Informations générales (source: ClinicalTrials.gov)
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors (innovaTV 207)
Interventional
Phase 2
Seagen, a wholly owned subsidiary of Pfizer (Voir sur ClinicalTrials)
juin 2018
août 2026
26 avril 2025
This trial will study tisotumab vedotin to find out whether it is an effective treatment
alone or with other anticancer drugs for certain solid tumors and what side effects
(unwanted effects) may occur. There are seven parts to this study.
- In Part A, the treatment will be given to participants every 3 weeks (3-week
cycles).
- In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every
4-week cycle.
- In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every
4-week cycle.
- In Part D, participants will be given treatment on Day 1 of every 3-week cycle.
Participants in Part D will get tisotumab vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin
- In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every
4-week cycle.
- In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of
every 6-week cycle. Participants in Part F will get tisotumab vedotin with
pembrolizumab.
- In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of
every 6-week cycle. Participants in Part G will get tisotumab vedotin with
pembrolizumab and carboplatin.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 11/06/2024 12:55:45 | Contacter | ||
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:11:59 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM Hôpital Nord - 13915 - Marseille Cedex 20 - Other - France | Contact (sur clinicalTrials) | ||||
| Centre léon Bérard - 69008 - LYON cedex 08 - Other - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive du Confluent - 44277 - Nantes Cedex 2 - Other - France | Contact (sur clinicalTrials) | ||||
| Hospitalier Jean Minjoz - 25030 - Besancon - Other - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.