Study identifier:D5660C00004
ClinicalTrials.gov identifier:NCT02499328
EudraCT identifier:2015-002525-19
CTIS identifier:N/A
A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
Advanced solid tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck
Phase 1/2
No
AZD9150, MEDI4736, AZD5069, tremelimumab (treme)
All
340
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
MedImmune Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A1: AZD9150 / MEDI4736 Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved. | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |
Experimental: Part A2: AZD5069 / MEDI4736 Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved. | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 |
Experimental: Part B1:AZD9150+MEDI4736:PDL1 pretreated Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival. | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |
Experimental: Part B2:AZD5069+MEDI4736:PDL1 pretreated Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival. | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 |
Experimental: Part B3: AZD9150+MED4736:naiive 2L Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival. | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |
Experimental: Part B4:AZD5069+MEDI4736:naiive patients Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival. | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 |
Experimental: Part B5: AZD9150 in naiive patients Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival | Drug: AZD9150 AZD9150 |
Experimental: Part B6:AZD5069 in naiive patients Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival | Drug: AZD5069 AZD5069 |
Experimental: Part A3: AZD5069/MEDI4736 Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 |
Experimental: Part A4: AZD9150/Treme/MEDI4736 Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 Drug: tremelimumab (treme) tremelimumab |
Experimental: Part A5: AZD5069/Treme/MEDI4736 Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD. | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 Drug: tremelimumab (treme) tremelimumab |
Experimental: Part A6: AZD9150/MEDI4736 Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD. | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |
Experimental: Part A7: AZD5069/MEDI4736 Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD. | Drug: MEDI4736 MEDI4736 Drug: AZD5069 AZD5069 |
Experimental: Part B7: AZD9150+MEDI4736: naiive 1L Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |
Experimental: Part B8: AZD9150 (every other week)+MEDI4736: naive 1L Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival | Drug: AZD9150 AZD9150 Drug: MEDI4736 MEDI4736 |