Ovarian Cancer RecurrentPhase 1/2NCT06843447
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
A Phase 1/2 study testing Raludotatug Deruxtecan, Carboplatin and Paclitaxel in people with Ovarian Cancer Recurrent, run by Merck Sharp & Dohme LLC at 39 sites in 8 countries.
Trial summary
Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Recurrent
- What is being tested?
- Raludotatug Deruxtecan, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 15 Apr 2025to 7 Feb 2031
- Phase
- Phase 1/2
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
- Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1
- Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)
- Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression <6 months (<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen
- Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment
- Has provided tumor tissue for biomarker research (all cohorts)
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- Has an Eastern Cooperative Oncology Group performance status of 0 to 1
- Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting
- Participants in Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)
- Participants in Cohort C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive
- Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant
- Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant
Who cannot join
- Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
- Has uncontrolled or significant cardiovascular disease
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy
- Has ≥Grade 2 peripheral neuropathy
- Has received prior treatment with cadherin-6-targeted agents
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
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- Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Receives chronic steroid treatment
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active CNS metastases and/or carcinomatous meningitis
- Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Trial locations and contacts
39 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 8 countries
United States10 sites, 9 recruiting
- Recruiting
Dana-Farber Cancer Institute ( Site 0015)
Boston, Massachusetts, 02215
Study Coordinator, 877-338-7425
- Recruiting
University of Virginia Health System ( Site 0011)
Charlottesville, Virginia, 22908
Study Coordinator, 434-924-9333
- Recruiting
Texas Oncology - DFW ( Site 8000)
Fort Worth, Texas, 76104
Study Coordinator, 615-329-7430
- Completed
Houston Methodist Hospital ( Site 0010)
Houston, Texas, 77030
- Recruiting
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky, 40202
Study Coordinator, 502-562-3429
- Recruiting
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
New Haven, Connecticut, 06510
Study Coordinator, 203-785-2404
- Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York, 10065
Study Coordinator, 212-639-2000
- Recruiting
OU Health University of Oklahoma Medical Center ( Site 7000)
Oklahoma City, Oklahoma, 73104
Study Coordinator, 405-271-1112
- Recruiting
TRIALS 365 ( Site 0020)
Shreveport, Louisiana, 71103
Study Coordinator, 318-408-1198
- Recruiting
START Mountain Region ( Site 0008)
West Valley City, Utah, 84119
Study Coordinator, 801-907-4750
Spain8 sites, 8 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
Barcelona, 08035
Study Coordinator, +349325434528607
- Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona, 08908
Study Coordinator, +34932607744
- Recruiting
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de, 28027
Study Coordinator, +349135319207513
- Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
Madrid, 28040
Study Coordinator, 34915504800 x2805
- Recruiting
Hospital Universitario 12 de Octubre ( Site 0304)
Madrid, 28041
Study Coordinator, +34913908626
- Recruiting
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)
Majadhonda, Madrid, 28222
Study Coordinator, +34 911917358
- Recruiting
Hospital Universitario Virgen de la Victoria ( Site 0306)
Málaga, 29010
Study Coordinator, +34951032508
- Recruiting
Hospital General Universitario de Valencia ( Site 0305)
Valencia, Valenciana, Comunitat, 46014
Study Coordinator, +34 963187527
United Kingdom6 sites, 6 recruiting
- Recruiting
University Hospitals Sussex NHS Foundation Trust ( Site 0404)
Brighton, East Sussex, BN2 1ES
Study Coordinator, +44 01273 696 955
- Recruiting
Royal Marsden Hospital ( Site 0402)
Fulham, England, SW3 6JJ
Study Coordinator, +442078118084
- Recruiting
Barts Health NHS Trust ( Site 0401)
London, London, City of, E1 1RD
Study Coordinator, 020 7377 7000
- Recruiting
Guy s & St Thomas NHS Foundation Trust ( Site 0400)
London, London, City of, SE1 3SS
Study Coordinator, +44 020 7188 7188
- Recruiting
The Christie NHS Foundation Trust ( Site 0405)
Manchester, M20 4BX
Study Coordinator, +441619187689
- Recruiting
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton, England, SM2 5PT
Study Coordinator, +442078118084
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0202)
Haifa, 3109601
Study Coordinator, 972-4-7776234
- Recruiting
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, 9103102
Study Coordinator, +972-(0)2-6555424
- Recruiting
Rabin Medical Center ( Site 0203)
Petah Tikva, 4941492
Study Coordinator, +97239378076
- Recruiting
Sheba Medical Center ( Site 0200)
Ramat Gan, 5265601
Study Coordinator, 972-3-5304498
South Korea4 sites, 4 recruiting
- Recruiting
National Cancer Center ( Site 2004)
Goyang-si, Kyonggi-do, 10408
Study Coordinator, 82319201760
- Recruiting
Seoul National University Hospital ( Site 2000)
Seoul, 03080
Study Coordinator, +82220723511
- Recruiting
Severance Hospital, Yonsei University Health System ( Site 2002)
Seoul, 03722
Study Coordinator, +82222282230
- Recruiting
Asan Medical Center ( Site 2003)
Seoul, 05505
Study Coordinator, +82230103646
Canada3 sites, 3 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0102)
Montreal, Quebec, H2X 0A9
Study Coordinator, 514-890-8000
- Recruiting
McGill University Health Centre ( Site 0100)
Montreal, Quebec, H4A 3J1
Study Coordinator, 514-934-1934x31975
- Recruiting
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, M5G 2M9
Study Coordinator, 416-946-2818
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)
Basel, Canton of Basel-City, 4031
Study Coordinator, +41613284214
- Recruiting
CHUV (centre hospitalier universitaire vaudois) ( Site 0800)
Lausanne, Canton of Vaud, 1011
Study Coordinator, +41795567362
- Recruiting
HOCH Health Ostschweiz ( Site 0801)
Sankt Gallen, 9000
Study Coordinator, +41714941111
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital ( Site 3001)
Taipei, 100225
Study Coordinator, +886223123456
About this study
Official title: A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With Advanced High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian02)
Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.
Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include:
Read more
- Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing
- Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread
Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.
Read the detailed description
This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.
- Conditions
- Ovarian Cancer Recurrent
- Being tested
- Raludotatug Deruxtecan, Carboplatin, Paclitaxel, Bevacizumab, Rescue Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raludotatug DeruxtecanBiological
Also called MK-5909, R-DXd
IV infusion on Day 1 of every 3-week cycle.
CarboplatinDrug
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
PaclitaxelDrug
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
BevacizumabBiological
Also called Includes, based on sourcing:, - Avastin®, - Alymsys®, - MVASI®
IV infusion on Day 1 of every 3-week cycle.
Rescue MedicationDrug
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
PembrolizumabBiological
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
GemcitabineDrug
IV injection on days 1 and 8 of each 3-week Cycle
Pegylated liposomal doxorubicinDrug
Also called PLD
IV injection administered on Day 1 of each 4-week cycle
MK-2010Drug
IV infusion on Day 1 of every 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1) | Experimental | Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Carboplatin; Drug: Rescue Medication |
| Cohort A-1 Arm 2 (R-DXd + Paclitaxel) | Experimental | Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Paclitaxel; Drug: Rescue Medication |
| Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2) | Experimental | Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Carboplatin; Drug: Rescue Medication |
| Cohort B-1 (R-DXd + Bevacizumab) | Experimental | Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Biological: Bevacizumab; Drug: Rescue Medication |
| Cohort B-2 (R-DXd RP2D + Bevacizumab) | Experimental | Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Biological: Bevacizumab; Drug: Rescue Medication |
| Cohort C-1 (R-DXd + Pembrolizumab) | Experimental | Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Rescue Medication; Biological: Pembrolizumab |
| Cohort D (R-DXd +/- Bevacizumab) | Experimental | Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Biological: Bevacizumab; Drug: Rescue Medication |
| Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab) | Experimental | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Carboplatin; Biological: Bevacizumab; Drug: Rescue Medication |
| Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab) | Experimental | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Paclitaxel; Biological: Bevacizumab; Drug: Rescue Medication |
| Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab) | Active comparator | Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation. Receives: Drug: Carboplatin; Drug: Paclitaxel; Biological: Bevacizumab; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin |
| Cohort E-1 (R-DXd + MK-2010) | Experimental | Participants receive escalating doses of IV R-DXd in combination with MK-2010. Participants can receive up to a maximum of thirty-five 3-week cycles of MK-2010 (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. Receives: Biological: Raludotatug Deruxtecan; Drug: Rescue Medication; Drug: MK-2010 |
| Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab) | Experimental | Participants will receive carboplatin (Dose 1 or Dose 2), paclitaxel (five 3-week cycles), and pembrolizumab during the induction phase. During the maintenance phase, participants will receive RP2D of IV R-DXd (up to 2 years; participants with PR or SD at 2 years may continue until disease progression) in combination with pembrolizumab (up to thirty-five 3-week cycles). Receives: Biological: Raludotatug Deruxtecan; Drug: Carboplatin; Drug: Paclitaxel; Biological: Pembrolizumab |
| Cohort C-2 Arm 2 (Carboplatin + Paclitaxel) | Experimental | Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation. Receives: Drug: Carboplatin; Drug: Paclitaxel |
| Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab) | Experimental | Participants with PSROC will receive RP2D of R-DXd in combination with pembrolizumab (up to thirty-five 3-week cycles) and bevacizumab until progressive disease. Receives: Biological: Raludotatug Deruxtecan; Biological: Bevacizumab; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
DLTs are defined as toxicities during the DLT evaluation period that are assessed by the investigator to be possibly, probably, or definitely related to study treatment and include: Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia lasting ≥7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding; Grade 4 lymphocytopenia lasting ≥14 days; Grade 4 anemia of any duration; any other Grade 4 hematologic toxicity lasting ≥7 days; febrile neutropenia Grade 3 or Grade 4 meeting pre-specifications; pre-specified hepatic organ toxicities; all Grade 3 or higher other nonhematologic toxicities except those pre-specified; other pre-specified nonhematologic toxicities; any delay in treatment with the planned dose of ≥21 days or discontinuation of treatment due to a toxicity during the DLT evaluation period, or Grade 5 toxicity. The number of participants with DLTs will be reported.
Measured: Up to 21 days
Part 1: Number of Participants with One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs will be reported.
Measured: Up to approximately 3 years
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 3 years
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 3 years
Part 2: Progression Free Survival (PFS) - Cohort C-2 Arm 1 and Arm 2
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Measured: Up to approximately 3 years
Secondary outcomes (6)
Part 1: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1). ORR will be assessed by blinded independent central review (BICR).
Measured: Up to approximately 3 years
Part 2: Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
Measured: Up to approximately 3 years
Part 2: PFS - Cohort A-2 Arm 2 and Arm 3
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Measured: Up to approximately 3 years
Part 2: Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death due to any cause.
Measured: Up to approximately 5 years
Part 2: Number of Participants with One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 3 years
Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start15 Apr 2025
- Primary completion27 Mar 2029 (estimated)
- Study completion7 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer RecurrentStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843447
- Sponsor's protocol ID
- 5909-003
- Other IDs
- MK-5909-003, 2024-514674-47-00, U1111-1308-2821, REJOICE-Ovarian02
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf