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New treatment option 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?
Trastuzumab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as DS-8201a, T-DXd.
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
- 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.
- 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
- 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).
- Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet...
- 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.
You likely can't join if
- History of organ transplant
- Uncontrolled intercurrent illness, including, but not limited to ongoing or active known infection, serious chronic gastrointestinal conditions...
- 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)...
- History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by...
- Lung criteria:
See the full eligibility criteria
- 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).
- Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet at least one of the following criteria:
- 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.
- First recurrent disease regardless of presence of measurable disease at baseline.
- Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing.
- Endometrial cancer that is determined pMMR by prospective central IHC testing.
- Provision of adequate FFPE tumor tissue sample of a tumor lesion that was not previously irradiated for central HER2, MMR, and PD-L1 IHC testing and valid central test results for randomization/ stratification.
- Prior therapy:
- Naïve to first-line systemic anticancer therapy. Participants may have received one prior line of adjuvant/neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or...
- No prior exposure to ADCs or immune checkpoint inhibitors including (but not limited to) anti-PD-1/PD-L1/PD-L2 and anti-CTLA-4 antibodies and therapeutic anticancer vaccines.
- Participants may have received prior radiation therapy for the treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy...
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before randomization.
- Adequate organ and bone marrow function within 14 days before randomization.
- 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...
- 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...
- 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...
- 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).
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- Active primary immunodeficiency/ active infectious disease(s) including:
- Tuberculosis (TB)
- HIV infection that is not well controlled.
- Chronic or active hepatitis B, chronic or active hepatitis C; however, participants who have chronic hepatitis B and are receiving suppressive antiviral therapy are allowed to be enrolled if alanine aminotransferase...
- Any concurrent anticancer treatment without an adequate washout period prior to the first dose of study intervention. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., HRT) is allowed.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Sylmar, California, United States
- Fort Myers, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Augusta, Georgia, United States
- Honolulu, Hawaii, United States
- Arlington Heights, Illinois, United States
- Evanston, Illinois, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
+ 204 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 - 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?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Palo Alto, California, United States and 218 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.