Trial Search Results

A Study of Enfortumab Vedotin Plus Pembrolizumab and/or Chemotherapy for Patients With Urothelial Bladder Cancer (EV-103)

This study will test an experimental drug (enfortumab vedotin) with different combinations of pembrolizumab and/or chemotherapy. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This study will have different parts to look at the side effects of (1) enfortumab vedotin with pembrolizumab, (2) enfortumab vedotin with chemotherapy, and (3) enfortumab vedotin with pembrolizumab and chemotherapy. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Collaborator: Seattle Genetics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: enfortumab vedotin
  • Drug: pembrolizumab
  • Drug: cisplatin
  • Drug: carboplatin
  • Drug: gemcitabine

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Histologically documented locally advanced or metastatic urothelial carcinoma
   (la/mUC), including squamous differentiation or mixed cell types.

   - An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.

   - Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, and G)

   - Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no
   prior treatment for la/mUC, or have disease progression following at least 1
   platinum-containing treatment.

   - Cohort A: Ineligible for cisplatin-based chemotherapy and no prior treatment for
   la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.

   - Cohort B: Must have disease progression during/following treatment with at least 1
   platinum-containing regimen for la/mUC or disease recurrence.

   - Cohort D: Eligible for cisplatin-based chemotherapy and no prior treatment for la/mUC.
   No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.

   - Cohort E: Ineligible for cisplatin-based chemotherapy, eligible for carboplatin, and
   no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in
   at least 12 months.

   - Cohort F: Ineligible for platinum-based chemotherapy, or disease progression
   during/following at least 1 prior treatment for la/mUC. Eligible for gemcitabine.

   - Cohort G: Eligible for platinum-based chemotherapy (either cisplatin or carboplatin)
   and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based
   therapy in at least 12 months.

Exclusion Criteria:

   - Received any prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2
   inhibitor, except Cohort F.

   - Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents,
   such as CD137 agonists, OX-40 agonists, or cytotoxic T-lymphocyte-associated protein 4
   (CTLA-4) inhibitors (except Cohort F).

   - Ongoing sensory or motor neuropathy Grade 2 or higher.

   - Active central nervous system (CNS) metastases.

   - Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior
   treatment (including radiotherapy or surgery).

   - Conditions requiring high doses of steroids or other immunosuppressive medications

   - Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based
   antibody-drug conjugates (ADCs).

   - Uncontrolled diabetes mellitus

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shermeen Poushnejad
650-724-7662
Recruiting