Uterine Cervical NeoplasmsPhase 2NCT05492123
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
A Phase 2 study testing Nivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection and Chemoradiation in people with Uterine Cervical Neoplasms, run by Hospital Israelita Albert Einstein at 14 sites in Brazil.
Trial summary
A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Nivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection and Chemoradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 14 sitesBrazil
- Study dates
- 30 Aug 2022to 31 Mar 2028
- Phase
- Phase 2
- 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 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants older than 18 years
- Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA
- No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer
- WHO/ECOG performance status of 0-1
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
Who cannot join
- Diagnosis of small cell (neuroendocrine) histology cervical cancer
- Intent to administer a fertility-sparing treatment regimen
- Undergone a previous hysterectomy
- Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field.
- History of allogeneic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders
Show all 21Show fewer
- Uncontrolled intercurrent illness
- History of another primary malignancy and active primary immunodeficiency
- Patients with active infection
- Laboratory values that fall into:
- WBC count (WBC) < 2000/μL ;
- Neutrophil count < 1500/μL;
- Platelet count < 100 x 103/μL;
- Hemoglobin level < 9.0 g/dL;
- Serum creatinine > 1.5 x upper limit of normal (ULN) unless creatinine clearance is
- ≥ 40 mL/min (measured or calculated using the Cockcroft-Gault formula);
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): > 3.0 x ULN;
- Total bilirubin > 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN);
- Any positive test result for hepatitis B virus or hepatitis C virus that indicates the presence of the virus, for example, positive Hepatitis B surface antigen (HBsAg, Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the HCV-RNA is negative).
- Participants with a condition requiring systemic treatment or with corticosteroids (>10 mg daily of a prednisone equivalent) or other immunosuppressive drugs within 14 days of initiating study treatment.
- Pregnant or breastfeeding woman
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Brazil14 sites, 14 recruiting
- Not yet recruiting
Hospital de Amor
Barretos, São Paulo, 14784-400
Maria Fernanda Biazzotto, +55(17)3321-6638, nandabiazotto@hotmail.com
Maria Fernanca Biazzotto, MD
- Not yet recruiting
Hospital das Clinicas da UFMG
Belo Horizonte, Minas Gerais, 30130-100
Angélica Nogueira, +55(31)3307-9255, angélica.onco@uol.com.br
Angélica Nogueira, MD
- Recruiting
Universidade Federal de Roraima
Boa Vista, Roraima, 69310-000
Allex Jardim, +55(95)3224-4712, allex.j.fonseca@gmail.com
Allex Jardim, MD, PhD
- Not yet recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
Reitan Ribeiro, +55(41)3361-5195, reitanribeiro@hotmail.com
Reitan Ribeiro, MD
- Not yet recruiting
CEPON - Florianópolis
Florianópolis, Santa Catarina, 88034-000
Anne Schmitz, +55(48)3331-1553, anneschmitz@uol.com.br
Anne Schmitz, MD
- Recruiting
CRIO -Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60335-480
Eduardo Cronemberger, +55(85)3286-5934, cronmeberger.eduardo@gmail.com
Eduardo Cronemberger, MD
- Not yet recruiting
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-001
Fernanda Damian, +55(51)3320-3039, fernandadamian@yahoo.com.br
Fernanda Damian
- Recruiting
Multi Oncoclinicas Recife
Recife, Pernambuco, 50070-460
Carla Rameri, +55(81)2122-4792, carla.rameri.de.azevedo@gmail.com
Carla Rameri, MD
- Not yet recruiting
INCA - Instituto Nacional do Cancer
Rio de Janeiro, 20230-130
Adriana Melo, +55(21)3207-2985, andreia.melo@inca.gov.br
Andreia Melo, MD
- Recruiting
Clinica AMO
Salvador, Estado de Bahia, 41810-011
Aknar Calabrich, +55(71)3021-8735, aknar@clinicaamo.com.br
Aknar Calabrich
- Not yet recruiting
Hospital De Base de São José do Rio Preto - CIP São José
São José do Rio Preto, São Paulo, 15090-000
João Daniel, +55(17)3201-5054, joaodcguedes@gmail.com
João Daniel, MD
- Not yet recruiting
AC Camargo Cancer Center
São Paulo, 01509-001
Natasha Carvalho, +55(11)2189-5021, natasha.pandolfi@accamargo.org.br
Natasha Carvalho, MD
- Recruiting
Hospital Municipal Vila Santa Catarina
São Paulo, 04378-500
Ana Lucia Neves, 2151-1223 ext. 0, ana.neves@einstein.br
Henrique A Helber, MD
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, 05652-900
Fernando Maluf
Diogo Bugano, diogo.gomes@einstein.br
About this study
Official title: Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.
