RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Mocertatug rezetecan for Neoplasms, Endometrial

This study wants to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of care and will help us better understand its impact on Health-Related Quality of Life of participants.

Official registry: https://clinicaltrials.gov/study/NCT07684599 · GlaxoSmithKline · enrollment listed as 610

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Mocertatug rezetecan, Dostarlimab, or Pembrolizumab. The registry lists allocation as randomized. This study wants to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care.

They plan to enroll about 610 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

Interventions: Mocertatug rezetecan, Dostarlimab, Pembrolizumab

Primary outcome (registry wording): Progression free survival (PFS) by BICR assessment

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
Is able to commence C1D1 of study treatment within 3 - 9 weeks of the final dose of first-line therapy
Is deemed suitable to continue with maintenance therapy with immune checkpoint inhibition (dostarlimab or pembrolizumab)
Has histologically confirmed endometrial carcinoma including but not limited to endometrioid, serous, clear cell and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted
Meets one of the following criteria:
Has newly diagnosed stage III disease \[2023 International Federation of Gynecology and Obstetrics (FIGO) staging\] with measurable residual disease \>1 cm after primary debulking surgery (incomplete cytoreduction)
Has newly diagnosed stage III disease (2023 FIGO staging) that is not suitable for primary debulking surgery with measurable disease
Has newly diagnosed stage IV disease (2023 FIGO staging) and any residual disease status (measurable or non-measurable) following debulking surgery. Participants not suitable for primary debulking surgery are also permitted

Who the registry excludes

Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer
Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas
Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis
Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1
Has received treatment with an investigational agent within 30 days prior to C1D1
Has received prior therapy with topoisomerase I inhibitors (e.g. irinotecan or topotecan) or Antibody-Drug Conjugate (ADC)with a topoisomerase I inhibitor warhead, B7-H4 targeted therapy, or immune checkpoint inhibitor
Has received treatment with inhibitors of P-glycoprotein (P-gp) or Breast cancer resistant protein (BCRP), or OATP1B1/1B3 transporterswithin 7 days prior to the date of C1D1. Inducers of P-gp should be discontinued for at least 14 days prior to the date of C1D1

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

12 listed

GSK Investigational Site — Toronto, Ontario, Canada (recruiting)
GSK Investigational Site — Montreal, Quebec, Canada (recruiting)
GSK Investigational Site — Fukuoka, Japan (recruiting)
GSK Investigational Site — Fukushima, Japan (recruiting)
GSK Investigational Site — Hokkaido, Japan (recruiting)
GSK Investigational Site — Ibaraki, Japan (recruiting)
GSK Investigational Site — Miyagi, Japan (recruiting)
GSK Investigational Site — Numakunai, Japan (recruiting)
GSK Investigational Site — Osaka, Japan (recruiting)
GSK Investigational Site — Saitama, Japan (recruiting)
GSK Investigational Site — Tokyo, Japan (recruiting)
GSK Investigational Site — Daegu, South Korea (recruiting)

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FAQ about this NCT record

Is NCT07684599 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07684599?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07684599?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary