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NCT03288545 · CITED IN SOURCE DOCUMENTS

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2026-03-24

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 or metastatic urothelial cancer (la/mUC), 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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, J and L. * Histologically confirmed MIBC with predominant \>50% urothelial histology: Cohorts H and J: Clinical stage cT2-T4aN0M0; Cohort L: Clinical stage cT2-T4aN0M0 or cT1-T4aN1M0: Participants with pT1 disease are eligible only if they have N1 disease on imaging. Mixed cell types are eligible if urothelial cancer is predominant (\>50%); Participants with plasmacytoid and/or neuroendocrine tumors are ineligible regardless of component percentage. Urothelial tumors not originating in the bladder (eg, upper tract tumors, urethral tumors) are ineligible. * Must be cisplatin-ineligible. * Cohort-specific eligibility: Cohort J, H, and L: No prior systemic treatment, chemoradiation, or radiation therapy for MIBC. May have received prior intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy for non-MIBC; Cohort J: Eligible for pembrolizumab. * ECOG performance status of 0, 1, or 2. * Anticipated life expectancy of ≥3 months. * Tumor samples with an associated pathology report from the diagnostic transurethral resection of a bladder tumor done 90 days prior to the first dose of study treatment must be available prior to enrollment and determined to be sufficient for pathology review and biomarker analysis. * Participants must be deemed eligible for RC+PLND. 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, J, and L * 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. * For participants in Cohort H, evidence of nodal disease on imaging. For participants in Cohort L, ≥N2 nodal disease on imaging. * Participant has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC. * 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. * Participants with a history of another invasive malignancy within 3 years before first dose of study drug.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    label
    EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
    type
    EXPERIMENTAL
  2. description
    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    label
    Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
    type
    EXPERIMENTAL
  3. description
    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    label
    Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
    type
    EXPERIMENTAL
  4. description
    Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: cisplatin
    label
    Cohort D: Enfortumab Vedotin + Cisplatin in 1L
    type
    EXPERIMENTAL
  5. description
    Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: carboplatin
    label
    Cohort E: Enfortumab Vedotin + Carboplatin in 1L
    type
    EXPERIMENTAL
  6. description
    Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: gemcitabine
    label
    Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
    type
    EXPERIMENTAL
  7. description
    Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    3. Drug: cisplatin
    4. Drug: carboplatin
    label
    Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
    type
    EXPERIMENTAL
  8. description
    Enfortumab vedotin on days 1 and 8 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    label
    Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
    type
    EXPERIMENTAL
  9. description
    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    label
    Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
    type
    EXPERIMENTAL
  10. description
    Enfortumab vedotin on days 1 and 8 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    label
    Randomized Cohort K: Enfortumab Vedotin Monotherapy
    type
    EXPERIMENTAL
  11. description
    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    2. Drug: pembrolizumab
    label
    Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
    type
    EXPERIMENTAL
  12. description
    Enfortumab vedotin on days 1 and 8 and every 21 days
    intervention Names
    1. Drug: enfortumab vedotin (EV)
    label
    Cohort L: Enfortumab vedotin in MIBC in perioperative setting
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
    2. Cohort D: Enfortumab Vedotin + Cisplatin in 1L
    3. Cohort E: Enfortumab Vedotin + Carboplatin in 1L
    4. Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
    5. Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
    6. Cohort L: Enfortumab vedotin in MIBC in perioperative setting
    7. EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
    8. Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
    9. Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
    10. Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
    11. Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
    12. Randomized Cohort K: Enfortumab Vedotin Monotherapy
    description
    Intravenous (IV) infusion on days 1 and 8 every 21 days
    name
    enfortumab vedotin (EV)
    other Names
    1. ASG-22CE
    2. ASG-22ME
    3. PADCEV
    type
    DRUG
  2. arm Group Labels
    1. Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
    2. Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
    3. EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
    4. Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
    5. Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
    6. Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
    description
    IV infusion on day 1 every 21 days
    name
    pembrolizumab
    other Names
    1. Keytruda
    type
    DRUG
  3. arm Group Labels
    1. Cohort D: Enfortumab Vedotin + Cisplatin in 1L
    2. Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
    description
    IV infusion on day 1 every 21 days
    name
    cisplatin
    type
    DRUG
  4. arm Group Labels
    1. Cohort E: Enfortumab Vedotin + Carboplatin in 1L
    2. Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
    description
    IV infusion on day 1 every 21 days
    name
    carboplatin
    type
    DRUG
  5. arm Group Labels
    1. Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
    description
    IV infusion on days 1 and 8 every 21 days
    name
    gemcitabine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
multi-cohort, open-label, multicenter study, global
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
348
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Descriptive statistics will be used to summarize results.
    measure
    Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)
    time Frame
    Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
  2. description
    Descriptive statistics will be used to summarize results.
    measure
    Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
    time Frame
    Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.
  3. description
    The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1
    measure
    Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
    time Frame
    Up to 3 years
  4. description
    The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.
    measure
    Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
    time Frame
    Up to approximately 5 months
secondary Outcomes
  1. description
    Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).
    measure
    Incidence of dose-limiting toxicity (DLT)
    time Frame
    21 days
  2. description
    The proportion of patients with confirmed CR or PR according to RECIST 1.1.
    measure
    Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
    time Frame
    Up to 3 years
  3. description
    The proportion of patients with confirmed CR or PR according to RECIST 1.1
    measure
    Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)
    time Frame
