The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.
The master screening protocol is MK-3475-U06 (KEYMAKER-U06)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IV Infusion
Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid, administered per approved product label
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 14 months
Duration of Response (DOR)
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 18 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 18 months
Overall Survival (OS)
OS is defined as time from randomization to death due to any cause.
Time frame: Up to approximately 26 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UPMC Hillman Cancer Center ( Site 3904)
Pittsburgh, Pennsylvania, United States
RECRUITINGLiga Norte Riograndense Contra o Cancer ( Site 3301)
Natal, Rio Grande do Norte, Brazil
RECRUITINGHospital Nossa Senhora Da Conceicao ( Site 3300)
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGFALP ( Site 3400)
Santiago, Region M. de Santiago, Chile
RECRUITINGBradfordhill ( Site 3401)
Santiago, Region M. de Santiago, Chile
RECRUITINGAnhui Provincial Hospital ( Site 2506)
Hefei, Anhui, China
RECRUITINGBeijing Cancer Hospital ( Site 2500)
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated hospital of Xiamen University ( Site 2504)
Xiamen, Fujian, China
RECRUITINGHenan Cancer Hospital ( Site 2501)
Zhengzhou, Henan, China
RECRUITINGXuzhou Central Hospital ( Site 2502)
Xuzhou, Jiangsu, China
RECRUITING...and 22 more locations
Number of Participants Who Experience an Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 18 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 18 months