Trial: DESTINY-Endometrial01: A Phase III Stud…

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: March 27, 2025

Planned enrollment: 600

Trial ID: NCT06989112

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Rilvegostomig (AZD2936)

Overview

Rilvegostomig (AZD2936) is an investigational bispecific immune-checkpoint antibody being developed for solid tumors, most extensively studied in non-small-cell lung cancer (NSCLC). Clinical evidence remains preliminary and largely comes from the nonrandomized phase I/II ARTEMIDE-01 trial; randomized phase III NSCLC studies are ongoing. (pubmed.ncbi.nlm.nih.gov)

Mechanism of action

Rilvegostomig is a humanized IgG1 antibody that simultaneously targets PD-1 and TIGIT, inhibitory receptors found on T cells and natural killer cells. Dual blockade is intended to restore antitumor immune activity more effectively than inhibition of either pathway alone. Its Fc region contains three mutations designed to minimize Fc-mediated immune-effector activity. (ascopubs.org)

Efficacy

In checkpoint-inhibitor–experienced, PD-L1-positive advanced NSCLC, ARTEMIDE-01 established 750 mg intravenously every three weeks as the recommended phase II dose. Among patients treated at this dose, the objective response rate (ORR) was 5.6%, the six-month disease-control rate was 31.5%, and median progression-free survival (PFS) was 3.8 months. (pubmed.ncbi.nlm.nih.gov)

Updated results in 65 checkpoint-inhibitor–naïve patients receiving 750 mg every three weeks showed:

PD-L1 TPS 1–49%: ORR 29.0% (9/31), median duration of response 9.9 months, and median PFS 6.1 months.
PD-L1 TPS ≥50%: ORR 61.8% (21/34), including one complete response; median PFS was 12.3 months, while median duration of response was not yet reached.

These single-arm results cannot establish whether rilvegostomig is superior to currently available checkpoint inhibitors. (annalsofoncology.org)

Safety

In 83 checkpoint-inhibitor–experienced patients, 54.2% experienced a treatment-related adverse event, including 8.4% with grade 3 events; no dose-limiting toxicities were observed, and 2.4% discontinued because of treatment-related toxicity. Immune-mediated adverse events occurred in 18.1%. (pubmed.ncbi.nlm.nih.gov)

Among the 65 checkpoint-inhibitor–naïve patients in the later analysis, grade 3 treatment-related adverse events occurred in 12.3%, treatment-related discontinuations in 3.1%, and no grade 4 or 5 treatment-related events were reported. (annalsofoncology.org)

TrialFetch AI Analysis

Goal: Determine whether first-line trastuzumab deruxtecan (T-DXd) plus rilvegostomig or pembrolizumab improves progression-free survival compared with carboplatin, paclitaxel, and pembrolizumab in HER2-expressing, pMMR advanced or recurrent endometrial cancer.

Patients: Adults with centrally confirmed HER2 IHC 2+ or 3+, pMMR epithelial endometrial carcinoma and primary stage III/IV or first recurrent disease. Patients must have ECOG performance status 0–1 and no prior first-line systemic therapy; prior curative-intent chemotherapy is permitted if recurrence occurred at least 6 months later. Prior antibody–drug conjugates or checkpoint inhibitors are excluded.

Design: Multicenter, randomized, controlled, open-label, sponsor-blinded phase III trial comparing two experimental regimens with an active comparator.

Treatments: Patients receive IV T-DXd plus rilvegostomig every 3 weeks, IV T-DXd plus pembrolizumab every 3 weeks, or carboplatin, paclitaxel, and pembrolizumab every 3 weeks for 6 cycles followed by pembrolizumab maintenance every 6 weeks; the chemotherapy combination may be extended to 10 cycles at investigator discretion. T-DXd is a HER2-directed antibody–drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing tumors. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT to enhance antitumor immune activity. In a single-arm study in checkpoint-inhibitor–naïve non-small-cell lung cancer, response rates ranged from 29.0% to 61.8% by PD-L1 subgroup; these results do not establish benefit in endometrial cancer or superiority to available checkpoint inhibitors.

Outcomes: The primary endpoint is RECIST 1.1 progression-free survival by blinded independent central review. Secondary measures include overall survival, investigator-assessed progression-free survival, progression after subsequent therapy, response rate and duration, safety, pharmacokinetics, immunogenicity, patient-reported tolerability, and outcomes by HER2 expression and MMR status.

Burden on patient: Moderate to high. All arms require recurring IV treatment visits and imaging, with the experimental combinations given every 3 weeks until progression or discontinuation. Central biomarker testing requires tumor tissue, and trial assessments include blood sampling for pharmacokinetics and immunogenicity, cardiac monitoring, safety tests, and patient-reported questionnaires. An adequate existing tumor sample may meet the tissue requirement, so a new biopsy is not necessarily required.

Last updated: Sep 2026

Eligibility

Show Criteria

* Key Inclusion 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 progression occurred ≥ 6 months after last dose of chemotherapy. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.

* 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, and/or intravaginal brachytherapy. Adequate treatment washout period is required.

* 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.

* Key Exclusion Criteria:

* 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

* 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, pleural effusion 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).

* 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 (ALT) is normal and viral load is controlled.

* 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.

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Little Rock, Arkansas, 72205, United States

No email / No phone

Status: Not yet recruiting

Research Site

Duarte, California, 91010, United States

No email / No phone

Status: Not yet recruiting

Research Site

Irvine, California, 92618, United States

No email / No phone

Status: Not yet recruiting

Research Site

Orlando, Florida, 32804, United States

No email / No phone

Status: Not yet recruiting

Research Site

Ann Arbor, Michigan, 48109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Not yet recruiting

Research Site

Jackson, Mississippi, 39216, United States

No email / No phone

Status: Not yet recruiting

Research Site

Springfield, Missouri, 65804, United States

No email / No phone

Status: Not yet recruiting

Research Site

Hackensack, New Jersey, 07601, United States

No email / No phone

Status: Not yet recruiting

Research Site

Albuquerque, New Mexico, 87109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Charlotte, North Carolina, 28204, United States

No email / No phone

Status: Not yet recruiting

Research Site

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Research Site

Oklahoma City, Oklahoma, 73104, United States

No email / No phone

Status: Not yet recruiting

Research Site

Philadelphia, Pennsylvania, 19111, United States

No email / No phone

Status: Not yet recruiting

Research Site

Charleston, South Carolina, 29425, United States

No email / No phone

Status: Not yet recruiting

Research Site

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Not yet recruiting

Research Site

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Not yet recruiting

Research Site

Charleroi, 6060, Belgium

No email / No phone

Status: Withdrawn

Research Site

Winnipeg, Manitoba, R3E 0V9, Canada

No email / No phone

Status: Withdrawn

Research Site

Halifax, Nova Scotia, B3H 2Y9, Canada

No email / No phone

Status: Withdrawn

Research Site

Yibin, 610500, China

No email / No phone

Status: Withdrawn

Research Site

Ürümqi, 830000, China

No email / No phone

Status: Withdrawn

Research Site

Herlev, 2730, Denmark

No email / No phone

Status: Withdrawn

Research Site

Besançon, 25030, France

No email / No phone

Status: Withdrawn

Research Site

Marburg, 35043, Germany

No email / No phone

Status: Withdrawn

Research Site

Akashi-shi, 673-8558, Japan

No email / No phone

Status: Withdrawn

Research Site

Nijmegen, 6525 GA, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Rotterdam, 3015 GD, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Amsterdam, 1066CX, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Leiden, 2333 ZA, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Frauenfeld, 8501, Switzerland

No email / No phone

Status: Withdrawn

Research Site

Tucson, Arizona, 85704, United States

No email / No phone

Status: Withdrawn

Research Site

Palo Alto, California, 94304, United States

No email / No phone

Status: Withdrawn

Research Site

Sylmar, California, 91342, United States

No email / No phone

Status: Withdrawn

Research Site

Honolulu, Hawaii, 96813, United States

No email / No phone

Status: Withdrawn

Research Site

Worcester, Massachusetts, 01655, United States

No email / No phone

Status: Withdrawn

Research Site

Detroit, Michigan, 48201, United States

No email / No phone

Status: Withdrawn

Research Site

Las Vegas, Nevada, 89169, United States

No email / No phone

Status: Withdrawn

Research Site

New York, New York, 10016, United States

No email / No phone

Status: Withdrawn

Research Site

New York, New York, 10075, United States

No email / No phone

Status: Withdrawn

Research Site

Tulsa, Oklahoma, 74134, United States

No email / No phone

Status: Withdrawn

Research Site

Abington, Pennsylvania, 19001, United States

No email / No phone

Status: Withdrawn

Research Site

Hershey, Pennsylvania, 17033, United States

No email / No phone

Status: Withdrawn

Research Site

Seattle, Washington, 98133, United States

No email / No phone

Status: Withdrawn

Research Site

San Francisco, California, 94143, United States

No email / No phone

Status: SUSPENDED

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Rilvegostomig (AZD2936)

Overview

Mechanism of action

Efficacy

Safety

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (249)

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