Read the detailed description
Patients with adenocarcinoma or squamous cell carcinoma of the cervix, FIGO Stage IB2-IB3 node positive or Stage IIB-IVA will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. Primary outcome will be 3-year progression-free survival.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Nivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection, Chemoradiation
- Keywords
- Uterine Cervical Neoplasms, Nivolumab, Ipilimumab, Chemoradiation, Anti-PD1, Anti-PDL1, Anti-CTLA4, Immunotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 40 mg in 4 ml InjectionDrug
Also called Opdivo
Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
Ipilimumab 200 MG in 40 ML InjectionDrug
Also called Yervoy
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
ChemoradiationRadiation
Also called Cisplatin-based chemoradiation
Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w
| Study group | Role | What they receive |
|---|---|---|
| Standard Chemoradiation | Active comparator | Traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week Receives: Radiation: Chemoradiation |
| Immunotherapy | Experimental | 4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks. Receives: Drug: Nivolumab 40 mg in 4 ml Injection; Drug: Ipilimumab 200 MG in 40 ML Injection; Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival
No evidence of disease recurrence/regrowth after 3 years of follow-up
Measured: 3 years
Secondary outcomes (6)
3-year overall survival
Rate of survival 3 years after the end of chemoradiation
Measured: 3 years
Objective response rate
RECIST response
Measured: 90 days after the end of chemoradiation
Response duration
Time from maximum response to disease progression
Measured: Through study completion, an average of 3 year
To evaluate health related quality of life (HRQoL): defined as the change from baseline of disease-related symptoms and quality of life of patients undergoing treatment Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Evaluate health related quality of life using the instrument EORTC QLQ-C30 v3 based on European Organization for Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 v3 questionnaire, consisting of 30 questions covering 15 domains, divided into three distinct scales: state scale global health and quality of life (it has only one domain, global health measure); functional scale (physical function, role performance, emotional function, cognitive function and social function domains); and symptom scale (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea and financial difficulties). The scores on each scale range from 0 - 100. The global and functional health scales indicate better quality of life as their score approaches 100. For the symptoms scale, the analysis is inverse, with better performance for quality of life when the scores approach the score minimum (zero).
Measured: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Evaluate health related quality of life using supplemental cervical cancer module (EORTC CX24) to evaluate patients submitted to treatment with Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer.
The EORTC - CX24 questionnaire contains 24 questions, divided into three multiple-item scales and six single-item scales, of which 11 refer to symptoms (questions 31-37, 39 and 41-43), three about body image. (questions 45-47), four questions on sexual/vaginal function (questions 50-53), one on lymphedema (question 38), one for evaluation of peripheral neuropathy (question 40), one for evaluation of menopausal symptoms (question 44) ), one on sexual concerns (question 48), one on sexual activity (question 49) and one on sexual pleasure (question 54). The answers are transformed into a score from 0 - 100 and calculated separately for each scale.
Measured: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Treatment-related toxicity
Treatment-related toxicity according to CTCAE version 4.0 (Common Toxicity Criteria for Adverse Events )
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start30 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- 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
- Prospective randomized trial, stratified by center, disease stage and type of radiation
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Brava
- Responsible party
- Sponsor
- Investigators
- Fernando Maluf, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492123
- Sponsor's protocol ID
- BRAVA- Cervical - SGPP 5031-21
- Status last verified
- Jan 2023
- First submitted
- 22 Jul 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.
