Papillary Renal Cell Carcinoma Type 2Phase 2PAXIPEMNCT05096390
Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC
A Phase 2 study testing Axitinib Oral Tablet [Inlyta] and Pembrolizumab Injection [Keytruda] in people with Papillary Renal Cell Carcinoma Type 2, run by Centre Leon Berard at 12 sites in France.
Trial summary
Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Renal Cell Carcinoma Type 2
- What is being tested?
- Axitinib Oral Tablet [Inlyta] and Pembrolizumab Injection [Keytruda]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Jun 2022to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 on the day of signing informed consent.
- Metastatic or locally advanced (inoperable) type 2 or mixed PRCC, histologically confirmed by central review: FFPE blocks (or all HES and IHC slides) with the initial histology report must be sent for central reading before confirmation of inclusion in the study.
- No prior systemic treatment for renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) even in adjuvant setting.
- At least one measurable site of disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 evaluated within 7 days prior to the date of inclusion.
- In case of prior radiation therapy, discontinuation of irradiation for at least 3 weeks before first dose of study treatment, with at least 1 site kept/preserved for evaluation. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks - limited field (<10% of the whole body)) to non-CNS disease.
Show all 16Show fewer
- Adequate bone-marrow, hepatic, and renal functions within 14 days prior to the inclusion, with:
- Hemoglobin ≥ 9.0 g/dl ou ≥ 5.6 mmol/l, neutrophils ≥ 1 000/mm3 (1.0 G/l), Platelets ≥ 100 000/mm3 (100 G/l),
- Serum creatinine ≤ 2 x ULN OR creatinine clearance ≥ 50 ml/min/1.73m2 (calculated using either MDRD or CKD-EPI formula),
- AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN in case of liver metastasis),
- Total serum bilirubin ≤ 1.5 x ULN (or direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN),
- Absence of significant proteinuria (<0.5 g/24h) confirmed by urinary dipstick test. If the dipstick test is ≥ 2+, proteinuria will be quantitated on a complete 24h urine sample (< 1 g/l of protein/24h sample)
- Covered by a medical/health insurance.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patients of childbearing potential accepting to use effective contraception or abstain from heterosexual activity during study treatment and within 4 months after final dose of study therapy or being surgically sterile. Refer to Appendix 1 for approved methods of contraception.
- Signed and dated approved informed consent form before any study specific procedures or assessments.
Who cannot join
- Presence of brain metastases on Magnetic Resonance Imaging (MRI) or Computed Tomography-scan (CT-scan) performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
- Metastases with high risk of nervous compression or bone lesion with high risk of fracture.
- Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ uterine cervix carcinoma) unless the subjects has been free of the disease for at least 5 years.
- Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
- Significant cardiovascular disease, including:
- Disorder of left ventricular function with a left ventricular ejection fraction (LVEF) < 50%,
Show all 29Show fewer
- Uncontrolled arterial hypertension under adapted medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg or both despite appropriate therapy, blood pressure must be monitored and controlled before inclusion, or patients under 3 antihypertensive therapies at screening,
- Myocardial infarction, severe angina, or unstable angina within 6 months prior to inclusion,
- History of serious ventricular arrhythmia (ie ventricular tachycardia or ventricular fibrillation),
- Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication),
- Coronary or peripheral artery bypass graft or active coronary stent within 6 months prior to inclusion,
- Veinous thrombosis or pulmonary embolism within 6 months prior to inclusion.
- Any anti-coagulation therapy except prophylactic low dose.
- History of auto-immune disease except thyroiditis more than 6 months ago.
- History of any allograft.
- HIV, HBV, HCV active infections.
- Any active acute or chronic or uncontrolled infection/disorder that would impair the ability to evaluate the patient or the ability for the patient to complete the study.
- Known history of active TB (Bacillus Tuberculosis).
- Interstitial lung disease, respiratory insuffisancy whatever the cause.
- Prior (non-infectious) pneumonitis requiring systemic corticosteroid therapy or current pneumonitis.
- Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
- History of severe hypersensitivity to another monoclonal antibody.
- Known hypersensitivity to the active substances or to any of the excipients.
- Receiving or having received immunosuppressive therapy or corticosteroids within 1 month prior to inclusion (except for hydrocortisone for substitution purposes).
- Live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed if non-living/inactivated.
- Psychological, familial, sociological, or geographical conditions that would limit compliance with study protocol requirements or known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Inclusion in another clinical trial, except for supportive care trials.
- Pregnant or breastfeeding woman or patient expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 4 months after the last dose of study treatment (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).
- Under or requiring tutorship or curatorship.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
Ico - Paul Papin
Angers, 49055
Remy DELVA, MD
- Not yet recruiting
CHU de BESANCON
Besançon, 25030
Fabien CALCAGNO, MD
- Recruiting
Chu Bordeaux
Bordeaux, 33000
Marine GROSS-GOUPIL, MD
- Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Hakim MAHAMMEDI, MD
- Recruiting
Centre Leon Berard
Lyon, 69008
Sylvie NEGRIER
- Recruiting
Institut Paoli-Calmettes
Marseille, 13009
Gwenaelle GRAVIS-MESCAM, MD
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Delphine BORCHIELLINI, MD
- Not yet recruiting
Ap-Hp Hôpital Europeen Georges Pompidou
Paris, 75004
Stéphane OUDARD, PhD
- Not yet recruiting
Ico-Rene Gauducheau
Saint-Herblain, 44805
Fréderic ROLLAND, MD
- Recruiting
Iuct-Oncopole Institut Claudius Regaud
Toulouse, 31059
Christine CHEVREAU, MD
- Recruiting
Institut de Cancerologie de Lorraine - Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Lionnel GEOFFROIS, MD
- Recruiting
Gustave Roussy
Villejuif, 94805
Laurence ALBIGES, MD
About this study
Official title: Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Read the detailed description
Papillary renal cell carcinoma (PRCC) is the second most common subtype of renal carcinoma accounting for approximatively 10-15% of all renal cancers. Different types of PRCC have been described on the basis of two histologic subtypes, type 1 in 25 to 30% cases, and type 2, with a worse prognosis reported for type 2 metastatic disease. There is currently no standard of care specifically dedicated to metastatic PRCC patients (mPRCC) and treatments developed for metastatic clear cell carcinomas are commonly used ; therefore, mPRCC enrollment in clinical trials is encouraged.
Clinical trials investigated treatments such as sunitinib, or everolimus approved for advanced clear cell carcinoma, or the dual kinase inhibitor directed both towards VEGF receptors (VEGFr) and the MET pathway foretinib, or more recently, the selective MET inhibitor savolitinib. Response rates (RR) were disappointing since generally below 15%, except in a subset of patients with MET germline alterations.
Axitinib which is indicated as second-line treatment in advanced clear cell carcinoma was investigated in a recent specific trial : the Axipap trial. This multicentric phase II trial was conducted after central pathology review to confirm the histologic subtype and a central review was performed to assess the primary endpoint : the 24 week progression free rate (24wPFR). With a median follow up time of 30 months this 24wPFR was found to be over 45%. The best response rate was 28.6% according to the investigators with a median duration of response near 8 months. The investigator assessed response rate was 35.7% in the type 2 subgroup indicating a more important effect of anti-VEGFr in this subtype than in the type 1. The median PFS was around 6 months and was virtually identical in both subtypes.
Recently, some preliminary results of the use of Immune Checkpoint Inhibitors in metastatic non clear cell carcinoma were made available. The PD1 directed antibody Pembrolizumab showed a 28% response rate in 118 patients with papillary tumors including a 6% complete remission rate ; the median duration of response was of 15.3 [2.8-21.0+] months. Atezolizumb (anti-PDL1) combined with Bevacizumab and Durvalumab (anti-PDL1) combined with savolitinib (Met directed TKI) obtained response rates in the same range. These preliminary results demonstrated the potential interest of combining axitinib with an immune check point inhibitor. The results of pembrolizumab as monotherapy were obtained in the largest subset with mPRC.
According to these results obtained, the combination of axitinib and pembrolizumab seems promising in type 2 papillary tumors.
- Conditions
- Papillary Renal Cell Carcinoma Type 2
- Being tested
- Axitinib Oral Tablet [Inlyta], Pembrolizumab Injection [Keytruda]
- Keywords
- PRCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axitinib Oral Tablet [Inlyta]Drug
Axitinib 5 up to 10mg twice a day
Pembrolizumab Injection [Keytruda]Drug
Pembrolizumab intravenously over 30 min minutes at 200 mg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| axitinib + pembrolizumab | Experimental | Axitinib will be administrated orally 5 mg twice a day, with a dose adaptations to the manufacturer recommendations in both groups. Doses can be increased up to 10 mg twice daily.
Pembrolizumab will be administrated intravenously (IV) over 30 minutes at the dose of 200 mg every 3 weeks according to recent summary of product characteristics (SPC) together with axitinib. Receives: Drug: Axitinib Oral Tablet [Inlyta]; Drug: Pembrolizumab Injection [Keytruda] |
| axitinib alone (control) | Active comparator | Axitinib will be administrated orally 5 mg twice a day, with a dose adaptations to the manufacturer recommendations in both groups. Doses can be increased up to 10 mg twice daily. Receives: Drug: Axitinib Oral Tablet [Inlyta] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of axitinib + pembrolizumab versus axitinib in patients with locally advanced or metastatic type 2 papillary renal carcinoma in first-line treatment.
6-month objective response rate (6m-ORR), defined as the proportion of patients with CR or PR at 6 months
Measured: At 6 months for each patient
Secondary outcomes (5)
Duration of response (DOR)
Duration of response in each arm, calculated from the date of first documented response to the date of first documented progression or death.
Measured: Week 4, 7, 9-10, 18-19, 27-28 then Months 8, 10, 12, 14, 16, 18, 20, 22, 24
Best overall response (BOR) using RECIST 1.1
Best overall response in each arm, defined as the best response according to RECIST v1.1 recorded from baseline until the end of the study (treatment).
Measured: Up to 24 months for each patient
Progression-free survival (PFS)
PFS in each arm, defined as the time from the date of first treatment administration to the date of documented progression or death from any cause.
Measured: Up to 24 months for each patient
Overall survival (OS)
OS in each arm, defined as the time from the date of first treatment administration to the date of death from any cause.
Measured: Up to 48 months
Incidence of adverse events
Safety profile, determined using NCI CTC-AE grading scale v5
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Jun 2022
- Primary completionOct 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Renal Cell Carcinoma Type 2Studies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, prospective, phase II study
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie NEGRIER, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096390
- Sponsor's protocol ID
- PAXIPEM (ET21-023)
- Other IDs
- ET21-023
- Acronym
- PAXIPEM
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
- ClinicalTrials.gov ID
- NCT05096390
- Acronym / sponsor ID
- PAXIPEM / PAXIPEM (ET21-023)
- Conditions
- Papillary Renal Cell Carcinoma Type 2
- Keywords
- PRCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Oct 2021 (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.
Multicenter Phase II Study of Axitinib +/- Pembrolizumab in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Detailed description
Papillary renal cell carcinoma (PRCC) is the second most common subtype of renal carcinoma accounting for approximatively 10-15% of all renal cancers. Different types of PRCC have been described on the basis of two histologic subtypes, type 1 in 25 to 30% cases, and type 2, with a worse prognosis reported for type 2 metastatic disease. There is currently no standard of care specifically dedicated to metastatic PRCC patients (mPRCC) and treatments developed for metastatic clear cell carcinomas are commonly used ; therefore, mPRCC enrollment in clinical trials is encouraged.
Clinical trials investigated treatments such as sunitinib, or everolimus approved for advanced clear cell carcinoma, or the dual kinase inhibitor directed both towards VEGF receptors (VEGFr) and the MET pathway foretinib, or more recently, the selective MET inhibitor savolitinib. Response rates (RR) were disappointing since generally below 15%, except in a subset of patients with MET germline alterations.
Axitinib which is indicated as second-line treatment in advanced clear cell carcinoma was investigated in a recent specific trial : the Axipap trial. This multicentric phase II trial was conducted after central pathology review to confirm the histologic subtype and a central review was performed to assess the primary endpoint : the 24 week progression free rate (24wPFR). With a median follow up time of 30 months this 24wPFR was found to be over 45%. The best response rate was 28.6% according to the investigators with a median duration of response near 8 months. The investigator assessed response rate was 35.7% in the type 2 subgroup indicating a more important effect of anti-VEGFr in this subtype than in the type 1. The median PFS was around 6 months and was virtually identical in both subtypes.
