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RecruitingNCT06843447Updated Oct 6, 2026

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

A Phase 1/2 interventional study of Raludotatug Deruxtecan and Carboplatin in Ovarian Cancer Recurrent, sponsored by Merck Sharp & Dohme LLC. Recruiting at 33 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Merck Sharp & Dohme LLC · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
605
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include:

  • 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.

02

Conditions studied

  • Ovarian Cancer Recurrent
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
605 participants (estimated)

Study arms

  • Experimental
    Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Carboplatin · Drug: Rescue Medication

  • Experimental
    Cohort A-1 Arm 2 (R-DXd + Paclitaxel)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Paclitaxel · Drug: Rescue Medication

  • Experimental
    Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Carboplatin · Drug: Rescue Medication

  • Experimental
    Cohort B-1 (R-DXd + Bevacizumab)

    Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.

    Biological: Raludotatug Deruxtecan · Biological: Bevacizumab · Drug: Rescue Medication

  • Experimental
    Cohort B-2 (R-DXd RP2D + Bevacizumab)

    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.

    Biological: Raludotatug Deruxtecan · Biological: Bevacizumab · Drug: Rescue Medication

  • Experimental
    Cohort C-1 (R-DXd + Pembrolizumab)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Rescue Medication · Biological: Pembrolizumab

  • Experimental
    Cohort D (R-DXd +/- Bevacizumab)

    Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation.

    Biological: Raludotatug Deruxtecan · Biological: Bevacizumab · Drug: Rescue Medication

  • Experimental
    Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Carboplatin · Biological: Bevacizumab · Drug: Rescue Medication

  • Experimental
    Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Paclitaxel · Biological: Bevacizumab · Drug: Rescue Medication

  • Active comparator
    Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab)

    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.

    Drug: Carboplatin · Drug: Paclitaxel · Biological: Bevacizumab · Drug: Gemcitabine · Drug: Pegylated liposomal doxorubicin

  • Experimental
    Cohort E-1 (R-DXd + MK-2010)

    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.

    Biological: Raludotatug Deruxtecan · Drug: Rescue Medication · Drug: MK-2010

  • Experimental
    Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab)

    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).

    Biological: Raludotatug Deruxtecan · Drug: Carboplatin · Drug: Paclitaxel · Biological: Pembrolizumab

  • Experimental
    Cohort C-2 Arm 2 (Carboplatin + Paclitaxel)

    Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation.

    Drug: Carboplatin · Drug: Paclitaxel

  • Experimental
    Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab)

    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.

    Biological: Raludotatug Deruxtecan · Biological: Bevacizumab · Biological: Pembrolizumab

Interventions

  • BiologicalRaludotatug Deruxtecan

    IV infusion on Day 1 of every 3-week cycle.

    Also known as: MK-5909, R-DXd

  • DrugCarboplatin

    IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.

  • DrugPaclitaxel

    IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.

  • BiologicalBevacizumab

    IV infusion on Day 1 of every 3-week cycle.

    Also known as: Includes, based on sourcing:, - Avastin®, - Alymsys®, - MVASI®, - Oyavas®, - Zirabev®, - Vegzelma®, - Aybintio®, - Breztri®

  • DrugRescue Medication

    Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.

  • BiologicalPembrolizumab

    IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.

  • DrugGemcitabine

    IV injection on days 1 and 8 of each 3-week Cycle

  • DrugPegylated liposomal doxorubicin

    IV injection administered on Day 1 of each 4-week cycle

    Also known as: PLD

  • DrugMK-2010

    IV infusion on Day 1 of every 3-week cycle

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to approximately 3 years

Secondary outcomes

  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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to approximately 3 years

07

Study locations

32 of 33 sites recruiting
  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
    New Haven, Connecticut 06510, United States
    • Study Coordinator · Contact · 203-785-2404
    Recruiting
  • The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
    Louisville, Kentucky 40202, United States
    • Study Coordinator · Contact · 502-562-3429
    Recruiting
  • TRIALS 365 ( Site 0020)
    Shreveport, Louisiana 71103, United States
    • Study Coordinator · Contact · 318-408-1198
    Recruiting
  • Dana-Farber Cancer Institute ( Site 0015)
    Boston, Massachusetts 02215, United States
    • Study Coordinator · Contact · 877-338-7425
    Recruiting
  • Memorial Sloan Kettering Cancer Center ( Site 0003)
    New York, New York 10065, United States
    • Study Coordinator · Contact · 212-639-2000
    Recruiting
  • OU Health University of Oklahoma Medical Center ( Site 7000)
    Oklahoma City, Oklahoma 73104, United States
    • Study Coordinator · Contact · 405-271-1112
    Recruiting
  • Texas Oncology - DFW ( Site 8000)
    Fort Worth, Texas 76104, United States
    • Study Coordinator · Contact · 615-329-7430
    Recruiting
  • Houston Methodist Hospital ( Site 0010)
    Houston, Texas 77030, United States
    Completed
  • START Mountain Region ( Site 0008)
    West Valley City, Utah 84119, United States
    • Study Coordinator · Contact · 801-907-4750
    Recruiting
  • University of Virginia Health System ( Site 0011)
    Charlottesville, Virginia 22908, United States
    • Study Coordinator · Contact · 434-924-9333
    Recruiting
  • Centre Hospitalier de l'Université de Montréal ( Site 0102)
    Montreal, Quebec H2X 0A9, Canada
    • Study Coordinator · Contact · 514-890-8000
    Recruiting
  • McGill University Health Centre ( Site 0100)
    Montreal, Quebec H4A 3J1, Canada
    • Study Coordinator · Contact · 514-934-1934x31975
    Recruiting
  • Rambam Health Care Campus ( Site 0202)
    Haifa, 3109601, Israel
    • Study Coordinator · Contact · 972-4-7776234
    Recruiting
  • Shaare Zedek Medical Center ( Site 0201)
    Jerusalem, 9103102, Israel
    • Study Coordinator · Contact · +972-(0)2-6555424
    Recruiting
  • Rabin Medical Center ( Site 0203)
    Petah Tikva, 4941492, Israel
    • Study Coordinator · Contact · +97239378076
    Recruiting
  • Sheba Medical Center ( Site 0200)
    Ramat Gan, 5265601, Israel
    • Study Coordinator · Contact · 972-3-5304498
    Recruiting
  • Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
    L'Hospitalet de Llobregat, Barcelona 08908, Spain
    • Study Coordinator · Contact · +34932607744
    Recruiting
  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)
    Majadhonda, Madrid 28222, Spain
    • Study Coordinator · Contact · +34 911917358
    Recruiting
  • Clinica Universidad de Navarra ( Site 0301)
    Madrid, Madrid, Comunidad de 28027, Spain
    • Study Coordinator · Contact · +349135319207513
    Recruiting
  • Hospital General Universitario de Valencia ( Site 0305)
    Valencia, Valenciana, Comunitat 46014, Spain
    • Study Coordinator · Contact · +34 963187527
    Recruiting
  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
    Barcelona, 08035, Spain
    • Study Coordinator · Contact · +349325434528607
    Recruiting
  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
    Madrid, 28040, Spain
    • Study Coordinator · Contact · 34915504800 x2805
    Recruiting
  • Hospital Universitario 12 de Octubre ( Site 0304)
    Madrid, 28041, Spain
    • Study Coordinator · Contact · +34913908626
    Recruiting
  • Hospital Universitario Virgen de la Victoria ( Site 0306)
    Málaga, 29010, Spain
    • Study Coordinator · Contact · +34951032508
    Recruiting
  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)
    Basel, Canton of Basel-City 4031, Switzerland
    • Study Coordinator · Contact · +41613284214
    Recruiting
  • CHUV (centre hospitalier universitaire vaudois) ( Site 0800)
    Lausanne, Canton of Vaud 1011, Switzerland
    • Study Coordinator · Contact · +41795567362
    Recruiting
  • HOCH Health Ostschweiz ( Site 0801)
    Sankt Gallen, 9000, Switzerland
    • Study Coordinator · Contact · +41714941111
    Recruiting
  • University Hospitals Sussex NHS Foundation Trust ( Site 0404)
    Brighton, East Sussex BN2 1ES, United Kingdom
    • Study Coordinator · Contact · +44 01273 696 955
    Recruiting
  • Royal Marsden Hospital ( Site 0402)
    Fulham, England SW3 6JJ, United Kingdom
    • Study Coordinator · Contact · +442078118084
    Recruiting
  • The Royal Marsden NHS Foundation Trust. ( Site 0403)
    Sutton, England SM2 5PT, United Kingdom
    • Study Coordinator · Contact · +442078118084
    Recruiting
  • Barts Health NHS Trust ( Site 0401)
    London, London, City of E1 1RD, United Kingdom
    • Study Coordinator · Contact · 020 7377 7000
    Recruiting
  • Guy s & St Thomas NHS Foundation Trust ( Site 0400)
    London, London, City of SE1 3SS, United Kingdom
    • Study Coordinator · Contact · +44 020 7188 7188
    Recruiting
  • The Christie NHS Foundation Trust ( Site 0405)
    Manchester, M20 4BX, United Kingdom
    • Study Coordinator · Contact · +441619187689
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and site details
1 update, last Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Minor edits only
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06843447
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Daiichi Sankyo
Responsible party
Sponsor
First posted
Feb 25, 2025
Start date
Apr 15, 2025
Primary completion
Mar 27, 2029 (estimated)
Completion
Feb 7, 2031 (estimated)
Last update
Oct 6, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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