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Study of EV for Recurrent Endometrial Carcinoma

ConditionEndometrial Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWilliam Bradley

About this trial

This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patient of age ≥18 years.

Endometrioid endometrial carcinoma

Serous endometrial carcinoma

Prior standard of care of surgical intervention, including hysterectomy.

Disqualifiers

Diagnosis of endometrial sarcoma (leiomyosarcoma, endometrial stromal sarcoma, high-grade sarcoma).

Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.

Tumor sample does not express nectin-4 (local IHC testing).

Symptomatic CNS metastases or leptomeningeal metastases. Patients with symptomatic brain metastasis must be treated and must be stable for at least 4 weeks prior to study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Enfortumab Vedotin

    Drug

    Enfortumab vedotin is an ADC comprised of a fully human IgG1Κ antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable linker. Enfortumab vedotin is thought to induce anti-tumor activity by binding to the nectin-4 protein on the surface of cancer cells, leading to internalization, proteolytic cleavage of the linker, and intracellular release of MMAE that subsequently disrupts tubulin polymerization and leads to mitotic arrest and apoptosis of the tumor cell.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycleExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Estimate the overall response rate (ORR)

Overall response rate (ORR) of enfortumab vedotin treatment for patients with endometrioid or serous endometrial cancer, i.e., proportion of patients with a complete or partial response as per RECIST v1.1.

Time frame
24 months
2

Evaluate the safety of enfortumab vedotin treatment

Incidence of adverse events (AEs) and serious adverse event (SAEs) as defined by NCI CTCAE v5.

Time frame
24 months

Secondary outcomes

1

Characterize the Duration of Response (DOR)

Duration of response (DOR), i.e., the time from date of initial response to therapy by RECIST v1.1 to subsequent disease progression, relapse or death.

Time frame
30 months
2

Estimate overall survival (OS)

Median overall survival (OS), i.e., the time from date of treatment to the date of death due to any reason.

Time frame
24 months
3

Estimate progression-free survival (PFS)

the time from date of treatment to the date of disease progression or death, as assessed per RECIST v1.1.

Time frame
12 months
4

Duration of response (DOR) by MMR status.

Subgroup analysis of response by MMR status (i.e., proficient or deficient), and by TCGA sub-type, 1. Ultramutated (POLE), 2. Hypermutated (MSI), 3. Copy Number low (endometrioid), 4. Copy-Number high (serous like).

Time frame
30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

William Bradley

Lead sponsor

Medical College of Wisconsin

Sponsor institution

Astellas Pharma Inc

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: