Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)
Interventional
Phase 1/Phase 2
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
mars 2024
octobre 2031
18 juillet 2025
Researchers are looking for new ways to treat people with high-risk muscle-invasive
urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins
in cells that line the inside of the bladder and other parts of the urinary tract, such
as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy
before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to
destroy cancer cells or stop them from growing. After surgery, some people receive more
treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a
treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an
antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers
treatment to destroy those cells. Researchers want to learn if giving intismeran autogene
(the study treatment) with pembrolizumab can prevent MIUC from returning after surgery.
Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by
helping the person's immune system identify and kill cancer cells based on certain
proteins found on those cancer cells.
The goals of this study are to learn if people who receive intismeran autogene and
pembrolizumab are alive and cancer free longer than those who receive placebo and
pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and
EV, and if people tolerate them.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hopital Claude Huriez - CHU de Lille ( Site 0301) - 59037 - Lille - Nord - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis ( Site 0304) - 75475 - Paris - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest ( Site 0300) - 49055 - ANGERS cedex 02 - Maine-et-Loire - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Regaud ( Site 0302) - 31059 - Toulouse - Haute-Garonne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has a histological diagnosis of urothelial carcinoma (UC)
- Must provide blood samples per protocol, to enable intismeran autogene production,
and circulating tumor deoxyribonucleic acid testing
- Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed
within 7 days before randomization
- Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next
generation sequencing
Adjuvant Cohort:
- Has MIUC
- Has high-risk pathologic disease after radical resection
- For participants who have not received cisplatin-based neoadjuvant chemotherapy, are
ineligible to receive cisplatin according to protocol pre-defined criteria
Perioperative Cohort:
- Has MIBC
- Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC
and PLND and neoadjuvant and adjuvant treatment per protocol
- Is ineligible to receive cisplatin according to protocol pre-defined criteria
The main inclusion criteria include but are not limited to the following:
- Has a histological diagnosis of urothelial carcinoma (UC)
- Must provide blood samples per protocol, to enable intismeran autogene production,
and circulating tumor deoxyribonucleic acid testing
- Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed
within 7 days before randomization
- Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next
generation sequencing
Adjuvant Cohort:
- Has MIUC
- Has high-risk pathologic disease after radical resection
- For participants who have not received cisplatin-based neoadjuvant chemotherapy, are
ineligible to receive cisplatin according to protocol pre-defined criteria
Perioperative Cohort:
- Has MIBC
- Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC
and PLND and neoadjuvant and adjuvant treatment per protocol
- Is ineligible to receive cisplatin according to protocol pre-defined criteria
The main exclusion criteria include but are not limited to the following:
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention
- Has known additional malignancy that is progressing or has required active treatment
≤3 years prior to study randomization
- Has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has active hepatitis B and hepatitis C virus infection
Adjuvant Cohort:
- Has received prior systemic anticancer therapy
- Has received prior neoadjuvant therapy, with the exception of neoadjuvant
cisplatin-based chemotherapy for MIUC
- Has severe hypersensitivity to either intismeran autogene or pembrolizumab (MK-3475)
and/or any of their excipients
Perioperative Cohort:
- Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation,
and/or radiation therapy treatment for MIBC
- Has severe hypersensitivity to either intismeran autogene, pembrolizumab, or EV
and/or any of their excipients
- Has ongoing sensory or motor neuropathy
- Has active keratitis or corneal ulcerations