Clinical Trial Development Program: An Immunotherapeutic Approach

The field of immuno-oncology is expanding rapidly, and immunotherapies that are designed to restore the immune response or overcome immune-suppressive signals are being investigated.1

AstraZeneca is committed to unlocking the potential of immuno-oncology and is evaluating multiple compounds for their potential effects on a range of tumor types.2 Select clinical trials are listed in the tables below.

Lung Cancer Clinical Trials2

PHASE I

Study 006 - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Advanced NSCLC
NCT02000947

TATTON - Durvalumab + Osimertinib
Anti–PD-L1 + EGFR T790M TKI
Advanced NSCLC
NCT02143466

Durvalumab + Gefitinib
Anti–PD-L1 + EGFR TKI
2L+Locally Advanced or Metastatic NSCLC
NCT02088112

PHASE II

Durvalumab Sequencing
Anti–PD-L1
Stage IIIB-IV NSCLC
NCT02179671

ATLANTIC - Durvalumab
Anti–PD-L1
Stage IIIB-IV NSCLC
NCT02087423

PHASE III

MYSTIC—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
1L NSCLC
NCT02453282

NEPTUNE—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
1L NSCLC
NCT02542293

PACIFIC—Durvalumab
Anti–PD-L1
Unresectable Stage III NSCLC
NCT02125461

ADJUVANT - Durvalumab
Anti–PD-L1
Adjuvant Resected NSCLC
NCT02273375

ARCTIC—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Stage IIIB-IV NSCLC
NCT02352948

Lung Master Protocol Durvalumab
Anti–PD-L1
Stage IV Squamous NSCLC
NCT02154490

CASPIAN - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
1L SCLC
NCT03043872

PEARL - Durvalumab vs SOC
Anti-PD-L1
1L NSCLC
NCT03003962

Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials2

PHASE I

Study 11 - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
HNSCC
NCT02262741

PHASE II

Durvalumab ± AZD9150 or AZD5069
Anti–PD-L1 ± STAT3 Inhibitor or CXCR2
Antagonist
2L HNSCC
NCT02499328

PHASE III

KESTREL—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
1L Recurrent or Metastatic HNSCC
NCT02551159

EAGLE—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
2L HNSCC
NCT02369874

Bladder Cancer Clinical Trial2

PHASE I

BISCAY - Durvalumab in Combination
Anti-PD-L1 + FGFR Inhibitor or PARP Inhibitor
or WEE-1 Inhibitor or mTORC Inhibitor
2L Muscle Invasive Bladder Cancer
NCT02546661

PHASE II

PHASE III

DANUBE—Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
1L Bladder
NCT02516241

Pancreatic Cancer Clinical Trials2

PHASE I

PHASE II

Durvalumab + AZD5069
Anti–PD-L1 + CXCR2 Antagonist
Metastatic Pancreatic Ductal Carcinoma
NCT02583477

PHASE III

Other Clinical Trials2

PHASE I

Durvalumab
Anti–PD-L1
Solid Tumors
NCT01938612

Durvalumab + Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Advanced Solid Tumors
NCT02261220

Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Advanced Solid Tumors
NCT02141347

MEDI0562
OX40-Agonist
Advanced Malignancies
NCT02318394

Durvalumab
Anti–PD-L1
Myelodysplastic Syndrome
NCT02117219

Durvalumab + MEDI0680
Anti–PD-L1 + Anti–PD-1
Advanced Malignancies
NCT02013804

Durvalumab + AZD6738
Anti-PD-L1 + ATR Inhibitor
Solid Tumors
NCT02264678

Durvalumab or Tremelimumab + Mogamulizumab
Anti-PD-L1 or Anti-CTLA-4 + Anti-CCR4
Solid Tumors
NCT02301130

Durvalumab + MEDI9447
Anti-PD-L1 + CD73 Inhibitor
Advanced Malignancies
NCT02503774

MEDI1873
GITR Agonist
Solid Tumors
NCT02583165

Durvalumab + Selumetinib
Anti-PD-L1 + MEK Inhibitor
Advanced Solid Tumors
NCT02586987

Durvalumab + AZD1775
Anti-PD-L1 + WEE-1 Inhibitor
Advanced Solid Tumors
NCT02617277

Durvalumab + Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Advanced Solid Tumors
NCT02658214

Durvalumab + Monalizumab
Anti-PD-L1 + Anti-NKG2A
Advanced Solid Tumors
NCT02671435

MEDI0562 + Durvalumab or Tremelimumab
OX40 Agonist + Anti-PD-L1 or Anti-CTLA-4
Advanced Malignancies
NCT02705482

Durvalumab + AZD4635
Anti-PD-L1 + A2AR Antagonist
Advanced Solid Tumors
NCT02740985

Durvalumab
Anti–PD-L1
Solid Tumors
NCT02900157

MEDI9197
TLR7/8 Agonist
Solid Tumors
NCT02556463

Durvalumab + MEDI0680
Anti–PD-L1 + Anti–PD-1
Advanced Malignancies
NCT02118337

Durvalumab ± MEDI5083
Anti-PD-L1 ± Immune Activator
Advanced Solid Tumors
NCT03089645

PHASE II

Durvalumab + Dabrafenib ± Trametinib
Anti-PD-L1 + BRAF Inhibitor or MEK Inhibitor
Metastatic or Unresectable Melanoma
NCT02027961

Study 21 - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
2L+ Gastric or GE Junction
NCT02340975

Study 1108 - Durvalumab
Anti–PD-L1
Solid Tumors
NCT01693562

Tremelimumab
Anti-CTLA-4
Various Tumors
NCT02527434

STUDY 23 - Durvalumab ± Tremelimumab ± AZD9150
Anti-PD-L1 + Anti-CTLA-4 or STAT3 Inhibitor
Diffuse Large B-cell Lymphoma
NCT02549651

MEDIOLA - Durvalumab + Olaparib Tablets
Anti-PD-L1 + PARP Inhibitor
Various Tumors
NCT02734004

STUDY 22 - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Hepatocellular Carcinoma
NCT02519348

PHASE III

STRONG - Durvalumab ± Tremelimumab
Anti–PD-L1 ± Anti–CTLA-4
Advanced Solid Malignancies
NCT03084471

For more information on our Immuno-Oncology Clinical Trial Development Program, please visit www.astrazenecaclinicaltrials.com

References: 1. Melero I, Grimaldi AM, Perez-Gracia JL, Ascierto PA. Clinical development of immunostimulatory monoclonal antibodies and opportunities for combination. Clin Cancer Res. 2013;19(5):997-1008. 2. AstraZeneca. Clinical trials appendix Q1 2017 results update. https://www.astrazeneca.com/content/dam/az/PDF/2017/QR1/Q1_2017_Results_Clinical_Trial_Appendix.pdf. Accessed May 10, 2017.