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Ovarian NeoplasmPhase 3NCT05257408

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

A Phase 3 study testing Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2 and Nab-paclitaxel 100 mg/m^2 in people with Ovarian Neoplasm and Fallopian Tube Neoplasms, run by Corcept Therapeutics at 116 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2 and Nab-paclitaxel 100 mg/m^2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
381 participants
Where
116 sitesin 14 countries
Study dates
29 Jun 2022to Dec 2026
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

  • Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
  • Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
  • Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy).
  • Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
  • Has a life expectancy of ≥3 months.
  • At least one lesion that meets the definition of measurable disease by RECIST v1.1
Show all 13Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Able to comply with protocol requirements.
  • Able to swallow and retain oral medication and does not have uncontrolled emesis.
  • Received at least 1 but ≤3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
  • Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) ≥1500 cells/mm^3, Platelet count ≥100,000/mm^3, Hemoglobin ≥9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in context of liver metastases, Total bilirubin ≤1.5 × ULN, and Albumin ≥3 g/dL, and creatinine clearance >40 mL/min/1.73 m^2 (measured or estimated).
  • Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
  • Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.

Who cannot join

  • Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to ≤Grade 1 prior to randomization.
  • Has had any major surgery within 4 weeks prior to randomization.
  • Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
  • Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤1 month of the last dose of first-line platinum-containing chemotherapy.
  • Has not received prior bevacizumab treatment.
  • Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before first dose of study drug, radiotherapy not completed at least 2 weeks prior to first dose of study drug, hormonal anticancer therapies within 7 days of first dose of study drug, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
Show all 20Show fewer
  • Has received wide-field radiation to more than 25% of marrow-bearing areas.
  • Has toxicities of prior therapies that have not resolved by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, ≤Grade 1.
  • Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
  • Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
  • Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
  • Has peripheral neuropathy from any cause >Grade 1.
  • Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the screening visit through at least 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
  • Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
  • Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
  • Has any untreated or symptomatic central nervous system (CNS) metastases.
  • Patients with a history of other malignancy within 3 years prior to randomization.
  • Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
  • Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
  • Has received a live vaccine within 30 days prior to the study start date.

Trial locations and contacts

116 sites in 14 countries.

116 sites in 14 countries

United States44 sites

  • Site 292

    Albuquerque, New Mexico, 87131

  • Site 009

    Atlanta, Georgia, 30322

  • Site 272

    Atlanta, Georgia, 30342

  • Site 032

    Aurora, Colorado, 80045

  • Site 229

    Austin, Texas, 78731

  • Site 312

    Bedford, Texas, 76022

  • Site 337

    Bethlehem, Pennsylvania, 18015

  • Site 128

    Boston, Massachusetts, 02114

  • Site 298

    Cincinnati, Ohio, 45242

  • Site 304

    Cincinnati, Ohio, 45459

  • Site 315

    Evanston, Illinois, 60201

  • Site 275

    Flushing, New York, 11355

  • Site 297

    Fort Worth, Texas, 76104

  • Site 372

    Gainesville, Georgia, 30548

  • Site 368

    Germantown, Tennessee, 38138

  • Site 314

    Hinsdale, Illinois, 60521

  • Site 339

    Indianapolis, Indiana, 46260

  • Site 350

    Irvine, California, 92618

  • Site 364

    La Jolla, California, 92093

  • Site 279

    Louisville, Kentucky, 40241

  • Site 335

    Miami Beach, Florida, 33140

  • Site 121

    Milwaukee, Wisconsin, 53226

  • Site 281

    Nashville, Tennessee, 37203

  • Site 288

    New Brunswick, New Jersey, 08901

  • Site 300

    Norfolk, Virginia, 23502

  • Site 200

    Overland Park, Kansas, 66211

  • Site 334

    Overland Park, Kansas, 66211

  • Site 150

    Palo Alto, California, 94304

  • Site 318

    Phoenix, Arizona, 85016

  • Site 127

    Pittsburgh, Pennsylvania, 15213

  • Site 280

    Portland, Oregon, 97210

  • Site 317

    Portland, Oregon, 97213

  • Site 049

    Portland, Oregon, 97239

  • Site 276

    Rapid City, South Dakota, 57701

  • Site 365

    Richmond, Virginia, 23298

  • Site 392

    San Antonio, Texas, 78240

  • Site 278

    San Francisco, California, 94109

  • Site 014

    San Francisco, California, 94143

  • Site 291

    Savannah, Georgia, 31405

  • Site 316

    Solvang, California, 93463

  • Site 301

    The Woodlands, Texas, 77380

  • Site 277

    Tucson, Arizona, 85719

  • Site 346

    Urbana, Illinois, 61801

  • Site 042

    Weston, Florida, 33331

Other trials in United States

Brazil12 sites

  • Site 383

    Belo Horizonte, Minas Gerais, 30210-040

  • Site 424

    Brasília, Brasília - DF, 70297-400

  • Site 382

    Fortaleza, Ceará, 60170-170

  • Site 390

    Natal, Rio Grande do Norte, 59062-000

  • Site 421

    Porto Alegre, 90035-001

  • Site 380

    Rio de Janeiro, Rio de Janeiro, 22250-905

  • Site 384

    Salvador, Estado de Bahia, 41950-640

  • Site 376

    São Paulo, São Paulo, 01321001

  • Site 389

    São Paulo, São Paulo, 01327-001

  • Site 413

    São Paulo, São Paulo, 01409-002

  • Site 374

    São Paulo, São Paulo, 01509-900

  • Site 001

    São Paulo, São Paulo, 01509010

Other trials in Brazil

Argentina8 sites

  • Site 393

    CABA, Buenos Aires, C1280AEB

  • Site 381

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ANZ

  • Site 415

    Córdoba, Córdoba Province, X5004FHP

  • Site 401

    Córdoba, Córdoba Province, X5008 HHW

  • Site 395

    Córdoba, Córdoba Province, X5016

  • Site 404

    Mendoza, Mendoza Province, M5500AYB

  • Site 391

    Rosario, Santa Fe Province, 2000

  • Site 412

    Rosario, Santa Fe Province, S2000KDS

Other trials in Argentina

Italy8 sites

  • Site 321

    Catania, 95126

  • Site 320

    Legnago, 37045

  • Site 122

    Milan, 20141

  • Site 295

    Pavia, 27100

  • Site 161

    Roma, 161

  • Site 124

    Rome, 00168

  • Site 293

    Torino, 10128

  • Site 319

    Treviso, 31100

Other trials in Italy

South Korea8 sites

  • Site 397

    Gyeonggi-do, 10408

  • Site 399

    Seoul, 03080

  • Site 398

    Seoul, 03722

  • Site 403

    Seoul, 05505

  • Site 400

    Seoul, 06273

  • Site 396

    Seoul, 06351

  • Site 402

    Seoul, 08308

  • Site 409

    Seoul, 42601

Other trials in South Korea

Belgium6 sites

  • Site 328

    Aalst, 9300

  • Site 109

    Brussels, B- 1200

  • Site 326

    Charleroi, 6000

  • Site 325

    Hasselt, 3500

  • Site 108

    Leuven, 3000

  • Site 327

    Liège, B-4000

Other trials in Belgium

France6 sites

  • Site 306

    Lille, 59020

  • Site 347

    Montpellier, 34298

  • Site 307

    Nancy, 54100

  • Site 310

    Nice, 06189

  • Site 289

    Paris, 75015

  • Site 323

    Plérin, 22190

Other trials in France

United Kingdom6 sites

  • Site 367

    Brighton, East Sussex, BN2 1ES

  • Site 366

    Cheltenham, GL53 7AN

  • Site 055

    London, NW1 2PG

  • Site 344

    Manchester, M20 4BX

  • Site 345

    Northwood, HA6 2RN

  • Site 351

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Australia4 sites

  • Site 417

    Benowa, Queensland, 4217

  • Site 414

    Melbourne, Victoria, 3000

  • Site 419

    Melbourne, Victoria, 3128

  • Site 426

    St Leonards, New South Wales, 2065

Other trials in Australia

Hungary3 sites

  • Site 322

    Budapest, 1122

  • Site 290

    Debrecen, 4032

  • Site 348

    Győr, 9024

Other trials in Hungary

Israel3 sites

  • Site 309

    Haifa, 3436212

  • Site 080

    Jerusalem, 911201

  • Site 203

    Tel Aviv, 6423906

Other trials in Israel

Poland3 sites

  • Site 341

    Gdynia, 81-519

  • Site 331

    Poznan, 61-886

  • Site 329

    Siedlce, 08-110

Other trials in Poland

Spain3 sites

  • Site 349

    Badalona, 08916

  • Site 311

    San Sebastián, 20014

  • Site 330

    Valencia, 46026

Other trials in Spain

Canada2 sites

  • Site 273

    Montreal, Quebec, H4A 3J1

  • Site 117

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Read the detailed description

As there are no currently approved therapies or effective standard of care for heavily pretreated patients with ovarian cancer who have exhausted single-agent chemotherapy and/or bevacizumab, the combination of intermittently administered relacorilant and nab-paclitaxel may demonstrate a substantial improvement without increased toxicity compared with nab-paclitaxel.

Patients will receive study treatment until confirmed progressive disease (PD) or unacceptable toxicity. All patients will be followed for the collection of study endpoints, inclusive of disease progression and survival.

Being tested
Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2, Nab-paclitaxel 100 mg/m^2
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms

What participants receive

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

  • Relacorilant 150 mgDrug

    Also called Lifyorli

    Relacorilant is administered as capsules for oral dosing once daily on the day before, the day of, and the day after nab-paclitaxel administration.

  • Nab-paclitaxel 80 mg/m^2Drug

    Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.

  • Nab-paclitaxel 100 mg/m^2Drug

    Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.

Study groups in NCT05257408
Study groupRoleWhat they receive
Relacorilant 150 mg With Nab-paclitaxel 80 mg/m^2ExperimentalPatients receive nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.
Receives: Drug: Relacorilant 150 mg; Drug: Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel 100 mg/m^2Active comparatorPatients receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle.
Receives: Drug: Nab-paclitaxel 100 mg/m^2

What is being measured

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

  1. Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

    PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal progression in a non-target lesion, or the appearance of new lesions.

    Measured: Up to 20 months

  2. Overall Survival

    Overall survival (OS) was assessed as the time from randomization to death by any cause. The data values are Kaplan-Meier estimates.

    Measured: Up to 32 months

Secondary outcomes (9)

  1. PFS as Assessed by the Investigator

    PFS was assessed as the time from randomization until the time of first documented progressive disease (PD) by RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to 20 months

  2. Objective Response as Assessed by the Investigator

    Objective response was assessed as the proportion of patients with measurable disease at baseline who attained complete response (CR) or partial response (PR). Confirmation of the response was not required for this outcome measure per RECIST v1.1 criteria for randomized controlled clinical trials. Responses were assessed by imaging, using RECIST v1.1 criteria for target lesions: CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 20 months

  3. Best Overall Response as Assessed by the Investigator

    Best overall response was assessed as the proportion of patients with at least 1 post Baseline scan who attained CR, PR, stable disease (SD), or PD as best response by RECIST v1.1.

    Measured: Up to 20 months

  4. Duration of Confirmed Responses as Assessed by the Investigator

    The median duration of response is presented for confirmed responses (CR or PR) per RECIST v1.1. Duration of response was from the first documented and confirmed response to the first objectively documented PD as assessed by the Investigator, or death due to any cause, whichever occurs first.

    Measured: From the time of confirmed CR or PR to the time of the first PD or death (Up to 18 months)

  5. Clinical Benefit Rate at 24 Weeks as Assessed by BICR and the Investigator

    Clinical benefit rate was assessed as the proportion of patients who attained CR, PR, or stable disease (SD) for 24 weeks per RECIST v1.1 as assessed by BICR and as assessed by the Investigator.

    Measured: 24 weeks

  6. Cancer Antigen (CA)-125 Response

    CA-125 response was assessed per Gynecologic Cancer Intergroup (GCIG) criteria defined as ≥50% reduction in CA-125 from a pretreatment sample and maintained for ≥28 days in patients with a pretreatment sample that is at least twice the upper limit of the reference range within 2 weeks before starting the treatment. In addition, patients who have a CA-125 response and whose CA-125 level fell to within the reference range were classified as CA-125 complete responders.

    Measured: Up to 24 months

  7. Combined Overall Response Rate by RECIST v1.1 and CA-125 Defined by GCIG Criteria

    Combined response was assessed as the proportion of patients with tumor response per RECIST v1.1 assessed by the investigator and for CA-125 response per GCIG criteria.

    Measured: Up to 15 months

  8. Number of Patients With One or More Adverse Events

    Measured: Up to 22 months

  9. Number of Patients Who Discontinued the Study Treatment Due to an Adverse Event

    Measured: Up to 25 months

Timeline

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

  1. First posted25 Feb 2022
  2. Study start29 Jun 2022
  3. Primary completion31 Mar 2025
  4. Study completionDec 2026 (estimated)

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
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257408
Sponsor's protocol ID
CORT125134-556
Other IDs
ROSELLA Study 556, GOG-3073, ENGOT-OV72, APGOT-Ov10, LACOG 0223, ANZGOG2221/2023
Status last verified
Sep 2026
First submitted
4 Feb 2022
Last updated
25 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balazs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagameri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2.

    PubMed 40473448

  • Lorusso D, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Fagotti A, Gilbert L, Mileshkin L, Quesada S, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Clamp A, Prillaman C, Diakos C, Bagameri A, Leiser AL, Salutari V, Monk BJ, Follana P, McClung E, Carbone V, Slomovitz B, Giudice E, Cannizzaro MC, Gavoille L, Devaux A, Scollo P, Scandurra G, Cassani C, Artioli G, Van Gorp T, Santaballa A, Dreiling LK, Kesner-Hays A, Tudor IC, Jubb AM, Colombo N, Olawaiye AB. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026 Apr 18;407(10538):1513-1524. doi: 10.1016/S0140-6736(26)00462-9. Epub 2026 Apr 10.

    PubMed 41974149

  • Olawaiye AB, Kim JW, Bagameri A, Bishop E, Chudecka-Glaz A, Devaux A, Gladieff L, Gordinier ME, Korach J, McCollum ME, Mileshkin L, Monk BJ, Nicum S, Nogueira-Rodrigues A, Oaknin A, O'Malley DM, Orlando M, Dreiling L, Tudor IC, Lorusso D. Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer. J Gynecol Oncol. 2024 Jul;35(4):e111. doi: 10.3802/jgo.2024.35.e111.

    PubMed 39032926

  • Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, Olawaiye AB, Nguyen DD, Greenstein AE, Custodio JM, Pashova HI, Tudor IC, Lorusso D. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779-4789. doi: 10.1200/JCO.22.02624. Epub 2023 Jun 26.

    PubMed 37364223

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Relacorilant 150 mg, Nab-paclitaxel 80 mg/m^2 and Nab-paclitaxel 100 mg/m^2 in people with Ovarian Neoplasm and Fallopian Tube Neoplasms, run by Corcept Therapeutics at 116 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 13 inclusion and 20 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Brazil, Argentina, Italy, South Korea 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 25 Sep 2026). 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?

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to 20 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 NCT05257408, which also lists 4 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 25 Sep 2026.

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