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JOURNAL ONKOLOGIE – STUDIE
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Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

Rekrutierend

NCT-Nummer:
NCT03485209

Studienbeginn:
Juni 2018

Letztes Update:
06.08.2024

Wirkstoff:
Tisotumab vedotin, Pembrolizumab, Carboplatin, Cisplatin

Indikation (Clinical Trials):
Carcinoma, Pancreatic Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Seagen Inc.

Collaborator:
Genmab, Merck Sharp & Dohme LLC,

Studienleiter

Medical Monitor
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 71)

Ruhr-Uni. Bochum, St. Josef-Hospital
44791 Bochum
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Universitätsklinikum Halle-Universitätsklinik und Poliklinik
06120 Halle
(Sachsen-Anhalt)
GermanyAbgeschlossen» Google-Maps
Vincentius-Diakonissen-Kliniken gAG
76137 Karlsruhe
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University of California Davis
95817 Sacramento
United StatesAbgeschlossen» Google-Maps
Stanford Cancer Center / Blood and Marrow Transplant Program
95124 San Jose
United StatesAbgeschlossen» Google-Maps
University Cancer & Blood Center, LLC
30607 Athens
United StatesAbgeschlossen» Google-Maps
Winship Cancer Institute / Emory University School of Medicine
30322 Atlanta
United StatesAbgeschlossen» Google-Maps
University of Chicago Medical Center
60637 Chicago
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ari Rosenberg, MD
Phone: 773-702-8222
E-Mail: arirosenberg@medicine.bsd.uchicago.edu» Ansprechpartner anzeigen
Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center
60115 DeKalb
United StatesRekrutierend» Google-Maps
Northwestern Medicine Cancer Center Delnor
60134 Geneva
United StatesRekrutierend» Google-Maps
Ingalls Cancer Care / Ingalls Memorial Hospital
60426 Harvey
United StatesAbgeschlossen» Google-Maps
Northwestern Medicine Cancer Center Warrenville
60555 Warrenville
United StatesRekrutierend» Google-Maps
University of Kansas Cancer Center
66205 Fairway
United StatesAbgeschlossen» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesAbgeschlossen» Google-Maps
HealthPartners Institute
55426 Saint Louis Park
United StatesAbgeschlossen» Google-Maps
Weill Cornell Medicine
10065 New York
United StatesAbgeschlossen» Google-Maps
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
27599 Chapel Hill
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Doris Caldwell
Phone: 919-379-8300
E-Mail: doris_caldwell@med.unc.edu» Ansprechpartner anzeigen
Wake Forest Baptist Medical Center / Wake Forest University
27157 Winston-Salem
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Deonna Asbury
Phone: 336-713-7035
E-Mail: dasbury@wakehealth.edu» Ansprechpartner anzeigen
University of Pennsylvania / Perelman Center for Advanced Medicine
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Lova Sun
Phone: 267-847-9623
E-Mail: Lova.sun@pennmedicine.upenn.edu» Ansprechpartner anzeigen
Texas Oncology - Fort Worth
75246 Dallas
United StatesAbgeschlossen» Google-Maps
MD Anderson Cancer Center / University of Texas
77030-4095 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Guermarie Velazquez-Torres
Phone: 713-745-4367
E-Mail: gvtorres@mdanderson.org» Ansprechpartner anzeigen
Renovatio Clinical
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
University of Virginia
22903 Charlottesville
United StatesAbgeschlossen» Google-Maps
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
98109 Seattle
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Cristina P Rodriguez
Phone: 206-288-7222
E-Mail: rodrigcr@uw.edu» Ansprechpartner anzeigen
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-Maps
APHM Hôpital Nord
13915 Marseille Cedex 20
FranceRekrutierend» Google-Maps
Hopital Prive du Confluent
44277 Nantes Cedex 2
FranceRekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Azienda Ospedaliera Spedali Civili di Brescia
25123 Brescia
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria (AOU) Master Domin U.O. Oncologia Medica Traslazzionale
88100 Catanzaro
ItalyRekrutierend» Google-Maps
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
47014 Meldola FC
ItalyRekrutierend» Google-Maps
Seconda Università degli Studi di Napoli, AOU
80131 Napoli
ItalyRekrutierend» Google-Maps
Oncologia Medica, Ospedale Civile S. Maria delle Croci
48121 Ravenna
ItalyRekrutierend» Google-Maps
Pan American Center for Oncology Trials, LLC
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Quironsalud Barcelona Instituto Oncologico Baselga
08023 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos
28034 Madrid
SpainRekrutierend» Google-Maps
HM Centro Integral Oncologico Clara Campal
28050 Madrid
SpainAbgeschlossen» Google-Maps
Althaia Xarxa Assistencial Manresa
08243 Manresa
SpainRekrutierend» Google-Maps
Son LLatzer University Hospital
07198 Palma de Mallorca
SpainRekrutierend» Google-Maps
Guys and St Thomas Hospital
SE1 9RT London
United KingdomAbgeschlossen» Google-Maps
The Royal Marsden Hospital Chelsea
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust (RM)
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The primary goal of this trial is to assess the activity, safety, and tolerability of

tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated

with single agent tisotumab vedotin or tisotumab vedotin in combination with other

anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts

based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous

non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and

neck squamous cell carcinoma (HNSCC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Parts A, B, and C

- Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer,

sqNSCLC, or HNSCC participants who are not candidates for standard therapy.

- All participants must have experienced disease progression on or after their

most recent systemic therapy.

- Colorectal cancer (closed to enrollment): participants must have received prior

therapy with each of following agents, if eligible: a fluoropyrimidine,

oxaliplatin, irinotecan, and/or bevacizumab. Participants should have received

no more than 3 systemic regimens in the metastatic setting.

- sqNSCLC (closed to enrollment): Participants with NSCLC must have predominant

squamous histology. Participants must have received prior therapy with a

platinum-based treatment and a checkpoint inhibitor (CPI), if eligible.

Participants should have received no more than 3 lines of systemic therapy in

the metastatic setting.

- Participants eligible for a tyrosine kinase inhibitor should have received

such therapy. These participants should have received no more than 4 lines

of systemic therapy in the metastatic setting.

- Exocrine pancreatic adenocarcinoma (closed to enrollment): Participants with

exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma

histology. Participants must have received prior therapy with a

gemcitabine-based or 5FU-based regimen, if eligible, and should have received

no more than 1 systemic regimen in the unresectable or metastatic setting.

- HNSCC (closed to enrollment): Participants with HNSCC in Part C must have

received prior therapy with a platinum-based regimen and/or a checkpoint

inhibitor (CPI), if eligible, and must have experienced disease progression

following such therapy. Participants should have received no more than 3

systemic lines of therapy in the recurrent or metastatic setting.

- Part E

- Participants with HNSCC must have experienced disease progression on or after

their most recent systemic therapy. Participants should have received no more

than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as

specified below. Participants must have received a platinum-based regimen and a

PD-(L)1 inhibitor.

- Parts D, F, and G

- Part D is closed to enrollment. Part F and Part G will enroll only participants

with HNSCC.

- Participants with HNSCC must have received no previous systemic therapy in the

recurrent or metastatic disease setting.

- Part D only

- Participants with NSCLC must have histologically or cytologically

documented squamous cell NSCLC and must have received no previous systemic

therapy for metastatic disease or radiation therapy to the lung that is >

30 Gy within 6 months of the first dose of study treatment.

- PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be

available

- Part F only

- Participants must have CPS ≥1 by local PD-L1 IHC assay to be eligible for

enrollment. Participants must be able to submit a tissue sample for

retrospective PD-L1 testing. Tissue may be fresh biopsy or archival,

collected within 2 years of Cycle 1 Day 1.

