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Squamous Cell Carcinoma (SCC)Phase 3NCT03257267

Study of Cemiplimab in Adults With Cervical Cancer

A Phase 3 study testing Cemiplimab and Investigator Choice (IC) Chemotherapy in people with Squamous Cell Carcinoma (SCC) and Recurrent or Metastatic, Platinum-refractory Cervical Cancer, run by Regeneron Pharmaceuticals at 105 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cemiplimab and Investigator Choice (IC) Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
105 sitesin 14 countries
Study dates
5 Sep 2017to 20 Apr 2023
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).
  • Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol
  • Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
  • Patient must have measurable disease as defined by RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • ≥18 years old
Show all 9Show fewer
  • Adequate organ or bone marrow function
  • Received prior bevacizumab therapy or had clinically documented reason why not administered
  • Received prior paclitaxel therapy or had clinically documented reason why not administered

Who cannot join

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
  • Prior treatment with other systemic immune-modulating agents that was
  • within fewer than 4 weeks (28 days) of the enrollment date, or
  • associated with irAEs of any grade within 90 days prior to enrollment, or
  • associated with toxicity that resulted in discontinuation of the immune modulating agent
Show all 13Show fewer
  • Active or untreated brain metastases
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
  • Active infection requiring therapy
  • History of pneumonitis within the last 5 years
  • History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
  • Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or death, such as adequately treated cutaneous squamous cell carcinoma or basal cell carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.
  • Note: Other protocol defined Inclusion/Exclusion apply

Trial locations and contacts

105 sites in 14 countries.

105 sites in 14 countries

Japan14 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0046

  • National Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kagoshima City Hospital

    Kagoshima, 890-8761

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8512

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8551

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0012

  • Shikoku Cancer Center

    Matsuyama, Ehime, 791-0281

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8612

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa, 903-0216

  • Saitama Medical University

    Saitama, Saitama, 350-0495

  • Saitama Cancer Center

    Saitama, Tokyo, 362-0806

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8649

  • Ehime University Hospital

    Tōon, Ehime, 791-0296

  • Fukui University Hospital

    Yoshida-gun, Fukui, 910-1194

Other trials in Japan

United States11 sites

  • Texas Oncology, P.A.

    Austin, Texas, 78745

  • New York Presbyterian Queens

    Flushing, New York, 11355

  • Northwell Health

    Lake Success, New York, 11042

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • University of California Irvine

    Orange, California, 92868

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • First Health of the Carolinas Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65804

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

Other trials in United States

Spain10 sites

  • Vall d´Hebron University Hospital

    Barcelona, 08035

  • Hospital Reina Sofia

    Córdoba, 14004

  • Instituto Catalan de Oncologia de Gerona

    Girona, 17007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario HM Sanchinarro CIOCC

    Madrid, 28050

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Universitario La Fe

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Russia9 sites

  • Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary

    Ivanovo, Ivanovo Oblast, 153040

  • State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic

    Kazan', Tatarstan Republic, 420029

  • State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region

    Krasnodar, Krasnodar Territory, 350040

  • State Budgetary Healthcare Institution "Oncology Dispensary" of Ministry of Healthcare of the Kabardino-Balkarian Republic

    Nal'chik, Kabardino-Balkarian, 360000

  • A. Tsyb Medical Radiological Research Center

    Obninsk, Kaluga Oblast, 249036

  • Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

  • State Budgetary Institution of Healthcare "Orenburg Regional Clinical Oncology Dispensary"

    Orenburg, 460021

  • Saint- Petersburg State Budgetary institution of Healthcare "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI "LROD")

    Vsevolozhsk, Leningradskaya Oblast', 188663

Other trials in Russia

Brazil8 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM

    Caxias do Sul, 95070-560

  • Centro de Novos Tratamentos Itajai

    Itajaí, Santa Catarina, 88301-220

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59075-740

  • Hosptial Sao Lucas da PUC de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 09619-900

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-072

  • Instituto Nacional de Cancer - INCA

    Rio de Janeiro, 20220-410

  • Instituto COI de Pesquisa

    Rio de Janeiro, 22793-080

Other trials in Brazil

Italy8 sites

  • Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138

  • U.O Oncologia Medica P.O Vito Fazzi

    Lecce, 73100

  • Asst Lecco

    Lecco, 23900

  • Irst Irccs

    Meldola, 47014

  • Istituto Europeo di Oncologia

    Milan, 20141

  • AUSL, IRCCS di Reggio Emilia

    Reggio Emilia, 42122

  • Fondazione Policlinico Agostino Gemelli IRCCS di Roma

    Roma, 00168

  • Regina Elena National Cancer Institute

    Rome, 00144

Other trials in Italy

Belgium7 sites

  • OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie

    Aalst, 9300

  • Institut Bordet

    Brussels, 1000

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • UZLeuven Gynaelologic Oncology

    Leuven, 3000

  • CHC Saint Joseph

    Liège, 4000

  • CHU Liège

    Liège, 4000

  • CHU UCL Namur site Sainte Elisabeth

    Namur, 5000

Other trials in Belgium

Canada7 sites

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N4N2

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Hospital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Australia6 sites

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4011

  • St. George Hospital

    Kogarah, New South Wales, 2217

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 03000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • St. John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Northern NSW Health District, The Tweed Hospital

    Tweed Heads, New South Wales, 2485

Other trials in Australia

South Korea6 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 06273

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

United Kingdom6 sites

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care

    Glasgow, G12 0YN

  • University College Hospital

    London, NW1 2BU

  • Royal Marsden NHS Foundation Trust, Chelsea

    London, SW3 6JJ

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Marsden NHS Foundation Trust, Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

Poland5 sites

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

  • Szpitale Pomorskie

    Gdynia, 81-519

  • Center and Institute of Oncology Gliwice

    Gliwice, 44-101

  • Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli

    Lublin, 20-090

  • Greater Poland Cancer Center

    Poznan, 61-866

Other trials in Poland

Greece4 sites

  • General Hospital of Athens Alexandra

    Athens, 11528

  • University Hospital of Ioannina

    Ioannina, 45110

  • General Hospital of Patras

    Pátrai, 26335

  • Euromedica General Clinic, B'Oncology Clinic

    Thessaloniki, 54645

Other trials in Greece

Taiwan4 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • MacKay Memorial Hospital

    Taipei, 10449

  • Koo-Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

Official title: An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy.

The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are:

  • To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy
  • To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
  • To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
  • To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Being tested
Cemiplimab, Investigator Choice (IC) Chemotherapy
Medical subject headings
Carcinoma, Squamous Cell, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    Intravenous (IV) administration every 3 weeks (Q3W)

  • Investigator Choice (IC) ChemotherapyDrug

    IC chemotherapy options include:

    1. Antifolate: Pemetrexed
    2. Topoisomerase 1 inhibitor: Topotecan or Irinotecan
    3. Nucleoside analogue: Gemcitabine
    4. Vinca alkaloid: Vinorelbine

    The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.

Study groups in NCT03257267
Study groupRoleWhat they receive
Experimental TherapyExperimentalCemiplimab
Receives: Drug: Cemiplimab
Control TherapyActive comparatorInvestigator choice (IC) chemotherapy
Receives: Drug: Investigator Choice (IC) Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.

    Measured: From first dose up to 90 following last dose (~42 months)

  2. Overall Survival (OS) in the SCC Population

    Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.

    Measured: From first dose up to 90 following last dose (~42 months)

Secondary outcomes (6)

  1. Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who did not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.

    Measured: Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)

  2. Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1

    ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm) (<1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From date of randomization up to 40 months

  3. Duration of Response (DOR) Assessed Per RECIST 1.1

    DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progressed while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.

    Measured: Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)

  4. Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales

    EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.

    Measured: From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death

    An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A Treatment-emergent adverse event (TEAE) was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.

    Measured: From first dose up to 90 following last dose (~36 months)

  6. Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade

    Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.

    Measured: From first dose up to 90 following last dose (~36 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start5 Sep 2017
  3. Primary completion15 Mar 2021
  4. Study completion20 Apr 2023

Resources

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
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03257267
Sponsor's protocol ID
R2810-ONC-1676
Other IDs
2017-000350-19, 2017
Status last verified
Apr 2025
First submitted
26 Jul 2017
Last updated
8 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Oaknin A, Monk BJ, Vergote I, Cristina de Melo A, Kim YM, Lisyanskaya AS, Samouelian V, Kim HS, Gotovkin EA, Damian F, Chang CL, Takahashi S, Li J, Mathias M, Fury MG, Ivanescu C, Reaney M, LaFontaine PR, Lowy I, Harnett J, Chen CI, Tewari KS. EMPOWER CERVICAL-1: Effects of cemiplimab versus chemotherapy on patient-reported quality of life, functioning and symptoms among women with recurrent cervical cancer. Eur J Cancer. 2022 Oct;174:299-309. doi: 10.1016/j.ejca.2022.03.016. Epub 2022 Jul 31.

    PubMed 35922251

  • Tewari KS, Monk BJ, Vergote I, Miller A, de Melo AC, Kim HS, Kim YM, Lisyanskaya A, Samouelian V, Lorusso D, Damian F, Chang CL, Gotovkin EA, Takahashi S, Ramone D, Pikiel J, Mackowiak-Matejczyk B, Guerra Alia EM, Colombo N, Makarova Y, Rischin D, Lheureux S, Hasegawa K, Fujiwara K, Li J, Jamil S, Jankovic V, Chen CI, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Mathias M, Fury MG, Oaknin A; Investigators for GOG Protocol 3016 and ENGOT Protocol En-Cx9. Survival with Cemiplimab in Recurrent Cervical Cancer. N Engl J Med. 2022 Feb 10;386(6):544-555. doi: 10.1056/NEJMoa2112187.

    PubMed 35139273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cemiplimab and Investigator Choice (IC) Chemotherapy in people with Squamous Cell Carcinoma (SCC) and Recurrent or Metastatic, Platinum-refractory Cervical Cancer, run by Regeneron Pharmaceuticals at 105 sites in 14 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Japan, United States, Spain, Russia, Brazil and 9 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 6 Apr 2022). 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?

Overall Survival (OS) (time frame: From first dose up to 90 following last dose (~42 months)). The study lists 2 primary outcomes in all. 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 NCT03257267, 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 8 Apr 2025.

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