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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, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom
EXPERIMENTAL: Part A: Tisotumab Vedotin - Q3W Schedule
Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)EXPERIMENTAL: Part B: Tisotumab Vedotin - 3Q4W Schedule
Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)EXPERIMENTAL: Part C: Tisotumab Vedotin - 2Q4W Schedule
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)EXPERIMENTAL: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Tisotumab Vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle in participants with various solid tumors in 1L HNSCC or sqNSCLC
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)DRUG: pembrolizumab
200mg or 400mg given by IVDRUG: carboplatin
AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IVDRUG: cisplatin
100mg/m\^2 given by IVEXPERIMENTAL: Part E: Tisotumab Vedotin - 2Q4W Schedule
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)EXPERIMENTAL: Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Tisotumab Vedotin + pembrolizumab. Tisotumab Vedotin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)DRUG: pembrolizumab
200mg or 400mg given by IVEXPERIMENTAL: Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Tisotumab Vedotin + pembrolizumab + carboplatin. Tisotumab Vedotin and carboplatin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting
DRUG: tisotumab vedotin
Given into the vein (IV; intravenously)DRUG: pembrolizumab
200mg or 400mg given by IVDRUG: carboplatin
AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IVConfirmed Objective Response Rate (ORR) (Parts A, B, C, D, F, and G)
Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Up to approximately 3 years
Confirmed ORR per blinded independent central review (BICR) (Part E)
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR
Up to approximately 3 years
Incidence of Adverse Events (AEs)
Type, severity, and relatedness of adverse events. An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Up to approximately 3 years
Confirmed and Unconfirmed ORR
Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator
Up to approximately 3 years
Confirmed and Unconfirmed ORR per BICR (Part E)
Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by BICR
Up to approximately 3 years
Disease Control Rate (DCR)
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks
Up to approximately 3 years
DCR per BICR (Part E)
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks
Up to approximately 3 years
Duration of Response (DOR)
Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by the investigator
Up to approximately 3 years
DOR per BICR (Part E)
Time from the first documentation of objective response to the first documentation of PD or death due to any cause, whichever comes first, as assessed by BICR
Up to approximately 3 years
Time to Response (TTR)
Time from the start of study treatment to the first documentation of objective response, as assessed by investigator
Up to approximately 1 year
TTR per BICR (Part E)
Time from the start of study treatment to the first documentation of objective response, as assessed by BICR
Up to approximately 1 year
Progression-free survival (PFS)
Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by the investigator
Up to approximately 3 years
PFS per BICR (Part E)
Time from the start of study treatment to the first documentation of PD according to RECIST v1.1 or death due to any cause, whichever comes first, as assessed by BICR
Up to approximately 3 years
Overall Survival (OS)
Time from the start of study treatment to date of death due to any cause
Up to approximately 4 years
Cmax
Maximum observed plasma concentration
Through 30-37 days following the last dose; up to approximately 3 years
Ctrough
Observed plasma concentration at the end of the dosing interval
Through 30-37 days following the last dose; up to approximately 3 years
Incidence of anti-therapeutic antibodies (ATAs)
Through 30-37 days following the last dose; up to approximately 3 years
692
Sponsor: Seagen Inc.
Collaborator: Genmab, Merck Sharp & Dohme LLC
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: