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A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03288545
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. 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. Some parts of the study will look at locally-advanced and metastatic urothelial cancer, which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Urinary Bladder Neoplasms Urologic Neoplasms Renal Pelvis Neoplasms Urothelial Cancer Ureteral Neoplasms Urethral Neoplasms Drug: enfortumab vedotin (EV) Drug: pembrolizumab Drug: cisplatin Drug: carboplatin Drug: gemcitabine Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Detailed Description:

This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts:

Locally advanced or metastatic urothelial cancer:

  • Dose escalation
  • Expansion

    • Part 1: Cohorts A and Optional B
    • Part 2: Cohorts D, E, and Optional F
    • Part 3: Cohort G.
  • Randomized Cohort K

    • EV Monotherapy Arm
    • EV Combination Arm

Muscle invasive bladder cancer:

  • Cohort H
  • Cohort J

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: multi-cohort, open-label, multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : March 2026

Arm Intervention/treatment
Experimental: EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda

Experimental: Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda

Experimental: Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda

Experimental: Cohort D: Enfortumab Vedotin + Cisplatin in 1L
Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: cisplatin
IV infusion on day 1 every 21 days

Experimental: Cohort E: Enfortumab Vedotin + Carboplatin in 1L
Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: carboplatin
IV infusion on day 1 every 21 days

Experimental: Optional Cohort F: Enfortumab Vedotin + Gemcitabine in 1L
Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: gemcitabine
IV infusion on days 1 and 8 every 21 days

Experimental: Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda

Drug: cisplatin
IV infusion on day 1 every 21 days

Drug: carboplatin
IV infusion on day 1 every 21 days

Experimental: Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
Enfortumab vedotin on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Experimental: Cohort J: EV + Pembrolizumab in MIBC neoadjuvant setting
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda

Experimental: Randomized Cohort K: Enfortumab Vedotin Monotherapy
Enfortumab vedotin on days 1 and 8 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Experimental: Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
  • ASG-22CE
  • ASG-22ME
  • PADCEV

Drug: pembrolizumab
IV infusion on day 1 every 21 days
Other Name: Keytruda




Primary Outcome Measures :
  1. Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated. ]
    Descriptive statistics will be used to summarize results.

  2. Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated. ]
    Descriptive statistics will be used to summarize results.

  3. Pathological complete response (pCR) rate per local pathology review (MIBC coohorts only) [ Time Frame: Up to approximately 5 months ]
    pCR rate is defined as the proportion of patients with pCR at the time of radical cystectomy (RC).

  4. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) [ Time Frame: Up to 3 years ]
    The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1


Secondary Outcome Measures :
  1. Incidence of dose-limiting toxicity (DLT) [ Time Frame: 21 days ]
    Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).

  2. Confirmed ORR by investigator assessment according to RECIST 1.1 (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Up to 3 years ]
    The proportion of patients with confirmed CR or PR according to RECIST 1.1.

  3. ORR by BICR according to RECIST 1.1 (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Up to 3 years ]
    The proportion of patients with confirmed CR or PR according to RECIST 1.1

  4. Confirmed ORR per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only) [ Time Frame: Up to 3 years ]
    The proportion of patients with confirmed CR or PR according to iRECIST.

  5. Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 5 years ]
    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.

  6. DCR by BICR according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 3 years ]
    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1

  7. DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only) [ Time Frame: Up to 3 years ]
    Proportion of patients with CR, PR, or SD according to iRECIST.

  8. Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 5 years ]
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD per RECIST 1.1) or to death due to any cause, whichever comes first.

  9. DOR by BICR according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 5 years ]
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per RECISTS 1.1 or to death due to any cause, whichever comes first

  10. DOR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only) [ Time Frame: Up to 5 years ]
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per iRECIST or to death due to any cause, whichever comes first.

  11. Progression free survival on study therapy (PFS1) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first.

  12. Progression free survival on study therapy (PFS1) by BICR according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first

  13. PFS1 by investigator assessment according to iRECIST (Dose expansion and Part 1-3 cohorts with pembrolizumab only) [ Time Frame: Up to 5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per iRECIST), or to death due to any cause, whichever comes first.

  14. Progression free survival (PFS) on study therapy by investigator assessment according to RECIST 1.1 (MIBC cohorts only) [ Time Frame: Up to 5 years ]
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first

  15. Overall survival (OS) (all cohorts) [ Time Frame: Up to 5 years ]
    The time from start of study treatment to date of death due to any cause.

  16. Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized (la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    Cmax will be derived from the PK blood samples collected.

  17. PK parameter for monomethyl auristatin E (MMAE): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    Cmax will be derived from the PK blood samples collected.

