Dana Farber Cancer Institute 02215 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Barry Anderson E-Mail: banderson@theradex.com
Kartik Sehgal E-Mail: Kartik_Sehgal@DFCI.HARVARD.EDU» Ansprechpartner anzeigenMassey Cancer Center 23219 Richmond United StatesRekrutierend» Google-Maps Ansprechpartner: Carrie Donovan E-Mail: cdonovan2@vcu.edu» Ansprechpartner anzeigenMelanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital Sydney 2060 Sydney AustraliaRekrutierend» Google-Maps Ansprechpartner: Karen Bush E-Mail: ealong@melanoma.org.au» Ansprechpartner anzeigenPeter MacCallum Cancer Centre 3VIC 3000 Melbourne AustraliaRekrutierend» Google-Maps Ansprechpartner: Maria Vassiliou, Dr Phone: (03)85595000 E-Mail: Maria.Vassiliou@petermac.org
Tina Kusk E-Mail: tinakk@auh.rm.dk» Ansprechpartner anzeigenCopenhagen University Hospital Herlev 9 DK-2730 Copenhagen DenmarkRekrutierend» Google-Maps Ansprechpartner: Signe Reinhold E-Mail: signe.rud.reinhold@regionh.dk» Ansprechpartner anzeigenCHRU Lille 59037 Lille Lille FranceRekrutierend» Google-Maps Ansprechpartner: Sylvie Brice E-Mail: sylvie.brice@chu-lille.fr» Ansprechpartner anzeigenHôpital Ambroise-Paré 92104 Boulogne Paris FranceRekrutierend» Google-Maps Ansprechpartner: Veronique Clerisse E-Mail: veronique.clerisse@aphp.fr» Ansprechpartner anzeigenInstitut Gustave Roussy 94805 Villejuif Paris FranceRekrutierend» Google-Maps Ansprechpartner: Myriam Maalej-Chaari E-Mail: myriam.maalej-chaari@gustaveroussy.fr» Ansprechpartner anzeigenHospital Universitario Quirón Dexeus 08028 Barcelona Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Carlos Esparre E-Mail: Carlos Esparre
Alba Silvestre E-Mail: asilvestre@oncorosell.com» Ansprechpartner anzeigenHospital Universitario Ramón y Cajal Madrid 28034 Madrid SpainRekrutierend» Google-Maps Ansprechpartner: Lucia Castillon E-Mail: lcastillon@salud.madrid.org
Pardo de Vera E-Mail: bpardo@salud.madrid.org» Ansprechpartner anzeigenHospital Clínico Universitario de Valencia -INCLIVA 46010 Valencia Valencia SpainRekrutierend» Google-Maps Ansprechpartner: Inma Blasco E-Mail: Inma Blasco
1. Major pathologic response (Time Frame - Observed in the resected tumor tissue after neoadjuvant treatment at surgery): Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
Secondary outcome:
1. Pathologic complete response (Time Frame - Observed in the resected tumor tissue after neoadjuvant treatment at surgery): Pathologic complete response (pCR) (0% residual viable tumor)
2. Pathologic tumor response (Time Frame - Pathologic tumor response of the surgical specimens will be assessed at the time of surgery.): Pathologic tumor response (≤ 49% residual viable tumor) at surgery
3. Objective response rate (Time Frame - Determined after 9 weeks of treatment): Objective response rate (ORR), determined by RECIST 1.1
4. Disease-free survival (Time Frame - at 2 years after surgery): Disease-free survival (DFS) from the date of surgery
5. Event-free survival (Time Frame - Determined after 9 weeks of treatment): Event-free-survival (EFS)
6. Event-free survival (Time Frame - at 2 years after surgery): Event-free-survival (EFS)
Experimental: Cohort A - Melanoma Cutaneous resectable Stage III melanoma.
Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.
Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.
Experimental: Cohort B - SCCHN Stage III or IVA resectable locoregionally advanced Squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx (HPV-negative), hypopharynx, or larynx
Neoadjuvant Treatment (2-3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.
Experimental: Cohort C Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus intravenous Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B) Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B)
IO102-IO103: IO102-IO103 is a combination of an indoleamine 2,3-dioxygenase 1 (IDO1) peptide (IO102) and a programmed death-ligand 1 (PD-L1) peptide (IO103), emulsified with an adjuvant (Montanide ISA 51 VG).