Study identifier:D081KC00001
ClinicalTrials.gov identifier:NCT02734004
EudraCT identifier:2015-004005-16
CTIS identifier:N/A
A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Olaparib (PARP inhibitor) in Patients with Advanced Solid Tumors
ovarian
Phase 1/2
No
Olaparib, MEDI4736, Bevacizumab
All
264
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
IQVIA (formerly QuintilesIMS)
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) and MEDI4736 in combination with olaparib and bevacizumab (module 6). 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.
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)-naïve (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. The data cut-off occurred once all 4 Modules had reached last patient first visit (LPFV) + 2 years and all 4 cohorts had observed a median value for PFS. Second stage cohorts (Modules 5 to 7) include patients with relapsed gBRCAm platinum-sensitive relapsed ovarian cancer and non gBRCAm platinum-sensitive relapsed ovarian cancer. The final data cut-off will be once Modules 6 and 7 have observed a median value for overall survival. At this timepoint, the clinical study database will close to new data.
Location
Location
Marseille CEDEX 5, France, 13385
Location
Toulouse Cedex 9, France, 31059
Location
Pierre Benit CEDEX, France, 69495
Location
Ramat Gan, Israel, 5265601
Location
Tel Aviv, Israel, 6423906
Location
Seoul, Republic of Korea, 03080
Location
Seoul, Republic of Korea, 05505
Location
Seongnam-si, Republic of Korea, 13620
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1 | Drug: Olaparib Olaparib Drug: MEDI4736 MEDI4736 |
Experimental: Arm 2 Includes 2nd stage cohorts (modules 5 & 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1 | Drug: Olaparib Olaparib Drug: MEDI4736 MEDI4736 |
Experimental: Arm 3 Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1 | Drug: Olaparib Olaparib Drug: MEDI4736 MEDI4736 Drug: Bevacizumab Bevacizumab Other Name: Avastin |
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