Recently, some preliminary results of the use of Immune Checkpoint Inhibitors in metastatic non clear cell carcinoma were made available. The PD1 directed antibody Pembrolizumab showed a 28% response rate in 118 patients with papillary tumors including a 6% complete remission rate ; the median duration of response was of 15.3 [2.8-21.0+] months. Atezolizumb (anti-PDL1) combined with Bevacizumab and Durvalumab (anti-PDL1) combined with savolitinib (Met directed TKI) obtained response rates in the same range. These preliminary results demonstrated the potential interest of combining axitinib with an immune check point inhibitor. The results of pembrolizumab as monotherapy were obtained in the largest subset with mPRC.
According to these results obtained, the combination of axitinib and pembrolizumab seems promising in type 2 papillary tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, prospective, phase II study
| Arm | Type | Receives |
|---|---|---|
| axitinib + pembrolizumab | Experimental | Drug: Axitinib Oral Tablet [Inlyta], Drug: Pembrolizumab Injection [Keytruda]Axitinib will be administrated orally 5 mg twice a day, with a dose adaptations to the manufacturer recommendations in both groups. Doses can be increased up to 10 mg twice daily. Pembrolizumab will be administrated intravenously (IV) over 30 minutes at the dose of 200 mg every 3 weeks according to recent summary of product characteristics (SPC) together with axitinib. |
| axitinib alone (control) | Active comparator | Drug: Axitinib Oral Tablet [Inlyta]Axitinib will be administrated orally 5 mg twice a day, with a dose adaptations to the manufacturer recommendations in both groups. Doses can be increased up to 10 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years on the day of signing informed consent.
- Metastatic or locally advanced (inoperable) type 2 or mixed PRCC, histologically confirmed by central review: FFPE blocks (or all HES and IHC slides) with the initial histology report must be sent for central reading before confirmation of inclusion in the study.
- No prior systemic treatment for renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation) even in adjuvant setting.
- At least one measurable site of disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 evaluated within 7 days prior to the date of inclusion.
Key exclusion criteria (29 listed)
- Presence of brain metastases on Magnetic Resonance Imaging (MRI) or Computed Tomography-scan (CT-scan) performed within 28 days prior to inclusion. Patients with a history of brain metastases treated by surgery or stereotactic surgery, with normal brain MRI or CT-scan are allowed to participate.
- Metastases with high risk of nervous compression or bone lesion with high risk of fracture.
- Prior history of other malignancies other than PRCC (except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ uterine cervix carcinoma) unless the subjects has been free of the disease for at least 5 years.
- Major surgical procedure, open biopsy, or serious none healing wound within 28 days prior to inclusion.
- Significant cardiovascular disease, including:
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 |
|---|---|---|
| Axitinib Oral Tablet [Inlyta]Axitinib 5 up to 10mg twice a day | Drug | axitinib + pembrolizumab, axitinib alone (control) |
| Pembrolizumab Injection [Keytruda]Pembrolizumab intravenously over 30 min minutes at 200 mg every 3 weeks | Drug | axitinib + pembrolizumab |
Primary outcome
Efficacy of axitinib + pembrolizumab versus axitinib in patients with locally advanced or metastatic type 2 papillary renal carcinoma in first-line treatment.
Time frame: At 6 months for each patient
6-month objective response rate (6m-ORR), defined as the proportion of patients with CR or PR at 6 months
5 secondary outcomes
Duration of response (DOR)
Time frame: Week 4, 7, 9-10, 18-19, 27-28 then Months 8, 10, 12, 14, 16, 18, 20, 22, 24
Best overall response (BOR) using RECIST 1.1
Time frame: Up to 24 months for each patient
Progression-free survival (PFS)
Time frame: Up to 24 months for each patient
Overall survival (OS)
Time frame: Up to 48 months
Incidence of adverse events
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
Sylvie NEGRIER, PhD principal investigator
Centre Leon Berard
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axitinib Oral Tablet [Inlyta] and Pembrolizumab Injection [Keytruda] in people with Papillary Renal Cell Carcinoma Type 2, run by Centre Leon Berard at 12 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 16 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie NEGRIER (0478782751 ext. +33, sylvie.negrier@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of axitinib + pembrolizumab versus axitinib in patients with locally advanced or metastatic type 2 papillary renal carcinoma in first-line treatment. (time frame: At 6 months for each patient). 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 25 Jan 2024.