PubMed 19001332Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
PubMed 31487218Santin AD, Deng W, Frumovitz M, Buza N, Bellone S, Huh W, Khleif S, Lankes HA, Ratner ES, O'Cearbhaill RE, Jazaeri AA, Birrer M. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecol Oncol. 2020 Apr;157(1):161-166. doi: 10.1016/j.ygyno.2019.12.034. Epub 2020 Jan 7.
PubMed 31924334
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05492123
- Acronym / sponsor ID
- BRAVA- Cervical - SGPP 5031-21
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Uterine Cervical Neoplasms, Nivolumab, Ipilimumab, Chemoradiation, Anti-PD1, Anti-PDL1, Anti-CTLA4, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Brava
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Aug 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.
A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.
Detailed description
Patients with adenocarcinoma or squamous cell carcinoma of the cervix, FIGO Stage IB2-IB3 node positive or Stage IIB-IVA will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. Primary outcome will be 3-year progression-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial, stratified by center, disease stage and type of radiation
| Arm | Type | Receives |
|---|---|---|
| Standard Chemoradiation | Active comparator | Radiation: ChemoradiationTraditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week |
| Immunotherapy | Experimental | Drug: Nivolumab 40 mg in 4 ml Injection, Drug: Ipilimumab 200 MG in 40 ML Injection, Radiation: Chemoradiation4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants older than 18 years
- Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA
- No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer
- WHO/ECOG performance status of 0-1
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
Key exclusion criteria (21 listed)
- Diagnosis of small cell (neuroendocrine) histology cervical cancer
- Intent to administer a fertility-sparing treatment regimen
- Undergone a previous hysterectomy
- Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field.
- History of allogeneic organ transplantation
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 |
|---|---|---|
| Nivolumab 40 mg in 4 ml InjectionAlso: OpdivoNivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation | Drug | Immunotherapy |
| Ipilimumab 200 MG in 40 ML InjectionAlso: YervoyIpilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation | Drug | Immunotherapy |
| ChemoradiationAlso: Cisplatin-based chemoradiationRadiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w | Radiation | Immunotherapy, Standard Chemoradiation |
Primary outcome
3-year progression-free survival
Time frame: 3 years
No evidence of disease recurrence/regrowth after 3 years of follow-up
6 secondary outcomes
3-year overall survival
Time frame: 3 years
Objective response rate
Time frame: 90 days after the end of chemoradiation
Response duration
Time frame: Through study completion, an average of 3 year
To evaluate health related quality of life (HRQoL): defined as the change from baseline of disease-related symptoms and quality of life of patients undergoing treatment Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Time frame: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Evaluate health related quality of life using supplemental cervical cancer module (EORTC CX24) to evaluate patients submitted to treatment with Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer.
Time frame: Baseline (time from screening - before starting treatment) and at the end of treatment (56 days after the last dose of radiotherapy).
Treatment-related toxicity
Time frame: Through study completion, an average of 3 year
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 5 Jan 2024.
- Background: PubMed 19001332Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.
- Background: PubMed 31487218Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, Lopez-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.
- Background: PubMed 31924334Santin AD, Deng W, Frumovitz M, Buza N, Bellone S, Huh W, Khleif S, Lankes HA, Ratner ES, O'Cearbhaill RE, Jazaeri AA, Birrer M. Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002). Gynecol Oncol. 2020 Apr;157(1):161-166. doi: 10.1016/j.ygyno.2019.12.034. Epub 2020 Jan 7.
- Individual participant dataSharing planned: No
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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.
Fernando Maluf, MD principal investigator
Hospital Israelita Albert Einstein
14 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 Nivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection and Chemoradiation in people with Uterine Cervical Neoplasms, run by Hospital Israelita Albert Einstein at 14 sites in Brazil.
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 21 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: looking for participants now, as of the sponsor's last update on 5 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 14 sites in Brazil. 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?
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?
Contact Diogo Bugano, MD (+55-11-2151-0240, diogo.gomes@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (time frame: 3 years). 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 NCT05492123, which also lists 3 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 5 Jan 2024.