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 monoclonal antibody from AstraZeneca that targets PD‑1 and TIGIT. It is being studied across multiple tumor types, with ongoing phase 3 programs including first‑line metastatic non‑squamous NSCLC (ARTEMIDE‑Lung03), adjuvant biliary tract cancer after resection (ARTEMIDE‑Biliary01), first‑line advanced hepatocellular carcinoma (ARTEMIDE‑HCC01), and first‑line HER2‑positive, PD‑L1–positive gastric/GEJ cancer (ARTEMIDE‑Gastric01). (cdek.pharmacy.purdue.edu)

Mechanism of action

Bispecific IgG1 engineered to bind PD‑1 and TIGIT on the same T cell, aiming to augment antitumor immunity beyond PD‑1 blockade alone. The Fc region carries triple mutations (L234F/L235E/P331S) to reduce Fc‑mediated effector function. (cdek.pharmacy.purdue.edu)
Constructed on a DuetMab backbone; the TIGIT arm derives from Compugen’s anti‑TIGIT antibody (COM902). (cdek.pharmacy.purdue.edu)
Early clinical and translational work suggests high receptor occupancy on peripheral T cells at clinically relevant doses. (pmc.ncbi.nlm.nih.gov)

Efficacy

NSCLC (ARTEMIDE‑01, Phase I/II)

CPI‑pretreated cohort (dose escalation/expansion; PD‑L1 TPS ≥1%): among 83 patients, confirmed ORR 4.8% (all partial responses); median PFS 2.1 months (95% CI 2.0–4.1); 27‑week DCR 31.3%. Recommended phase 2 dose (RP2D) 750 mg Q3W. (oncologypro.esmo.org)
CPI‑naïve cohorts:
PD‑L1 TPS 1–49%: ORR 29%; median PFS 6.0 months (95% CI 2.7–8.4); median DOR 6.4 months (95% CI 4.2–NC). (onclive.com)
PD‑L1 TPS ≥50%: ORR 61.8% (95% CI 43.6–77.8%); median PFS 10.2 months (95% CI 6.3–NC); median DOR 10.3 months (95% CI 8.2–NC). Data are from the first analysis of ARTEMIDE‑01 CPI‑naïve parts C/D and remain preliminary. (onclive.com)

Ongoing phase 3 studies (no efficacy readouts yet)

NSCLC: ARTEMIDE‑Lung03 compares rilvegostomig + platinum/pemetrexed vs pembrolizumab + platinum/pemetrexed in first‑line PD‑L1–positive metastatic non‑squamous NSCLC (started November 2024; target n≈878). (cdek.pharmacy.purdue.edu)
Biliary tract cancer (adjuvant): ARTEMIDE‑Biliary01 evaluates rilvegostomig + investigator’s‑choice chemotherapy (capecitabine, S‑1, or gemcitabine/cisplatin) vs placebo + chemotherapy; primary endpoint recurrence‑free survival (JCO abstract TPS4199; enrollment began 2024; planned n≈750). (ascopubs.org)
Hepatocellular carcinoma: ARTEMIDE‑HCC01 compares rilvegostomig + bevacizumab with or without tremelimumab vs atezolizumab + bevacizumab in first‑line advanced HCC (registered as NCT06921785; launched 2025; planned n≈1220). (smartpatients.com)
Gastric/GEJ (HER2+, PD‑L1 CPS ≥1): ARTEMIDE‑Gastric01 (phase 3) tests rilvegostomig + fluoropyrimidine + trastuzumab deruxtecan vs trastuzumab + chemotherapy + pembrolizumab (3‑arm design; recruiting). (cdek.pharmacy.purdue.edu)

Safety

CPI‑pretreated NSCLC (ARTEMIDE‑01 parts A/B): treatment‑related AEs in 54.2% (grade ≥3 in 8.4%); no grade 4/5 treatment‑related AEs; discontinuations 3.6%. (oncologypro.esmo.org)
CPI‑naïve NSCLC (ARTEMIDE‑01 parts C/D): grade ≥3 treatment‑related AEs 10.5%; treatment‑related discontinuations 4.2%; no clear safety differences between 750 mg and 1500 mg Q3W. (onclive.com)

Key trials (selection)

Phase I/II first‑in‑human NSCLC: ARTEMIDE‑01 (NCT04995523). (cdek.pharmacy.purdue.edu)
Phase III first‑line NSCLC: ARTEMIDE‑Lung03 (NCT06627647). (cdek.pharmacy.purdue.edu)
Phase III adjuvant BTC: ARTEMIDE‑Biliary01 (NCT06109779). (ascopubs.org)
Phase III first‑line HCC: ARTEMIDE‑HCC01 (NCT06921785). (smartpatients.com)
Phase III first‑line HER2+ gastric/GEJ: ARTEMIDE‑Gastric01 (NCT06764875). (cdek.pharmacy.purdue.edu)

HealthScout AI Analysis

Goal: Evaluate whether first-line trastuzumab deruxtecan (T-DXd) combined with a PD-1/TIGIT bispecific (rilvegostomig) or with pembrolizumab improves progression-free survival versus standard carboplatin/paclitaxel plus pembrolizumab in HER2-expressing, pMMR primary advanced or recurrent endometrial cancer.

Patients: Adults with histologically confirmed epithelial endometrial carcinoma (all histologies except sarcomas; carcinosarcomas allowed) that is HER2 IHC 3+ or 2+ and pMMR by central testing. Eligible disease states include primary Stage III with measurable disease, primary Stage IV, or first recurrence, regardless of measurability. Prior neoadjuvant/adjuvant chemotherapy is allowed if disease-free interval ≥6 months; prior trastuzumab in the curative setting allowed. No prior antibody–drug conjugates or checkpoint inhibitors. ECOG 0–1, LVEF ≥50%, adequate organ function. Key exclusions include active/untreated CNS disease, recent MI/clinically significant cardiac disease, history or suspicion of ILD/pneumonitis, significant pulmonary comorbidity, active autoimmune disease requiring immunosuppression, uncontrolled infections including uncontrolled HIV or active HBV/HCV.

Design: Multicenter, open-label but sponsor-blinded, randomized, controlled Phase III trial enrolling approximately 600 patients. Randomization to one of three arms with central confirmation of HER2 and MMR status; stratification includes biomarker-based factors. Treatment continues until RECIST 1.1 progression confirmed by BICR or other discontinuation criteria. Primary endpoint assessed by blinded independent central review.

Treatments: Arm A: T-DXd plus rilvegostomig IV every 3 weeks. Rilvegostomig (AZD2936) is an investigational bispecific humanized IgG1 antibody targeting PD-1 and TIGIT, designed with Fc silencing to minimize effector function. In Phase I (ARTEMIDE-01) across heavily pretreated NSCLC, rilvegostomig showed manageable toxicity (mostly grade 1–3 pruritus/rash/lipase increases), dose-proportional PK, high PD-1/TIGIT receptor occupancy at ≥210 mg, and preliminary antitumor activity with confirmed partial responses; the recommended Phase 2 dose is 750 mg Q3W. By dual checkpoint blockade, the drug aims to enhance T-cell activation beyond PD-1 inhibition alone. Arm B: T-DXd plus pembrolizumab IV every 3 weeks. T-DXd is a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd) with bystander effect; it is approved in several HER2-expressing solid tumors and has demonstrated activity in gynecologic cancers, including endometrial cancer subsets, with known risks of ILD/pneumonitis and cytopenias. Arm C: Carboplatin plus paclitaxel plus pembrolizumab every 3 weeks for 6 cycles (option to extend to 10), followed by pembrolizumab maintenance every 6 weeks to a total of ~24 months. Docetaxel may substitute for paclitaxel after hypersensitivity.

Outcomes: Primary: PFS by BICR per RECIST 1.1. Key secondary endpoints include overall survival; investigator-assessed PFS; PFS2; ORR and DoR by BICR and investigator; safety and tolerability; pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd, and rilvegostomig; anti-drug antibodies; patient-reported symptomatic adverse events and side-effect bother. Exploratory clinical utility analyses will evaluate PFS and OS by MMR and by level of HER2 expression.

Burden on patient: Moderate. Requirements include provision of adequate archival or new FFPE tumor tissue for central HER2, MMR, and PD-L1 testing, baseline and serial imaging per RECIST with BICR confirmation, and routine safety assessments (labs, ECG, echocardiogram/MUGA for LVEF). Experimental arms involve IV infusions every 3 weeks, with added pharmacokinetic and immunogenicity blood sampling that increases visit time and blood draw frequency versus standard care. The control arm requires combination chemoimmunotherapy every 3 weeks for up to 6–10 cycles and maintenance pembrolizumab every 6 weeks thereafter. There is additional monitoring for ADC-related ILD/pneumonitis and cardiotoxicity, necessitating prompt evaluation of respiratory symptoms and periodic cardiac assessments, which can increase clinic visits. Overall, visit frequency and testing are greater than routine practice but typical for a Phase III first-line study using IV agents with safety monitoring and PK sampling.

Last updated: Oct 2025

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.

Sites (244)

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Blacktown, 2148, Australia

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Wuhan, 430000, China

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Tianjin, 300060, China

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Shanghai, 200011, China

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Nanning, 530021, China

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Nanchang, 330006, China

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Lanzhou, 730030, China

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Haikou, 570311, China

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Fuzhou, 350001, China

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Chongqing, 400030, China

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Chengdu, 610072, China

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Debrecen, 4032, Hungary

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Isehara-shi, 259-1193, Japan

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Kōtoku, 135-8550, Japan

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Kurume-shi, 830-0011, Japan

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Matsuyama, 791-0280, Japan

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Morioka, 028-3695, Japan

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Niigata, 951-8520, Japan

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Ota-shi, 373-8550, Japan

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Sapporo, 060-8638, Japan

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Shinjuku-ku, 160-8582, Japan

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Tokyo, 104-0045, Japan

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Suwon, 16499, South Korea

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Goyang-si, 10408, South Korea

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Seoul, 03080, South Korea

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Tainan City, 704, Taiwan

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Changhua, 500, Taiwan

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New Taipei City, 220, Taiwan

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Taipei, 10449, Taiwan

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Taichung, 40705, Taiwan

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Shreveport, Louisiana, 71103, United States

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Charlotte, North Carolina, 28204, United States

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Charlottesville, Virginia, 22908, United States

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Vienna, 1090, Austria

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Yibin, 610500, China

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Odense, 5000, Denmark

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Oulu, 90029, Finland

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Tampere, 33520, Finland

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Caen, 14076, France

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Chemnitz, 09116, Germany

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Nagoya, 464-8681, Japan

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Akashi-shi, 673-8558, Japan

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Hidaka-shi, 350-1298, Japan

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Kashiwa, 227-8577, Japan

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Kashiwa-shi, 277-8567, Japan

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Kobe, 650-0047, Japan

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Osaka, 541-8567, Japan

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Sunto-gun, 411-8777, Japan

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Stavanger, 4011, Norway

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Lodz, 93-338, Poland

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Poznan, 60-569, Poland

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El Palmar, 30120, Spain

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L'Hospitalet de Llobregat, 08908, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Palma de Mallorca, 07010, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Valencia, 46006, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Valencia, 46009, Spain

No email / No phone

Status: Not yet recruiting

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Zaragoza, 50009, Spain

No email / No phone

Status: Not yet recruiting

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Stockholm, 17164, Sweden

No email / No phone

Status: Not yet recruiting

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Uppsala, 751 85, Sweden

No email / No phone

Status: Not yet recruiting

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Linköping, 581 85, Sweden

No email / No phone

Status: Not yet recruiting

Research Site

Lund, 22185, Sweden

No email / No phone

Status: Not yet recruiting

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Zurich, 8091, Switzerland

No email / No phone

Status: Not yet recruiting

Research Site

Sankt Gallen, 9007, Switzerland

No email / No phone

Status: Not yet recruiting

Research Site

Liestal, CH- 4410, Switzerland

No email / No phone

Status: Not yet recruiting

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Bath, BA1 3NG, United Kingdom

No email / No phone

Status: Not yet recruiting

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Cambridge, CB2 0QQ, United Kingdom

No email / No phone

Status: Not yet recruiting

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Leeds, LS9 7TF, United Kingdom

No email / No phone

Status: Not yet recruiting

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London, EC1A 7BE, United Kingdom

No email / No phone

Status: Not yet recruiting

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Manchester, M20 4BX, United Kingdom

No email / No phone

Status: Not yet recruiting

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Northwood, HA6 2RN, United Kingdom

No email / No phone

Status: Not yet recruiting

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Taunton, TA1 5DA, United Kingdom

No email / No phone

Status: Not yet recruiting

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Little Rock, Arkansas, 72205, United States

No email / No phone

Status: Not yet recruiting

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Duarte, California, 91010, United States

No email / No phone

Status: Not yet recruiting

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San Francisco, California, 94143, United States

No email / No phone

Status: Not yet recruiting

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La Jolla, California, 92037, United States

No email / No phone

Status: Not yet recruiting

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Fort Myers, Florida, 33901, United States

No email / No phone

Status: Not yet recruiting

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West Palm Beach, Florida, 33401, United States

No email / No phone

Status: Not yet recruiting

Research Site

Tampa, Florida, 33612, United States

No email / No phone

Status: Not yet recruiting

Research Site

St. Petersburg, Florida, 33705, United States

No email / No phone

Status: Not yet recruiting

Research Site

Miami Beach, Florida, 33140, United States

No email / No phone

Status: Not yet recruiting

Research Site

Augusta, Georgia, 30912, United States

No email / No phone

Status: Not yet recruiting

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Evanston, Illinois, 60201, United States

No email / No phone

Status: Not yet recruiting

Research Site

Arlington Heights, Illinois, 60005, United States

No email / No phone

Status: Not yet recruiting

Research Site

Baltimore, Maryland, 21201, United States

No email / No phone

Status: Not yet recruiting

Research Site

Worcester, Massachusetts, 01655, United States

No email / No phone

Status: Not yet recruiting

Research Site

Boston, Massachusetts, 02111, 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

Minneapolis, Minnesota, 55455, 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

St Louis, Missouri, 63141, 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

New York, New York, 10065, United States

No email / No phone

Status: Not yet recruiting

Research Site

Cincinnati, Ohio, 45220, 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

Eugene, Oregon, 97401, United States

No email / No phone

Status: Not yet recruiting

Research Site

Pittsburgh, Pennsylvania, 15224, 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

Providence, Rhode Island, 02905, 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

San Antonio, Texas, 78240, United States

No email / No phone

Status: Not yet recruiting

Research Site

Fort Worth, Texas, 76104, United States

No email / No phone

Status: Not yet recruiting

Research Site

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Research Site

Austin, Texas, 78758, United States

No email / No phone

Status: Not yet recruiting

Research Site

Saint Johnsbury, Vermont, 05819, United States

No email / No phone

Status: Not yet recruiting

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Fairfax, Virginia, 22031, United States

No email / No phone

Status: Not yet recruiting

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Madison, Wisconsin, 53705, United States

No email / No phone

Status: Not yet recruiting

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Charleroi, 6060, Belgium

No email / No phone

Status: Withdrawn

Research Site

Halifax, Nova Scotia, B3H 2Y9, Canada

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

Amsterdam, 1066CX, Netherlands

No email / No phone

Status: Withdrawn

Research Site

Leiden, 2333 ZA, Netherlands

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

Frauenfeld, 8501, Switzerland

No email / No phone

Status: Withdrawn

Research Site

Tucson, Arizona, 85704, United States

No email / No phone

Status: Withdrawn

Research Site

Sylmar, California, 91342, United States

No email / No phone

Status: Withdrawn

Research Site

Palo Alto, California, 94304, United States

No email / No phone

Status: Withdrawn

Research Site

Honolulu, Hawaii, 96813, 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

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Rilvegostomig (AZD2936)

Overview

Mechanism of action

Efficacy

Safety

Key trials (selection)

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (244)

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