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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06843447




Registration number
Help: Registration number
NCT06843447
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
20/02/2025
Date registered
Help: Date registered
25/02/2025
Date last updated
Help: Date last updated
30/10/2026

Titles & IDs
Public title
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Scientific 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)
Additional trial identifiers [1] 0 0
MK-5909-003
Additional trial identifiers [2] 0 0
5909-003
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Ovarian Cancer Recurrent 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Other - Raludotatug Deruxtecan
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Other - Bevacizumab
Treatment: Drugs - Rescue Medication
Treatment: Other - Pembrolizumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Pegylated liposomal doxorubicin
Treatment: Drugs - MK-2010

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.

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.

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.

Experimental: Cohort B-1 (R-DXd + Bevacizumab) - Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.


Treatment: Other: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.

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

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

Treatment: Other: Bevacizumab
IV infusion on Day 1 of every 3-week cycle.

Treatment: Drugs: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.

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

Treatment: Drugs: Gemcitabine
IV injection on days 1 and 8 of each 3-week Cycle

Treatment: Drugs: Pegylated liposomal doxorubicin
IV injection administered on Day 1 of each 4-week cycle

Treatment: Drugs: MK-2010
IV infusion on Day 1 of every 3-week cycle
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
Part 1: Number of Participants with One or More Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 3 years
Primary outcome [3] 0 0
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
Timepoint [3] 0 0
Up to approximately 3 years
Primary outcome [4] 0 0
Part 2: Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to approximately 3 years
Primary outcome [5] 0 0
Part 2: Progression Free Survival (PFS) - Cohort C-2 Arm 1 and Arm 2
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Part 1: Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Part 2: Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Part 2: PFS - Cohort A-2 Arm 2 and Arm 3
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Part 2: Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Part 2: Number of Participants with One or More AEs
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
Timepoint [6] 0 0
Up to approximately 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/02/2031
Actual
Sample size
Target
605
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Western Health-Sunshine & Footscray Hospitals ( Site 1002) - St Albans
Recruitment postcode(s) [1] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Israel
State/province [12] 0 0
Haifa
Country [13] 0 0
Israel
State/province [13] 0 0
Jerusalem
Country [14] 0 0
Israel
State/province [14] 0 0
Petah Tikva
Country [15] 0 0
Israel
State/province [15] 0 0
Ramat Gan
Country [16] 0 0
South Korea
State/province [16] 0 0
Kyonggi-do
Country [17] 0 0
South Korea
State/province [17] 0 0
Seoul
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid, Comunidad de
Country [21] 0 0
Spain
State/province [21] 0 0
Valenciana, Comunitat
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Switzerland
State/province [23] 0 0
Canton of Basel-City
Country [24] 0 0
Switzerland
State/province [24] 0 0
Canton of Vaud
Country [25] 0 0
Switzerland
State/province [25] 0 0
Sankt Gallen
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
United Kingdom
State/province [27] 0 0
East Sussex
Country [28] 0 0
United Kingdom
State/province [28] 0 0
England
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London, City of
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://externaldatasharing-msd.com/


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06843447