Metastatic Renal Cell CarcinomaPhase 3SPICINCT05219318
Treatment Pause Versus Treatment Continuation in IMDC Good or Intermediate Risk With Only One Adverse Prognostic Factor in mRCC Patients With an Objective Response at 12 Months of Treatment With PD1/ PDL1 ICIs + VEGFR-Tyrosine Kinase Inhibitors
A Phase 3 study testing Combination PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause in people with Metastatic Renal Cell Carcinoma and Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score, run by University Hospital, Bordeaux at 26 sites in France.
Trial summary
The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response between the end of the 11th month to th end of the 13th month of treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
- What is being tested?
- Combination PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 26 sitesFrance
- Study dates
- 23 Jan 2023to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years at time of signing informed consent form
- Signed informed consent form
- Histological confirmation of RCC with a Clear-cell component, including subject who also have a sarcomatoïd feature
- Advanced (not amenable to curative surgery or radiation therapy) or Metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
- Participants with good or intermediate risk with only one adverse prognostic factor will be eligible as per International Metastatic RCC Database Consortium (IMDC) criteria
- Prior first line therapy for mRCC with the combination of PD-1/ PD-L1 ICI plus VEGFR-TKI
Show all 15Show fewer
- First line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI must be ongoing whatever the dose with no period of discontinuation > 6 consecutive weeks during treatment of the PD-1/PD-L1 ICI, and 2 consecutive weeks in the last 3 months before randomisation for the VEGFR-TKI
- Patients with an objective response (complete response or partial response) between the end of 11th month and the end of the 13th month of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI. CT scan at the initiation of this treatment must be available.
- Karnofsky Performance Status (KPS) grade ≥ 70%
- Measurable disease as per RECIST v1.1 per investigator on CT scan at the initiation of first line treatment with combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI
- Adequate organ function
- Females of childbearing potential must use a highly effective contraception (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral ; intravaginal ;transdermal) ; progestogen-only hormonal contraception associated with inhibition of ovulation (oral ; injectable ; implantable ; intrauterine device (IUD) ; intrauterine hormone-releasing system ( IUS)) ; bilateral tubal occlusion ; vasectomised partner ; sexual abstinence) and continue its use for 5 months after the last PD1/PD L1 ICI administration.
- Sexually active male patients must agree to use condoms and continue its use for 5 months after the last PD1/PD L1 ICI administration.
- Willingness and ability to comply with study procedures.
- Patient affiliated to a social security system or benefit from the same system
Who cannot join
- Prior therapy with PD-1/PD-L1 ICI or VEGFR-TKI monotherapy.
- Poorly controlled hypertension despite antihypertensive therapy
- More than one adverse prognostic factor (IMDC criteria)
- Women who are pregnant or lactating;
- Current participation in an investigational program
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Adults who are the subject of legal protection measures
- Persons deprived of their liberty by a judicial or administrative decision
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CH de la Cote Basque - Service d'Oncologie
Bayonne
CHU de Bordeaux - Service d'Oncologie
Bordeaux
Centre François Baclesse - Service d'Oncologie
Caen
Centre Jean Perrin - Service d'Oncologie
Clermont-Ferrand
AP-HP - Henri Mondor - Service d'Oncologie
Créteil
Centre Georges-François Leclerc - Service d'Oncologie
Dijon
CHU Grenoble Alpes - Service d'Oncologie
Grenoble
CHU de Limoges - Service d'Oncologie
Limoges
Polyclinique de Limoges - Service d'Oncologie
Limoges
Centre Leon Berard - Service d'Oncologie
Lyon
Hospices Civils de Lyon - Service d'Oncologie
Lyon
Institut Paoli-Calmettes - Service d'Oncologie
Marseille
Institut Régional du Cancer - Service d'Oncologie
Montpellier
Centre Antoine Lacassagne - Service d'Oncologie
Nice
AP-HP - Hôpital Européen Georges Pompidou - Service d'Oncologie
Paris
AP-HP - Hôpital Saint Louis - Service d'Oncologie
Paris
CHU de Poitiers - Service d'Oncologie
Poitiers
Centre Eugène Marquis - Service d'Oncologie
Rennes
CHU de Saint-Etienne - Service d'Oncologie
Saint-Etienne, 42055
CHU de la Réunion Site Sud - Service d'Oncologie
Saint-Pierre, 97448
Institut de cancérologie Strasbourg Europe - Service d'Oncologie
Strasbourg
Hopital Foch - Service d'Oncologie
Suresnes
IUCT Oncopole - Service d'Oncologie
Toulouse
CHU de Tours - Service d'Oncologie
Tours
Institut de Cancérologie de Lorraine - Service d'Oncologie
Vandœuvre-lès-Nancy
Institut Gustave Roussy - Service d'Oncologie
Villejuif
About this study
Official title: SPICI: Strategic Treatment Pause of First-line Immune Check Point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in Good or Only One Adverse Prognostic Factor in Intermediate Risk Metastatic Renal Cell Carcinoma (mRCC) With an Objective Response: a Randomised, Non-inferiority Phase III Study
The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response between the end of the 11th month to th end of the 13th month of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI.
Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed.
Read the detailed description
Although multiple combinations therapies in particular PD-1/PD-L1 immune-checkpoint inhibitors (PD-1/PD-L1 ICIs) in combination with vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) are approved and have improved patient's outcomes with mRCC, they are maintained until disease progression and treatment pause after an objective response has not been fully explored [5-7]. The good-risk population is characterised by prolonged survival therefore a treatment pause in this population could impact the quality of life, safety and total cost of care, without impacting outcome. As well, intermediate risk population group is heterogeneous, while the one's with only one adverse prognostic factor seems to be closed to the outcome of good risk population [11-15]. As the purpose of the study is to target patients with an objective response, there is already a selection of patients with a better outcome.
Patient will be randomised after 11 to 13 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI (treatment pause versus treatment continuation) and follow every 3 months for a period of 12 months following by 12 additional months for survival follow-up.
- Conditions
- Metastatic Renal Cell Carcinoma, Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
- Being tested
- Combination PD-1/PD-L1 ICI + VEGFR-TKI, Treatment pause
- Keywords
- Metastatic renal cell carcinoma (mRCC), Objective response, Treatment pause, Treatment continuation
- 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.
Combination PD-1/PD-L1 ICI + VEGFR-TKIDrug
The study will enroll patients achieving an objective response beween the end of the 11th month and the end of the 13th month of treatment with the combination PD-1/PD-L1 ICI + VEGFR-TKI as recommended in the Summary of Product Characteristics (SmPC)
Treatment pauseOther
Combination regimens discontinuation until progression with the possibility to resume initial combination regimens at progression
| Study group | Role | What they receive |
|---|---|---|
| Treatment pause | Experimental | Treatment pause for 12 months Receives: Other: Treatment pause |
| Treatment continuation | Active comparator | Treatment continuation regimens with PD-1/PD-L1 ICI + VEGFR-TKI until disease progression or unacceptable toxicity Receives: Drug: Combination PD-1/PD-L1 ICI + VEGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants without progression
Disease progression at up to 12 months after randomisation will be based on a blinded independent central review (BICR) according to RECIST v1.1 criteria, with tumor assessment performed every 12 weeks during study participation
Measured: Up to 12 months after randomisation
Secondary outcomes (10)
Overall safety profile and tolerability event
Proportion of participants who experience an adverse event or serious adverse event and mean number of adverse events or serious adverse events up to 12 months after randomisation
Measured: Up to 12 months after randomisation
Overall survival (OS)
OS is defined as the time between the date of randomisation and the date of death due to any cause
Measured: From randomisation until 2 years of follow-up
Progression-free survival (PFS)
PFS is defined as the time between date of randomisation and the first date of the documented disease progression, or death due to any cause, whichever occurs first
Measured: From randomisation until 2 years of follow-up
Mean change in quality of life
Measured by the NCCN functional assessment of cancer therapy-kidney symptom index (FKSI-19). The NCCN FKSI-19 is a 19-item scale that measures tumor specific health-related quality of life in kidney cancer participants. A higher score indicates fewer symptoms
Measured: Up to 12 months after randomisation
Quality-adjusted survival
The quality-adjusted time without symptoms or toxicity (Q-TWiST) is a simultaneous assessment of time without toxicity or disease progression, which essentially examines the trade-off between AEs and treatment benefits
Measured: Up to 12 months after randomisation
Anxiety and depression
Mean scores in the Hospital Anxiety and Depression Scale at up to 12 months after randomisation
Measured: Up to 12 months after randomisation
Site and distribution of the sites of progression: known lesions, new lesion(s) or both
Measured: From randomisation until 2 years of follow-up
Distribution of treatment modality after progression
Proportion of participants treated after progression with surveillance, focal treatment or general treatment
Measured: From randomisation until 2 years of follow-up
Percentage of patients with status SD or in objective response at 6 months after restarting PD-1/PD-L1 ICI + VEGFR-TKI
Measured: From randomisation until 2 years of follow-up
Healthcare resource utilisation
Costs of care will be estimated in the perspective of the French Healthcare System over a 12-month times horizon. Conventional tariffs of hospitalizations will be used to calculate costs
Measured: Up to 12 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start23 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine GROSS-GOUPIL, MD PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219318
- Sponsor's protocol ID
- CHUBX 2021/08
- Acronym
- SPICI
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPICI: Strategic Treatment Pause of First-line Immune Check Point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in Good or Only One Adverse Prognostic Factor in Intermediate Risk Metastatic Renal Cell Carcinoma (mRCC) With an Objective Response: a Randomised, Non-inferiority Phase III Study
- ClinicalTrials.gov ID
- NCT05219318
- Acronym / sponsor ID
- SPICI / CHUBX 2021/08
- Conditions
- Metastatic Renal Cell Carcinoma, Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
- Keywords
- Metastatic renal cell carcinoma (mRCC), Objective response, Treatment pause, Treatment continuation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC patients with a confirmed objective response between the end of the 11th month to th end of the 13th month of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI.
Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed.
Detailed description
Although multiple combinations therapies in particular PD-1/PD-L1 immune-checkpoint inhibitors (PD-1/PD-L1 ICIs) in combination with vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) are approved and have improved patient's outcomes with mRCC, they are maintained until disease progression and treatment pause after an objective response has not been fully explored [5-7]. The good-risk population is characterised by prolonged survival therefore a treatment pause in this population could impact the quality of life, safety and total cost of care, without impacting outcome. As well, intermediate risk population group is heterogeneous, while the one's with only one adverse prognostic factor seems to be closed to the outcome of good risk population [11-15]. As the purpose of the study is to target patients with an objective response, there is already a selection of patients with a better outcome.
Patient will be randomised after 11 to 13 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI (treatment pause versus treatment continuation) and follow every 3 months for a period of 12 months following by 12 additional months for survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment pause | Experimental | Other: Treatment pauseTreatment pause for 12 months |
| Treatment continuation | Active comparator | Drug: Combination PD-1/PD-L1 ICI + VEGFR-TKITreatment continuation regimens with PD-1/PD-L1 ICI + VEGFR-TKI until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years at time of signing informed consent form
- Signed informed consent form
- Histological confirmation of RCC with a Clear-cell component, including subject who also have a sarcomatoïd feature
- Advanced (not amenable to curative surgery or radiation therapy) or Metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
- Participants with good or intermediate risk with only one adverse prognostic factor will be eligible as per International Metastatic RCC Database Consortium (IMDC) criteria
Key exclusion criteria (8 listed)
- Prior therapy with PD-1/PD-L1 ICI or VEGFR-TKI monotherapy.
- Poorly controlled hypertension despite antihypertensive therapy
- More than one adverse prognostic factor (IMDC criteria)
- Women who are pregnant or lactating;
- Current participation in an investigational program
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 |
|---|---|---|
| Combination PD-1/PD-L1 ICI + VEGFR-TKIThe study will enroll patients achieving an objective response beween the end of the 11th month and the end of the 13th month of treatment with the combination PD-1/PD-L1 ICI + VEGFR-TKI as recommended in the Summary of Product Characteristics (SmPC) | Drug | Treatment continuation |
| Treatment pauseCombination regimens discontinuation until progression with the possibility to resume initial combination regimens at progression | Other | Treatment pause |
Primary outcome
Proportion of participants without progression
Time frame: Up to 12 months after randomisation
Disease progression at up to 12 months after randomisation will be based on a blinded independent central review (BICR) according to RECIST v1.1 criteria, with tumor assessment performed every 12 weeks during study participation
10 secondary outcomes
Overall safety profile and tolerability event
Time frame: Up to 12 months after randomisation
Overall survival (OS)
Time frame: From randomisation until 2 years of follow-up
Progression-free survival (PFS)
Time frame: From randomisation until 2 years of follow-up
Mean change in quality of life
Time frame: Up to 12 months after randomisation
Quality-adjusted survival
Time frame: Up to 12 months after randomisation
Anxiety and depression
Time frame: Up to 12 months after randomisation
Site and distribution of the sites of progression: known lesions, new lesion(s) or both
Time frame: From randomisation until 2 years of follow-up
Distribution of treatment modality after progression
Time frame: From randomisation until 2 years of follow-up
Percentage of patients with status SD or in objective response at 6 months after restarting PD-1/PD-L1 ICI + VEGFR-TKI
Time frame: From randomisation until 2 years of follow-up
Healthcare resource utilisation
Time frame: Up to 12 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
Marine GROSS-GOUPIL, MD PhD principal investigator
University Hospital, Bordeaux
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause in people with Metastatic Renal Cell Carcinoma and Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score, run by University Hospital, Bordeaux at 26 sites in France.
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 15 inclusion and 8 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants without progression (time frame: Up to 12 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.