status last verified: Mar 2021
First submitted: 21 Nov 2019
Last updated: 3 May 2023
Results posted: Yes, on ClinicalTrials.gov
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 Metastatic Renal Cell Carcinoma (mRCC) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Effectiveness of Second-Line Sunitinib Following Immune-oncologic (IO) Therapy in Patients With Metastatic Renal Cell Carcinoma in the International Metastatic Renal Cell Carcinoma Database (IMDC)
ClinicalTrials.gov ID: NCT04175262
Acronym / sponsor ID: A6181233
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Study type: Observational
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), Analysis Group, Inc.
Study start: 31 Oct 2019 (actual)
Primary completion: 9 Mar 2020 (actual)
Study completion: 9 Mar 2020 (actual)
First posted: 25 Nov 2019 (actual)
Results: Posted 2 Apr 2021

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 clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients with mRCC	–	Drug: sunitinibPatients diagnosed with metastatic RCC receiving first line (1L) combination of IOs therapies followed by Sunitinib as a second line (2L) treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with diagnosis of mRCC who initiated sunitinib as 2nd line treatment

Key inclusion criteria (6 listed)

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

Key exclusion criteria (1 listed)

None

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
sunitinibPatients to receive sunitinib as second line therapy for mRCC	Drug	Patients with mRCC

Primary outcome

Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
Time frame: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis.
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
Time frame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
Time frame: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)
TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Time frame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
Time frame: From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (CR). As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
Time frame: From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
Time frame: From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
Time frame: From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Time frame: From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)
Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib Following Immune-oncologic Therapy	102	102

Primary outcome: Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy

Time frame: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months). Median (95% Confidence Interval). Unit: Months

Measure	Sunitinib Following Immune-oncologic Therapy n = 102
Value	15.6 (9.8 to 21.7)

Population analysed: Analysis population included all eligible participants whose data was collected and analyzed in this study.

Primary outcome: Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy

Time frame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months). Median (95% Confidence Interval). Unit: Months

Measure	Sunitinib Following Immune-oncologic Therapy n = 102
Value	5.4 (4.2 to 7.2)

Population analysed: Analysis population included all eligible participants whose data was collected and analyzed in this study.

Primary outcome: Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy

Time frame: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years). Mean (Standard Deviation). Unit: Months

Measure	Sunitinib Following Immune-oncologic Therapy n = 102
Value	7.4 (8.8)

Population analysed: Analysis population included all eligible participants whose data was collected and analyzed in this study.

Primary outcome: Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation

Measure	Sunitinib Following Immune-oncologic Therapy n = 58
Disease progression	28
Toxicity	17
Death	3
Disease progression and Toxicity	1
Disease progression and Death	1
Other (urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified)	8

Population analysed: Analysis population included all eligible participants whose data was collected and analyzed in this study. Here, "Overall Number of Participants Analyzed" signifies participants who discontinued second line sunitinib treatment.

Adverse events

Time frame: Not applicable as adverse events not collected during the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib Following Immune-oncologic Therapy	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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 Metastatic Renal Cell Carcinoma (mRCC), run by Pfizer at 1 site in Canada.

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 6 inclusion and 1 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 3 May 2023. 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 Canada. 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 2 Apr 2021). 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?

Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy (time frame: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)). The study lists 9 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 NCT04175262.

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 3 May 2023.