Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic renal cell carcinoma

Outcome Measures

Primary Outcomes (1)

The co-primary endpoints are: PFS-2 (PFS-2 is defined as time from randomization to the first documented disease progression or death due to any cause, whichever occurs first, during the second line treatment with TKI); OS (OS is defined as time from randomization to death to any cause).

Secondary Outcomes (5)

Participants experiencing adverse events (AEs) and participants discontinuing study drug due to AEs according to CTCAE v.5.0.
change in the measurement of questionnaires.
Longitudinal measurement of plasma and tissue biomarkers in patients treated in the 2 arms.
Longitudinal measurement of PBMC in patients treated in the 2 arms.
mRNA in EV and PBMC in patients treated in the 2 arms.

Interventions

AXITINIBType not reported

NIVOLUMABType not reported

CABOZANTINIBType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
AXITINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
NIVOLUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry record
Formulated product
CABOZANTINIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
PEMBROLIZUMAB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
SORAFENIB
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

AXITINIB
Named ingredient: Axitinib
View registry record
NIVOLUMAB
Named ingredient: Nivolumab
View registry record
CABOZANTINIB
Named ingredient: cabozantinib
View registry record
PEMBROLIZUMAB
Named ingredient: pembrolizumab
View registry record
SORAFENIB
Named ingredient: Sorafenib
View registry record
SUNITINIB
Named ingredient: Sunitinib
View registry record
IPILIMUMAB
Named ingredient: Ipilimumab
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age > 18
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Sponsors & Collaborators

Fondazione IRCCS Istituto Nazionale Dei Tumori
Type not reportedlead

Study Sites (24)

Istituto Europeo Di Oncologia S.r.l.

Milan, 20141, Italy

Franco Nolè0257489425 franco.nole@ieo.it

Azienda Socio Sanitaria Territoriale Ovest Milanese

Legnano, 20025, Italy

Elena Farè0331449168 elena.fare@asst-ovestmi.it

Azienda Ospedaliero Universitaria Di Modena

Modena, 41124, Italy

Maria Giuseppa Vitale0594224106

Central Study Contacts

Ufficio Relazioni con il Pubblico

0223902772 urp@istitutotumori.mi.it

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

May 21, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-523903-31-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 06:38:51 UTC

Documents

D1_Protocol Signature Page_redacted

You may not qualify if:

Less than 18 years old.
Absolute contraindication to immunotherapy, including active autoimmune disease that requires systemic treatment (prednisone ≤10 mg/day is permitted).
Serious medical or psychiatric illness likely to interfere with participation in the study.
Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or administration of study treatment or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Prior radiation therapy to target lesions. Palliative radiotherapy is permitted.
Prior immunotherapy, except for adjuvant immunotherapy if completed more than 6 months prior to randomization.
Prior systemic treatment for locally advanced or metastatic renal cell carcinoma.
At screening, any ECG abnormality must be documented by the investigator as not clinically significant prior to study entry.
At screening, any ECHO or MUGA scan abnormality must be documented by the investigator as not clinically significant prior to study entry.
Receipt of other investigational drugs within 28 days prior to enrollment.
History of allogeneic tissue or solid organ transplant.
Significant cardiac disease within 6 months prior to first dose of the study intervention such as congestive heart failure New York Heart Association Class III or IV, unstable angina, myocardial infarction, cerebral vascular accident, uncontrolled cardiac arrhythmia. Medically controlled arrhythmia is permitted.
Diagnosis or treatment for another malignancy within 3 years prior to enrollment, except for complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or prostate cancer Gleason 6 (3+3).
Active and clinically significant hematuria, hematemesis, or hemoptysis within 3 weeks prior to first dose of study drug.
History of significant bleeding 3 months prior to randomization.
+8 more criteria

Sequence Strategy of Immuneoncology (IO-IO) vs IO-tyrosine kinase inhibitors (TKI) followed by TKI in metastatic renal cell carcinoma (mRCC): A randomized phase 3 study Meet uro and FICOG trial. COMBO-Seq trial.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations