Health TrialsbyHealthPanel

Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer

ConditionUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery.

The researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of muscle invasive bladder cancer (previously known as transitional cell) carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra)

Clinical Stage T2-T4, N1-N3, M0 OR cT1, N2-N3, M0

Representative urothelial carcinoma FFPE tumor specimens (tumor blocks or 20 unstained slides). Patients with < 20 slides may be enrolled after discussion with the principal investigator.

Muscle invasive urothelial carcinoma of the bladder histologically confirmed at the enrolling institution from TURBT. (Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed provided the extent of disease is confirmed via imaging and/or EUA.)

Disqualifiers

Evidence of NYHA functional class III or IV heart disease

Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack

On-going cardiac dysrhythmias of NCI CTCAE Version 5.0 grade ≥ 2. However, stable atrial fibrillation controlled medically or with a device (i.e. pacemaker) or prior ablation is allowed

Pre-existing sensory grade ≥ 2 neuropathy

Trial design

Design model

Single group

Treatments tested in this trial

  • Enfortumab vedotin

    Drug

    Enfortumab vedotin will be administered at 1.25 mg/kg on day 1 and day 8 of each 21-day cycle, for up to 6 cycles.

  • Pembrolizumab

    Drug

    Pembrolizumab will be administered on day 1 of each cycle, every 21 days, for 6 cycles.

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: enfortumab vedotin in combination with pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathologic complete response rate (pCR Rate)

Defined as lack of muscle invasive carcinoma (\<pT2) and the absence of lymph node metastasis (N0) in the final cystectomy specimen. Pathologic complete response to perioperative treatment is defined as the absence of carcinoma (pT0) and the absence of lymph node metastases (N0). Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.

Time frame
2 years

Secondary outcomes

1

Event free survival (EFS)

Event-free survival will be measured from the initiation of treatment. Any of the following events will qualify as an event: * Primary progression of disease (from time of confirmatory scan) * Recurrence of disease post-operatively with metastatic or local pelvic recurrence after radical cystectomy. * Patients who do not proceed to cystectomy due to toxicity * The assessment of disease recurrence versus development of a second primary tumor will be left to the discretion of the treating physician. If the patient did not progress nor die, the patient will be censored on the date of last follow-up

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Memorial Sloan Kettering Cancer Center

Lead sponsor

Astellas Pharma US, Inc.

Collaborator

Seagen Inc.

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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