Last updated on July 2019

A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

Brief description of study

The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7, 8 and 9) and MEDI4736 in combination with olaparib and bevacizumab (module 6 and 10). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

Detailed Study Description

This is a phase I/II open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of MEDI4736 in combination with olaparib in patients with advanced solid tumors, selected based on a rationale for response to olaparib.

Patients will be poly (adenosine diphosphate-ribose) polymerase (PARP)-inhibitor and immunotherapy (IMT)-nave (defined as no prior exposure to PARP inhibitors or IMT, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed cell death 1 [PD-1], anti-programmed death-ligand 1 [PD-L1] monoclonal antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

The 4 initial stage cohorts (Modules 1 to 4) include patients with relapsed small cell lung cancer (SCLC), germline BRCA mutated (gBRCAm) metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, gBRCAm platinum-sensitive relapsed ovarian cancer, and gastric cancer. Enrollment for these cohorts has been completed.

Second stage cohorts (Modules 5 to 7) will include patients with relapsed BRCAm platinum-sensitive relapsed ovarian cancer and non BRCAm platinum-sensitive relapsed ovarian cancer.

Third stage cohorts (Modules 8 to 10) will include patients with HER2-negative, BRCAm breast cancer (Module 8), HER2 negative, non BRCAm, Homologous Recombination Repair gene mutated (HRRm) breast cancer (Module 9) and non BRCAm, non HRRm triple negative breast cancer (TNBC) breast cancer (Module 10).

Clinical Study Identifier: NCT02734004

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Research Site

London, United Kingdom
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Recruitment Status: Open

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