  18. PK parameter for enfortumab vedotin: Time to maximum concentration (Tmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    Tmax will be derived from the PK blood samples collected.

  19. PK parameter for MMAE: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    Tmax will be derived from the PK blood samples collected.

  20. PK parameter for enfortumab vedotin: Area under the concentration-time curve (AUC) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    AUC will be derived from the PK blood samples collected.

  21. PK parameter for MMAE: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 2 cycles of treatment, up to 42 days ]
    AUC will be derived from the PK blood samples collected.

  22. Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated. ]
    Blood samples for ATA analysis will be collected.

  23. pCR rate by central pathology review (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]
    Defined as the proportion of patients with pCR at the time of RC.

  24. PaR rate by local pathology review (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]
    The PaR rate is defined as the proportion of patients with pathologic downstaging to ≤ pT1pN0 at the time of RC.

  25. Pathological response (PaR) rate by central pathology review (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]
    The PaR rate is defined as the proportion of patients with pathologic downstaging to ≤ pT1pN0 at the time of RC.

  26. Disease-free survival (DFS) by investigator assessment according to RECIST 1.1 (MIBC cohorts only) [ Time Frame: Up to approximately 5 years ]
    DFS is defined as the time from RC to the time of first occurrence of a DFS event, including local recurrence of urothelial cancer (UC), urinary tract recurrence of UC, distant metastasis of UC, or death from any cause.

  27. Type, incidence, severity, seriousness, and relatedness of AEs (Randomized Cohort K and MIBC cohorts only) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years ]
    Descriptive statistics will be used to summarize results.

  28. Type, incidence, and severity of laboratory abnormalities (Randomized Cohort K and MIBC cohorts only) [ Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years ]
    Descriptive statistics will be used to summarize results.

  29. Percentage of planned surgeries delayed due to treatment-related AEs (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]
    Delayed is defined as greater than 12 weeks after the last dose of treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced or metastatic urothelial cancer (la/mUC) - Cohorts A, B, D, E, F, G and K

    • Histologically documented la/mUC, including squamous differentiation or mixed cell types.
    • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
    • Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure.
    • Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm).
    • 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.
    • Cohort K: Ineligible for cisplatin-based chemotherapy due to at least 1 of the following: Glomerular filtration rate (GFR) <60 mL/min and ≥30 mL/min, ECOG performance status of 2, NCI CTCAE Version 4.03 Grade ≥2 hearing loss, New York Heart Association (NYHA) Class III heart failure. No prior systemic treatment for locally advanced or metastatic disease. No adjuvant/neoadjuvant platinum-based therapy within 12 months prior to randomization.
  • Muscle Invasive Bladder Cancer (MIBC)- Cohorts H and J

    • Histologically confirmed muscle invasive bladder cancer at clinical stage cT2-T4a.
    • Medically fit (i.e. eligible for surgery) and scheduled for radical cystectomy.
    • ECOG performance status of 0, 1, or 2.
    • Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure.
    • Cohort H and J: Ineligible for cisplatin-based chemotherapy and no prior systemic treatment, chemoradiation, or radiation therapy for MIBC. May have received prior intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy for non-muscle invasive bladder cancer.
    • Cohort J: Eligible for pembrolizumab.

Exclusion Criteria:

  • la/mUC - Cohorts A, B, D, E, F, G, and K

    • 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.
  • MIBC - Cohorts H and J

    • Received prior systemic treatment, chemoradiation, and/or radiation therapy of muscle invasive bladder cancer.
    • Received any prior treatment with a CPI.
    • Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists.
    • Evidence of measurable nodal or metastatic disease.
    • Ongoing sensory or motor neuropathy Grade 2 or higher.
    • Conditions requiring high doses of steroids or other immunosuppressive medications.
    • Prior treatment with enfortumab vedotin or other MMAE-based ADCs for urothelial cancer.
    • History of another malignancy within 3 years before first dose of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288545


Contacts
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Seattle Genetics, Inc.
Investigators
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Study Director: Anne-Sophie Carret, MD Seattle Genetics, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03288545    
Other Study ID Numbers: SGN22E-002
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
ASG-22ME
ASG-22CE
Antibody-drug conjugate
Antineoplastic agents
CPI
Enfortumab vedotin
MIBC
Locally advanced urothelial cancer
Cisplatin
Drug therapy
Carboplatin
Metastatic urothelial cancer
Nectin-4
Gemcitabine
Muscle invasive bladder cancer
Checkpoint Inhibitors
Pembrolizumab
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Ureteral Neoplasms
Urethral Neoplasms
Pelvic Neoplasms
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ureteral Diseases
Urethral Diseases
Gemcitabine
Carboplatin
Pembrolizumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological