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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03288545 |
|
Recruitment Status :
Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : October 18, 2023
|
Sponsor:
Astellas Pharma Global Development, Inc.
Collaborators:
Merck Sharp & Dohme LLC
Seagen Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| 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 ...
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 348 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | multi-cohort, open-label, multicenter study, global |
| 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 : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2026 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Enfortumab vedotin
| 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:
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:
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:
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:
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:
Drug: carboplatin IV infusion on day 1 every 21 days |
|
Experimental: Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
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:
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:
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:
|
|
Experimental: Optional 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:
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:
|
|
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:
Drug: pembrolizumab IV infusion on day 1 every 21 days
Other Name: Keytruda |
|
Experimental: Cohort L: Enfortumab vedotin in MIBC in perioperative setting
Enfortumab vedotin on days 1 and 8 and every 21 days
|
Drug: enfortumab vedotin (EV)
Intravenous (IV) infusion on days 1 and 8 every 21 days
Other Names:
|
Primary Outcome Measures :
- 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. ]Descriptive statistics will be used to summarize results.
- 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. ]Descriptive statistics will be used to summarize results.
- 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 ]The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1
- Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.
Secondary Outcome Measures :
- 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).
- Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) [ Time Frame: Up to 3 years ]The proportion of patients with confirmed CR or PR according to RECIST 1.1.
- Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only) [ Time Frame: Up to 3 years ]The proportion of patients with confirmed CR or PR according to RECIST 1.1
- 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 ]The proportion of patients with confirmed CR or PR according to iRECIST.
- 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.
- DCR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only) [ Time Frame: Up to 3 years ]Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1
- 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.
- 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.
- DOR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K 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 RECIST 1.1 or to death due to any cause, whichever comes first
- 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.
- 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 ]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.
- PFS by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K 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) on or following study therapy, or to death due to any cause, whichever comes first
- PFS 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 start of study treatment to first documentation of objective tumor progression (PD per iRECIST) on or following study therapy, or to death due to any cause, whichever comes first.
- Event-free (EFS) on study therapy by BICR (Cohort L only) [ Time Frame: Up to 3 years ]The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.
- Event-free (EFS) on study therapy by investigator assessment (MIBC cohorts only) [ Time Frame: Up to 3 years ]The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.
- 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.
- 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.
- 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.
- PK parameter for total antibody (Tab): 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.
- 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.
- 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.
- 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.
- PK parameter for Tab: 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.
- 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.
- 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.
- PK parameter for Tab: 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.
- Pathologic downstaging (pDS) rate by central pathology review (MIBC cohorts only) [ Time Frame: Up to approximately 5 months ]The pDS rate is defined as patients with tumors <pT2 and N0 in examined tissue from radical cystectomy (RC) and pelvic lymph node dissection (PLND).
- Disease-free survival (DFS) by investigator assessment (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.
- DFS by BICR (Cohort L only) [ Time Frame: Up to 3 years ]DFS is defined as the time from RC to the time of first occurrence of a DFS event
- 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.
- 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.
- Percentage of planned radical cystectomy and pelvic lymph node dissections (RC+PLND) 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.
| 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, 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.
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
Locations
Show 106 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Merck Sharp & Dohme LLC
Seagen Inc.
Investigators
| Study Director: | Changting Meng, MD | Seagen Inc. | |
| Study Director: | Jason Lukas, MD, PhD | Seagen Inc. |
| Responsible Party: | Astellas Pharma Global Development, Inc. |
| ClinicalTrials.gov Identifier: | NCT03288545 |
| Other Study ID Numbers: |
SGN22E-002 MK-3475-869 ( Other Identifier: Merck ) KEYNOTE KN-869 ( Other Identifier: Merck ) |
| First Posted: | September 20, 2017 Key Record Dates |
| Last Update Posted: | October 18, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| 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 PD-1 inhibitor |
Additional relevant MeSH terms:
|
Neoplasms Urinary Bladder Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Ureteral Neoplasms Urethral Neoplasms Pelvic Neoplasms Urogenital Neoplasms Neoplasms by Site Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Ureteral Diseases Urethral Diseases Carboplatin Gemcitabine Pembrolizumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |