| Titre |
A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma |
| Protocole ID |
V940-004 |
| ClinicalTrials.gov ID |
NCT06307431 |
| Type(s) de cancer |
Rein |
| Phase |
Phase II |
| Type étude |
Clinique |
| Médicament |
V940 + Pembrolizumab versus Placebo + Pembrolizumab |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DE L'ENFANT-JESUS
1401 18e Rue, Québec, QC, G1J 1Z4
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Louis Lacombe
|
| Coordonnateur(trice) |
Marilyn Savard
418-525-4444 poste 67703
|
| Statut |
 Actif en recrutement |
| Date d'activation |
10-04-2024 |
| Critètes d'éligibilité |
- Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
- Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
- Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
- High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
- M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)
- Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
- Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
|
| Critètes d'exclusion |
- Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
- Has residual thrombus post nephrectomy in the vena renalis or vena cava.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Received prior treatment with a cancer vaccine.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has a history of brain or bone metastatic lesions.
- Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- History of allogeneic tissue/solid organ transplant.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
|
Groupe d'étude en oncologie du Québec