Titre |
A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma |
Protocole ID |
INCMGA 0012-201 |
ClinicalTrials.gov ID |
NCT03599713 |
Type(s) de cancer |
Peau |
Phase |
Phase II |
Stade |
Métastatique |
Type étude |
Traitement |
Médicament |
INCMGA00012 |
Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Wilson Miller
|
Coordonnateur(trice) |
Ralph Waked
514-340-8222 poste 26823
|
Statut |
Fermé |
Critètes d'éligibilité |
- Signed informed consent.
- Diagnosis of MCC with distant metastatic disease as a component of tumor burden and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Measurable disease according to RECIST v1.1.
- Availability of tumor tissue (fresh or archival) for central pathology review.
- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
|
Critètes d'exclusion |
- Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
- Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
- Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- History of second malignancy within 3 years (with exceptions).
- Laboratory values outside the protocol-defined range at screening.
- Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
- Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
- Receipt of a live vaccine within 90 days of planned start of study therapy.
- Current use of protocol-defined prohibited medication.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
- Participant who is pregnant or breastfeeding.
|