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DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAstraZeneca

About this trial

DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations.

Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed).

Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.

Primary Stage IV disease (per FIGO 2023) regardless of presence of measurable disease at baseline.

Disqualifiers

History of organ transplant

Uncontrolled intercurrent illness, including, but not limited to ongoing or active known infection, serious chronic gastrointestinal conditions associated with diarrhea and active non-infectious skin disease requiring systemic treatment.

Spinal cord compression or clinically active central nervous system metastases

Participants with a medical history of myocardial infarction (MI) within 6 months before randomization, or symptomatic congestive heart failure (CHF) (NYHA Class II to IV), clinically significant arrhythmia, or cardiomyopathy of any etiology. Participants with troponin levels above ULN at screening (as defined by the manufacturer), should have a cardiologic consultation before enrollment to rule out MI

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab deruxtecan

    Drug

    Experimental therapy by intravenous infusion

  • Rilvegostomig

    Drug

    Experimental therapy by intravenous infusion

  • Pembrolizumab

    Drug

    Immunotherapy by intravenous infusion

  • Carboplatin

    Drug

    Standard of Care (SoC) chemotherapy by intravenous infusion

  • Paclitaxel

    Drug

    Standard of Care (SoC) chemotherapy by intravenous infusion

  • Docetaxel

    Drug

    Standard of Care (SoC) chemotherapy by intravenous infusion

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Arm A: T-DXd + RilvegostomigExperimental treatment 2 interventions
Group B: Arm B: T-DXd + PembrolizumabExperimental treatment 2 interventions
Group C: Arm C: Carboplatin + Paclitaxel + PembrolizumabActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS), as assessed by BICR

Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.

Time frame
Until progression or death due to any cause (assessed up to approximately 45 months).

Secondary outcomes

1

Overall Survival (OS)

Defined as the time from randomization until the date of death due to any cause.

Time frame
Until the date of death due to any cause (assessed up to approximately 70 months).
2

Progression Free Survival (PFS) as assessed by the investigator

PFS by investigator has the same attributes as estimand of PFS by BICR except tumor assessment is by the investigator.

Time frame
Until progression or death due to any cause (assessed up to approximately 70 months).
3

Time from randomization to second progression or death (PFS2)

PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.

Time frame
Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months).
4

Objective response rate (ORR), as assessed by BICR and investigator

ORR as assessed and confirmed by BICR is defined as the proportion of participants who have a complete response (CR) or partial response (PR), as determined and confirmed by BICR. ORR as assessed and confirmed by the investigator has the same attributes as estimand of ORR by BICR except tumor assessment per the investigator.

Time frame
Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months).

Other outcomes

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Daiichi Sankyo Co., Ltd.

Collaborator

GOG Foundation

Collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Source ClinicalTrials.gov
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