CarcinomaPhase 3NCT03091192
Savolitinib vs. Sunitinib in MET-driven PRCC.
A Phase 3 study testing Savolitinib and Sunitinib in people with Carcinoma and Carcinoma, Renal Cell, run by AstraZeneca at 59 sites in 7 countries.
Trial summary
This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms
- What is being tested?
- Savolitinib and Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 59 sitesin 7 countries
- Study dates
- 25 Jul 2017to 31 Dec 2026
- Phase
- Phase 3
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible.
- Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay
- Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy
- Adequate haematological, renal, cardiac and liver functions
- Karnofsky performance status ≥ 80
Who cannot join
- Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <28 days from the date of randomisation. Most recent non cytotoxic targeted therapy <14 days from the date of randomisation.
- Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
- Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John's wort).
- Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation
- Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
- Previously untreated brain metastases
Show all 9Show fewer
- Serious active infection or gastrointestinal disease
- Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years.
- Mean resting QTcF >470 msec for women and >450 msec for men on the Part 2 screening triplicate ECGs or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes
Trial locations and contacts
59 sites in 7 countries.
59 sites in 7 countries
Russia13 sites
Research Site
Krasnoyarsk, 660133
Research Site
Moscow, 105077
Research Site
Moscow, 115478
Research Site
Moscow, 115522
Research Site
Moscow, RU-121356
Research Site
Murmansk, 183047
Research Site
Nizhny Novgorod, 603109
Research Site
Obninsk, 249036
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 194017
Research Site
Saint Petersburg, 195271
Research Site
Saint Petersburg, 196603
Research Site
Volgograd, 400138
Brazil11 sites
Research Site
Barretos, 14784-400
Research Site
Curitiba, 81520-060
Research Site
Passo Fundo, 99010-080
Research Site
Pelotas, 096015-280
Research Site
Porto Alegre, 90050-170
Research Site
Porto Alegre, 90610-000
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 22793-080
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01323-903
South Korea9 sites
Research Site
Daejeon, 35015
Research Site
Goyang-si, 10408
Research Site
Hwasun-gun, 58128
Research Site
Incheon, 21565
Research Site
Seoul, 03080
Research Site
Seoul, 05505
Research Site
Seoul, 06273
Research Site
Seoul, 06351
Research Site
Seoul, 120-752
United States8 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Boston, Massachusetts, 02215
Research Site
Chicago, Illinois, 60637
Research Site
Iowa City, Iowa, 52242
Research Site
Kansas City, Missouri, 64132
Research Site
La Jolla, California, 92093
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10021
Ukraine8 sites
Research Site
Dnipro, 49005
Research Site
Dnipro, 49102
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv Region, 61070
Research Site
Kyiv, 03022
Research Site
Kyiv, 03115
Research Site
Odesa, 65055
Research Site
Sumy, 40022
Italy7 sites
Research Site
Arezzo, 52100
Research Site
Meldola, 47014
Research Site
Milan, 20133
Research Site
Modena, 41100
Research Site
Orbassano, 10043
Research Site
Pavia, 27100
Research Site
Roma, 00152
France3 sites
Research Site
Bordeaux, 33000
Research Site
Vandœuvre-lès-Nancy, 54519
Research Site
Villejuif, 94805
About this study
Official title: A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)
This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.
- Conditions
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Kidney Diseases, Neoplasms by Site
- Being tested
- Savolitinib, Sunitinib
- Keywords
- Papillary Renal Cell Cancer, AZD6094, Savolitinib
- Medical subject headings
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Kidney Diseases, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SavolitinibDrug
Also called AZD6094 (HMPL-504)/Volitinib
600 mg (400 mg if <50 kg) by mouth (PO) with a meal once daily (QD), continuously
SunitinibDrug
50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off
| Study group | Role | What they receive |
|---|---|---|
| Savolitinib | Experimental | See: intervention description Receives: Drug: Savolitinib |
| Sunitinib | Active comparator | See: intervention description Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary outcomes (5)
Overall Survival (OS)
Time between the date of randomisation and the date of death due to any cause.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Objective Response Rate (ORR) by BICR
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Duration of Response (DoR) by BICR
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 6 Months by BICR
Disease control rate at 6 months is defined as the percentage of patients who have a best objective response of Complete Response or Partial Response in that period or who have demonstrated Stable Disease for a minimum interval of 23 weeks.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 12 Months by BICR
Disease control rate at 12 months is defined as the percentage of patients who have a best objective response of complete responses or partial responses in that period or who have demonstrated stable disease for a minimum interval of 47 weeks.
Measured: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start25 Jul 2017
- Primary completion18 Aug 2019
- Study completion31 Dec 2026 (estimated)
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited
- Responsible party
- Sponsor
- Investigators
- Toni K Choueiri, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091192
- Sponsor's protocol ID
- D5082C00003
- Other IDs
- 2016-004108-73, 2016
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2017
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
PubMed 32469384Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
PubMed 32203306
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)
- ClinicalTrials.gov ID
- NCT03091192
- Acronym / sponsor ID
- D5082C00003
- Conditions
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Kidney Diseases, Neoplasms by Site
- Keywords
- Papillary Renal Cell Cancer, AZD6094, Savolitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 10 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Savolitinib | Experimental | Drug: SavolitinibSee: intervention description |
| Sunitinib | Active comparator | Drug: SunitinibSee: intervention description |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible.
- Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay
- Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy
- Adequate haematological, renal, cardiac and liver functions
- Karnofsky performance status ≥ 80
Key exclusion criteria (9 listed)
- Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <28 days from the date of randomisation. Most recent non cytotoxic targeted therapy <14 days from the date of randomisation.
- Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
- Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John's wort).
- Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation
- Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
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 |
|---|---|---|
| SavolitinibAlso: AZD6094 (HMPL-504)/Volitinib600 mg (400 mg if <50 kg) by mouth (PO) with a meal once daily (QD), continuously | Drug | Savolitinib |
| Sunitinib50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off | Drug | Sunitinib |
Primary outcome
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
5 secondary outcomes
Overall Survival (OS)
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Objective Response Rate (ORR) by BICR
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Duration of Response (DoR) by BICR
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 6 Months by BICR
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 12 Months by BICR
Time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32469384Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
- Derived from this study: PubMed 32203306Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Toni K Choueiri, MD principal investigator
Dana-Farber Cancer Institute
59 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Savolitinib and Sunitinib in people with Carcinoma and Carcinoma, Renal Cell, run by AstraZeneca at 59 sites in 7 countries.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Russia, Brazil, South Korea, United States, Ukraine and 2 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2020). 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?
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (time frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.). 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 NCT03091192, which also lists 2 linked publications.
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 14 Jul 2026.