Clinical trial 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
ClinicalTrials.gov ID: NCT06989112
What this study is testing
What is Trastuzumab deruxtecan?
This is an investigational medicine being studied as a potential treatment for endometrial cancer. It is designed to attach to HER2 proteins on cancer cells and deliver a chemotherapy drug directly into them.
Also referred to as T-DXd, DS-8201a.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the new drug combinations keep cancer from growing longer than the usual chemotherapy plus a checkpoint drug. Progression‑free survival will be the main measure.
- Who it's for
- Women or men with advanced or recurrent endometrial cancer that shows HER2 protein on the cancer cells and has normal DNA repair (pMMR).
- What's involved
- Participants will receive either Trastuzumab Deruxtecan with rilvegostomig, Trastuzumab Deruxtecan with pembrolizumab, or the standard carboplatin and paclitaxel chemotherapy with pembrolizumab. They will have regular clinic visits and scans to monitor the cancer.
- Time commitment
- The study lasts until the cancer progresses or the participant withdraws, with visits every few weeks for treatment and periodic imaging scans.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- ≥ 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.
You likely can't join if
- Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the...
- Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease...
- Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents...
- History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by...
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli...
- Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of...
See the full eligibility criteria
- ≥ 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 with HER2 IHC expression of 3+ or 2+ by prospective central testing.
- 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.
- 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...
- No prior exposure to antibody-drug conjugates or immune checkpoint inhibitors
- Participants may have received prior radiation therapy for the treatment of endometrial cancer. Adequate treatment washout period is required
- Participants may have received prior hormonal therapy for the treatment of endometrial cancer. Adequate treatment washout period is required
- ECOG 0-1.
- 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. Key
- 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-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...
- 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...
- History of organ transplant or allogeneic stem cell transplant.
- Spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases may be included in the study.
- Active tuberculosis
- HIV infection that is not well controlled.
- Active hepatitis B or C infection.
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Fort Myers, Florida, United States
- Miami Beach, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Arlington Heights, Illinois, United States
- Evanston, Illinois, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Marshall, Minnesota, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Jackson, Mississippi, United States
- Springfield, Missouri, United States
+ 163 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Little Rock, Arkansas, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Fort Myers, Florida, United States; Miami Beach, Florida, United States and 177 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.