N/A
N=102
Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
Metastatic Renal Cell Carcinoma (mRCC)
Bottom Line
View on ClinicalTrials.gov: NCT04175262 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy — 15.6 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sunitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy |
15.6 | — |
| PRIMARY Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy |
5.4 | — |
| PRIMARY Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy |
7.4 | — |
| PRIMARY Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation |
28; 17; 3; 1; 1; 8 | — |
| PRIMARY Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy |
22.5 | — |
| PRIMARY Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy |
43.7 | — |
| PRIMARY Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy |
33.8 | — |
| PRIMARY Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy |
3.1 | — |
| PRIMARY Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation |
53; 23; 1; 25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT04175262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.