Phase 3Recruiting

Comparing 3 approaches for endometrial cancer

Official title: 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

DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

Condition: Endometrial CancerSponsor: AstraZenecaTarget enrollment: 600

Phase 3
3 groups
Sites in Calgary, Edmonton and 6 more cities
Recruiting

Interventions (6)

Medication
Trastuzumab deruxtecan
Experimental therapy by intravenous infusion
Medication
Rilvegostomig
Experimental therapy by intravenous infusion
Medication
Pembrolizumab
Immunotherapy by intravenous infusion
Medication
Carboplatin
Standard of Care (SoC) chemotherapy by intravenous infusion
Medication
Paclitaxel
Standard of Care (SoC) chemotherapy by intravenous infusion
Medication
Docetaxel
Standard of Care (SoC) chemotherapy by intravenous infusion

Canadian Sites (11)

9 of 11 recruiting

Research Site
Calgary, Alberta
Recruiting
Research Site
Edmonton, Alberta
Recruiting
Research Site
London, Ontario
Recruiting
Research Site
Toronto, Ontario
Recruiting
Research Site
Toronto, Ontario
Recruiting
Research Site
Montreal, Quebec
Recruiting
Research Site
Montreal, Quebec
Recruiting
Research Site
Montreal, Quebec
Recruiting
Research Site
Québec, Quebec
Recruiting
Research Site
Winnipeg, Manitoba
Withdrawn
Research Site
Halifax, Nova Scotia
Withdrawn

See who this study is looking for32 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Participant must have primary advanced disease (Stage III/IV) or recurrent endometrial cancer and meet at least one of the following criteria:
+Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing.
+≥ 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 (per FIGO 2023) disease regardless of presence of measurable disease at baseline.
+Recurrent disease regardless of presence of measurable disease at baseline.
+Endometrial cancer that is determined pMMR by prospective central testing.
+Provision of an adequate FFPE tumor tissue sample for central HER2, MMR, and PD-L1 IHC testing.
+Prior therapy:
+No prior exposure to antibody-drug conjugates or immune checkpoint inhibitors
+Participants may have received prior hormonal therapy for the treatment of endometrial cancer. Adequate treatment washout period is required
+Left ventricular ejection fraction ≥ 50% within 28 days before randomization.
+Adequate organ and bone marrow function within 14 days before randomization.
+The participant is not considered a candidate for curative therapy in the judgment of the investigator.
+No prior chemotherapy for the treatment of EC, except for one prior line of adjuvant/ neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if completed ≥ 6 months prior to signature of the main ICF. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.
+Participants may have received prior radiation therapy for the treatment of endometrial cancer. Adequate treatment washout period is required

Exclusion

−Spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases may be included in the study.
−HIV infection that is not well controlled.
−Active hepatitis B or C infection.
−Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol.
−Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment.
−Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
−History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
−Lung criteria:
−Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, etc.).
−Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening.
−Prior pneumonectomy (complete).
−History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis.
−History of organ transplant or allogeneic stem cell transplant.
−Evidence of any of the following infections:
−Active tuberculosis

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 3 — a large study comparing this against the current standard, usually across many hospitals.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 3 groups in this study.

Group A receives Rilvegostomig, together with one or more of: Trastuzumab deruxtecan.

Registry label: A: Arm A: T-DXd + Rilvegostomig

Group B receives Pembrolizumab, together with one or more of: Trastuzumab deruxtecan.

Registry label: B: Arm B: T-DXd + Pembrolizumab

Group C, the comparison group, receives Carboplatin, Paclitaxel and Pembrolizumab, together with one or more of: Docetaxel.

Registry label: C: Arm C: Carboplatin + Paclitaxel + Pembrolizumab

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists female participants only.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 600 people.

The study is currently expected to finish around February 2031.

The main measurement is taken over: Until progression or death due to any cause (assessed up to approximately 45 months).

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Progression-free survival (PFS), as assessed by BICR — measured over Until progression or death due to any cause (assessed up to approximately 45 months).

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06989112 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?