    Up to 3 years
  4. description
    The proportion of patients with confirmed CR or PR according to iRECIST.
    measure
    Confirmed ORR by investigator assessment 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
  5. description
    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.
    measure
    Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
    time Frame
    Up to 5 years
  6. description
    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1
    measure
    DCR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
    time Frame
    Up to 3 years
  7. description
    Proportion of patients with CR, PR, or SD according to iRECIST.
    measure
    DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only)
    time Frame
    Up to 3 years
  8. description
    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.
    measure
    Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
    time Frame
    Up to 5 years
  9. description
    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per RECIST 1.1 or to death due to any cause, whichever comes first
    measure
    DOR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
    time Frame
    Up to 5 years
  10. description
    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.
    measure
    DOR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
    time Frame
    Up to 5 years
  11. description
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first.
    measure
    Progression free survival on study therapy (PFS) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
    time Frame
    Up to 5 years
  12. description
    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first
    measure
    PFS by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
    time Frame
    Up to 5 years
Full study description
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 or metastatic urothelial cancer (la/mUC), 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.
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 * Optional Cohort J * Cohort L
Source references
references
  1. citation
    Milowsky MI, O'Donnell PH, Hoimes CJ, Petrylak DP, Flaig TW, Moon HH, Friedlander TW, Mar N, McKay RR, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret AS, Yu Y, Dillon R, Kataria R, Beaumont JL, Purnajo I, Rosenberg JE. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12.
    pmid
    38215355
    type
    DERIVED
  2. citation
    O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, Moon HH, Friedlander TW, McKay RR, Bilen MA, Srinivas S, Burgess EF, Ramamurthy C, George S, Geynisman DM, Bracarda S, Borchiellini D, Geoffrois L, Maroto Rey JP, Ferrario C, Carret AS, Yu Y, Guseva M, Homet Moreno B, Rosenberg JE. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2023 Sep 1;41(25):4107-4117. doi: 10.1200/JCO.22.02887. Epub 2023 Jun 27.
    pmid
    37369081
    type
    DERIVED
  3. citation
    Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.
    pmid
    36041086
    type
    DERIVED
Source notices and limitations
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      requested nct id
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      primary nct id
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      source kind
      fda_spl_label
      source url
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761137
      clinical indication matching status
      not_inferred
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      true
      id
      nct-edge-7e5221665aa7e3e6c083
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        h Previously Untreated LA/mUC Who Are Cisplatin-Ineligible EV-103 The efficacy of PADCEV in combination with intravenous pembrolizumab was evaluated in EV-103 (NCT03288545), an open-label, multi-cohort (dose escalation cohort, Cohort A, Cohort K) trial in patients with locally advanced or metastatic urothelial cancer who were ine
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        exact text
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      source file sha256
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      source json pointer
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      source kind
      fda_spl_label
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      source string basis
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      source string sha256
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      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=700&sort=id%3Aasc
      spl effective time
      20260804
      spl set id
      b5631d3e-4604-4363-8f20-11dfc5a4a8ed
    3. release id
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      edge id
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      requested nct id
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      primary nct id
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      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source record id
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      source file sha256
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      payload sha256
      ce0edd66b354c8df93990f926e2d0531e19aea7aa84e375eba39965a99d1e02c
      payload
      application numbers
      1. BLA125514
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-bea3586a68034f8e1725
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        Patients who are Cisplatin-Ineligible with Urothelial Cancer The efficacy of KEYTRUDA in combination with enfortumab vedotin-ejfv was evaluated in KEYNOTE-869 (NCT03288545), an open-label, multi-cohort (dose escalation cohort, Cohort A, Cohort K) study in patients with locally advanced or metastatic urothelial cancer who were ine
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        exact text
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      offset unit
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      source file
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      source file sha256
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      source json pointer
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      source kind
      fda_spl_label
      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      spl effective time
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      9333c79b-d487-4538-a9f0-71b91a02b287
    4. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
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      requested nct id
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      primary nct id
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      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=0&sort=id%3Aasc
      source record id
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761467
      clinical indication matching status
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      link basis
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      nct id
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      occurrences
      1. context exact
        Cisplatin-Ineligible with Urothelial Cancer The efficacy of intravenous pembrolizumab in combination with enfortumab vedotin-ejfv was evaluated in KEYNOTE-869 (NCT03288545), an open-label, multi-cohort (dose escalation cohort, Cohort A, Cohort K) study in patients with locally advanced or metastatic urothelial cancer who were ine
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        exact text
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      source file sha256
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      source json pointer
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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      source url
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      spl effective time
      20260731
      spl set id
      097d166f-b73b-41d3-9b37-7653cd2a0c41

    Preserved source evidence · Not medical advice