Trial · NCT06989112
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
NCT06989112, Phase 3, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06989112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06989112
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT06989112
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 600 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Endometrial Cancer
- Interventions
- Trastuzumab deruxtecan, Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel, Docetaxel
- First posted
- 2025-05-25
- Last updated
- 2026-10-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS), as assessed by BICR | Until progression or death due to any cause (assessed up to approximately 45 months). | Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause. |
| Secondary | Overall Survival (OS) | Until the date of death due to any cause (assessed up to approximately 70 months). | Defined as the time from randomization until the date of death due to any cause. |
| Secondary | Progression Free Survival (PFS) as assessed by the investigator | Until progression or death due to any cause (assessed up to approximately 70 months). | PFS by investigator has the same attributes as estimand of PFS by BICR except tumor assessment is by the investigator. |
| Secondary | Time from randomization to second progression or death (PFS2) | Until the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death (assessed up to approximately 70 months). | PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death. |
| Secondary | Objective response rate (ORR), as assessed by BICR and investigator | Until progression or the starting of subsequent anticancer therapy (assessed up to approximately 45 months). | ORR as assessed and confirmed by BICR is defined as the proportion of participants who have a complete response (CR) or partial response (PR), as determined and confirmed by BICR. ORR as assessed and confirmed by the investigator has the same attributes as estimand of ORR by BICR except tumor assessment per the investigator. |
| Secondary | Duration of response (DoR), as assessed by BICR and investigator | Until progression or death due to any cause (assessed up to approximately 45 months). | DoR as assessed by BICR will be defined as the time from the date of first documented response of confirmed responders until date of documented progression per RECIST 1.1, or death due to any cause. DoR as assessed by the investigator has the same attributes as estimand of DoR by BICR except tumor assessment per the investigator. |
| Secondary | Safety and tolerability | Safety is assessed until the 90 days (+7) after the last dose (assessed up to approximately 70 months). | Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), AESI, vital signs, clinical safety laboratory assessments, ECG and ECHO/MUGA scan results. |
| Secondary | Pharmacokinetics of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig | Up to safety follow-up period (assessed up to approximately 45 months). | Serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig. |
| Secondary | Immunogenicity of T- DXd and rilvegostomig | Up to safety follow-up period (assessed up to approximately 45 months). | Presence of ADAs for T-DXd or rilvegostomig. |
| Secondary | Patient-reported tolerability | Until progression as assessed by BICR (assessed up to approximately 45 months). | Patient-reported tolerability will be described among participants, as treated, using the following outcomes: * Symptomatic AEs: Descriptive summary of the proportion of participants reporting symptomatic AEs while on treatment, as assessed by items from the EORTC Item Library and the FACT/GOG-NTX-4 * Overall side-effect bother: Descriptive summary of the proportion of participants reporting overall side-effect bother on the PGI-TT while on treatment |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06989112
GET https://conductscience.org/api/trials/v1/NCT06989112/registered