- Part G only

- Non-EU eligibility criteria: No CPS requirement for the cohort evaluating

tisotumab vedotin in combination with pembrolizumab and carboplatin.

- EU-specific eligibility criteria: Participants must have a CPS ≥1 by local

PD-L1 IHC assay.

- Participants must be able to submit a tissue sample for retrospective

PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2

years of Cycle 1 Day 1.

- Baseline measurable disease as measured by RECIST v1. 1.

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

- Participants with primary neuroendocrine or sarcomatoid histologies. For HNSCC,

participants may not have a primary site of nasopharynx or salivary gland.

- Active bleeding conditions

- Ocular surface disease at the time of enrollment (Note: cataract is not considered

active ocular surface disease for this protocol)

- Other cancer: known past or current malignancy other than inclusion diagnosis.

- Uncontrolled tumor-related pain

- Inflammatory lung disease. Participants with pulmonary disease are allowed if

systemic steroids and long-term oxygen are not required

- Peripheral neuropathy greater than or equal to Grade 2

- Active brain metastasis

- Ongoing clinically significant toxicity associated with prior treatment (including

radiotherapy or surgery).

- Part D, F, and G Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2

agent or with an agent directed to another stimulatory or co-inhibitory T-cell

receptor.

Studien-Rationale

Primary outcome:

1. Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, F, and G) (Time Frame - Up to approximately 3 years):
Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

2. Confirmed ORR per blinded independent central review (BICR) (Part E) (Time Frame - Up to approximately 3 years):
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by BICR

Secondary outcome:

1. Incidence of Adverse Events (AEs) (Time Frame - Up to approximately 3 years):
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.

2. Confirmed and Unconfirmed ORR (Time Frame - Up to approximately 3 years):
Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

3. Confirmed and Unconfirmed ORR per BICR (Part E) (Time Frame - Up to approximately 3 years):
Proportion of patients who achieve a CR or PR according to RECIST v1.1 as assessed by BICR

4. Disease Control Rate (DCR) (Time Frame - Up to approximately 3 years):
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

5. DCR per BICR (Part E) (Time Frame - Up to approximately 3 years):
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

6. Duration of Response (DOR) (Time Frame - Up to approximately 3 years):
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

7. DOR per BICR (Part E) (Time Frame - Up to approximately 3 years):
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

8. Time to Response (TTR) (Time Frame - Up to approximately 1 year):
Time from the start of study treatment to the first documentation of objective response, as assessed by investigator

9. TTR per BICR (Part E) (Time Frame - Up to approximately 1 year):
Time from the start of study treatment to the first documentation of objective response, as assessed by BICR

10. Progression-free survival (PFS) (Time Frame - Up to approximately 3 years):
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

11. PFS per BICR (Part E) (Time Frame - Up to approximately 3 years):
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

12. Overall Survival (OS) (Time Frame - Up to approximately 4 years):
Time from the start of study treatment to date of death due to any cause

13. Cmax (Time Frame - Through 30-37 days following the last dose; up to approximately 3 years):
Maximum observed plasma concentration

14. Ctrough (Time Frame - Through 30-37 days following the last dose; up to approximately 3 years):
Observed plasma concentration at the end of the dosing interval

15. Incidence of anti-therapeutic antibodies (ATAs) (Time Frame - Through 30-37 days following the last dose; up to approximately 3 years)

Studien-Arme

  • 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+
  • 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+
  • 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+
  • 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
  • Experimental: 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
  • 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
  • Experimental: 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

Geprüfte Regime

  • tisotumab vedotin (TIVDAK):
    Given into the vein (IV; intravenously)
  • pembrolizumab (KEYTRUDA®):
    200mg or 400mg given by IV
  • carboplatin:
    AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
  • cisplatin:
    100mg/m^2 given by IV

Quelle: ClinicalTrials.gov


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