The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active enrolling
United States, Argentina, Australia, Brazil, Canada, Chile, France, Israel, Italy, Korea, Republic of, Peru, Singapore, Spain, Taiwan, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Disitamab vedotin arm
disitamab vedotin + pembrolizumab
DRUG: disitamab vedotin
Given into the vein (IV; intravenous) every 2 weeksDRUG: pembrolizumab
400mg given by IV every 6 weeksACTIVE_COMPARATOR: Standard of care arm
gemcitabine + cisplatin OR carboplatin
DRUG: gemcitabine
1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycleDRUG: cisplatin
70 mg\^2 given by IV on day 1 of every 3-week cycleDRUG: carboplatin
Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycleProgression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
Approximately 3 years
Overall survival (OS)
The time from date of randomization to date of death due to any cause.
Approximately 5 years
Objective response rate (ORR) per RECIST v1.1 by BICR
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Approximately 3 years
ORR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR or PR according to RECIST v1.1.
Approximately 3 years
Duration of Response (DOR) per RECIST v1.1 by BICR
The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.
Approximately 3 years
DOR per RECIST v1.1 by investigator assessment
The time from first documented response of CR or PR (that is subsequently confirmed) to the first documented disease progression per RECIST v1.1, or to death due to any cause.
Approximately 3 years
Control Rate (DCR) per RECIST v1.1 by BICR
The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.
Approximately 3 years
DCR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR, PR, or stable disease according to RECIST v1.1.
Approximately 3 years
PFS per RECIST v1.1 by investigator assessment
The time from randomization to first documentation of disease progression per RECIST v1.1, or to death due to any cause.
Approximately 3 years
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Through 30 days after the last study treatment; approximately 2 years
Number of participants with laboratory abnormalities
Through 30 days after the last study treatment; approximately 2 years
Treatment discontinuation rate due to AEs
Approximately 2 years
Number of electrocardiogram (ECG) abnormalities
Through 30 days after the last study treatment; approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF)
Through 2 years after last study treatment; approximately 4 years
Change from baseline to Week 16 in European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTC QLQ-C30) Global Health Status (GHS)/QoL Score
The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.
Approximately 2 years
Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score
The time from the date of randomization to the date of first deterioration (change from baseline ≥10) in GHS/QoL score with no subsequent recovery. The EORTC QLQ-C30 is used to evaluate health-related quality of life, functioning, disease symptoms, and treatment-related side effects. Scores range from 0-100. For GHS/QoL and functional scales, higher scores represent higher QoL or functioning. For symptom scales, higher scores represent more symptoms/worse status.
Approximately 2 years
Time to pain progression
The time from the date of randomization to whichever of the following occurs earlier: * an increase in Numeric Rating Scale (NRS) for pain intensity of 2 points or more from baseline at 2 consecutive visits, * an increase in number of opioid or analgesic use from baseline, * or initiation of opioid or analgesic use. NRS for pain intensity asks participants to best describe their pain at its worst in the last 24 hours from 0 to 10. On the NRS, 0 means no pain and 10 means pain as bad as you can imagine.
Approximately 2 years
400
Sponsor: Seagen Inc.
Collaborator: RemeGen Co., Ltd., Merck Sharp & Dohme LLC
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT05911295
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