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A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

ConditionSolid Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign and date the informed consent form prior to the start of any study-specific qualification procedures.

Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.

Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.

For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen.

Disqualifiers

Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 [Part B]: seromucinous, low-grade serous carcinoma or ovarian sarcoma, carcinosarcoma and undifferentiated carcinoma are excluded.)

Major surgery <28 days

Radiation therapy <28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)

Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting study drug

Trial design

Design model

Sequential

Treatments tested in this trial

  • R-DXd

    Drug

    R-DXd will be administered as an intravenously (IV) infusion

  • Paclitaxel

    Drug

    Paclitaxel will be administered as an IV infusion

  • Topotecan

    Drug

    Topotecan will be administered as an IV infusion

  • PLD

    Drug

    PLD will be administered as an IV infusion

Treatment groups

860 Participants
are divided into 5 treatment groups
Group A: Part A: R-DXd 4.8mg/kg Q3WExperimental treatment 1 intervention
Group B: Part A: R-DXd 5.6 mg/kg Q3WExperimental treatment 1 intervention
Group C: Part A: R-DXd 6.4 mg/kg Q3WExperimental treatment 1 intervention
Group D: Part B: R-DXd RP3D Q3WExperimental treatment 1 intervention
Group E: Part B: Investigator's ChoiceActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)

The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.

Time frame
From date of randomization to data cut off, up to 18 months
2

Progression-free Survival (PFS) Based on BICR Assessment (Part B)

PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.

Time frame
From date of randomization to data cut off, up to 26 months

Secondary outcomes

1

Objective Response Rate (ORR) Based on Investigator Assessment

The ORR was defined as the percentage of participants who achieved Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), by Investigator assessment based on RECIST version 1.1.

Time frame
From date of randomization to data cut off, up to 30 months
2

Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame
From date of randomization to data cut off, up to 40 months
3

Duration of Response (DOR)

DoR is defined as the time from the date of the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame
From date of randomization to data cut off, up to 40 months
4

Progression-free Survival (PFS) Based on BICR and Investigator Assessment

PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause.

Time frame
From date of randomization to data cut off, up to 30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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