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AzTrials

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 40 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
40 sitesin 9 countries
Study dates
15 Apr 2025to 7 Feb 2031
Phase
Phase 1/2
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 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)
Show all 12Show fewer
  • 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
Show all 13Show fewer
  • 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

40 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

40 sites in 9 countries

United States10 sites, 9 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

    Recruiting

  • Houston Methodist Hospital ( Site 0010)

    Houston, Texas, 77030

    Completed

  • 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

    Recruiting

Other trials in United States

Spain8 sites, 8 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

    Recruiting

Other trials in Spain

United Kingdom6 sites, 6 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

    Recruiting

Other trials in United Kingdom

Israel4 sites, 4 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

    Recruiting

Other trials in Israel

South Korea4 sites, 4 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

    Recruiting

Other trials in South Korea

Canada3 sites, 3 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

    Recruiting

Other trials in Canada

Switzerland3 sites, 3 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

    Recruiting

Other trials in Switzerland

Australia1 site, 1 recruiting

  • Western Health-Sunshine & Footscray Hospitals ( Site 1002)

    St Albans, Victoria, 3021

    Study Coordinator, +61402775432

    Recruiting

Other trials in Australia

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital ( Site 3001)

    Taipei, 100225

    Study Coordinator, +886223123456

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT06843447
Study groupRoleWhat they receive
Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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 comparatorParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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)ExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted25 Feb 2025
  2. Study start15 Apr 2025
  3. Primary completion27 Mar 2029 (estimated)
  4. Study completion7 Feb 2031 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
605 participants (estimated)
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
30 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Raludotatug Deruxtecan, Carboplatin and Paclitaxel in people with Ovarian Cancer Recurrent, run by Merck Sharp & Dohme LLC at 40 sites in 9 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 12 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, United Kingdom, Israel, South Korea and 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to 21 days). The study lists 5 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 NCT06843447.

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 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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