Active, not recruitingNCT02734004MEDIOLAUpdated Jul 14, 2026Results posted

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

A Phase 1/2 interventional study of Olaparib and MEDI4736 in Ovarian, Breast and SCLC, sponsored by AstraZeneca. Active, not recruiting at 47 sites in 7 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by AstraZeneca · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 264
Allocation: Non-randomized
Ages: 18 Years to 130 Years
Sex: All

Study summary

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.

Read the detailed 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)-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.

Conditions studied

Ovarian
Breast
SCLC
Gastric Cancers

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Keywords

MEDIOLA
Olaparib
MEDI4736
Bevacizumab
Ovarian cancer
Breast cancer
Small Cell Lung Cancer
Gastric Cancer
Phase I/II, Adults
PDL-1

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's enrollment of 264 is above the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 130 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must have histologically or cytologically confirmed progressive advanced or metastatic solid tumor of one of the following:
- Platinum sensitive relapsed small cell lung cancer (module 1)
- gBRCAm HER2-negative metastatic breast cancer (module 2)
- gBRCAm ovarian cancer (modules 3 and 5)
- Metastatic or relapsed Gastric cancer (adenocarcinoma) (module 4)
- gBRCAm negative ovarian cancer (modules 6 and 7)
At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (or magnetic resonance imaging [MRI] suitable for assessment as per RECIST 1.1. The baseline scan must be obtained within 28 days prior to the first dose of olaparib.
Male or female patients, age ≥18 years (≥19 years for South Korea)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥12 weeks
Adequate organ and marrow function
Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of olaparib, which is an oral agent. For the gastric cancer cohort, patients with a full or partial gastrectomy will be permitted.
Ability of patient to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations.
Female patients must either:
- Be of non-reproductive potential OR
- Have a negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1, and agree to use contraception if they or their partner are of reproductive potential

Exclusion criteria

Prior chemotherapy or other systemic anticancer therapy within 4 weeks prior to start of olaparib treatment, 6 weeks for nitrosoureas or mitomycin. Exceptions include: Anti-hormonal treatment for ER positive or PR positive breast cancer is allowed until 7 days prior to treatment with olaparib, exposure to an investigational agent within 30 days or 5 half-lives (whichever is the longer) prior to start of olaparib treatment is not allowed, prior receipt of biologics targeting T cell co-regulatory proteins and/or immune checkpoints is not allowed. Examples include MEDI4736 or other PD1 or PD-L1 or PD-L2 inhibitors or anti-CTLA4 therapy, previous treatment with a PARP inhibitor, is not allowed.
Radiation therapy within 4 weeks prior to start of olaparib treatment (includes radiation targeting bone metastases) or radionuclide treatment within 6 weeks of treatment start.
Current dependency on total parenteral nutrition or IV fluid hydration.
Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. Concomitant use of known strong or moderate CYP3A inducers.
Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids.
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
Whole blood transfusions in the last 120 days
Patients with symptomatic or uncontrolled brain metastases.
Patients being considered at poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease.
Any psychiatric disorder that prohibits obtaining informed consent
Major surgery or significant traumatic injury within 2 weeks of run-in
Immunocompromised patients
QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment
Pregnant and breastfeeding women are excluded.
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous enrolment in the present study
Participation in a clinical study within 28 days or 5 half-lives of the drug, whichever is longer.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 264 participants (actual)

Study arms

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 · Drug: 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 · Drug: 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 · Drug: MEDI4736 · Drug: Bevacizumab

Interventions

DrugOlaparib
Olaparib
DrugMEDI4736
MEDI4736
DrugBevacizumab
Bevacizumab
Also known as: Avastin

What researchers measure

Primary outcomes

Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Second Stage Cohort: Objective Response Rate (ORR)
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
Time frame: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Second Stage Cohorts: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Time frame: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Secondary outcomes

Second Stage Expansion Cohort: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Time frame: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Initial Stage Cohorts: DCR at Week 28
The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Time frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Second Stage Cohorts: DCR at Week 56
The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Time frame: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Initial and Second Stage Cohorts: ORR
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
Time frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Duration of Response (DoR)
The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.
Time frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Progression-Free Survival (PFS)
The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.
Time frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.
Time frame: Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019
Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.
Time frame: Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021
Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size
The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.
Time frame: From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)
The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.
Time frame: From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: OS
The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.
Time frame: From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Blood samples were collected to determine the serum concentration of MEDI4736.
Time frame: Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Blood samples were collected to determine the serum concentration of olaparib.
Time frame: Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Second Stage Cohort: Serum Concentrations of Bevacizumab
Blood samples were collected to determine the serum concentration of bevacizumab.
Time frame: Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Time frame: Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively

Results

Posted Oct 13, 2023

Participant flow

This Phase I/II open-label study was conducted in participants with advanced solid tumors at 43 centers in France, the United Kingdom, the Republic of Korea, the USA, the Netherlands, Israel, and Switzerland. Initial stage cohorts: Results are reported for analysis with assessment until data cut-off (DCO) of 14 Jun 2019 \[except for overall survival (OS) for ovarian cancer cohort (DCO: 17 Sep 2021)\]. Second stage cohorts: Results are reported for analysis with assessment until DCO of 17 Sep 2021.

Participant flow — Overall Study
Milestone	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Started	40	34	34	40	51	31	32
Completed	0	0	0	0	0	0	0
Not completed	40	34	34	40	51	31	32
Withdrew: Death	36	24	26	35	13	17	20
Withdrew: Lost to follow-up	1	1	0	0	1	0	0
Withdrew: Withdrawal by subject	3	1	1	1	3	0	2
Withdrew: Other	0	8	7	4	34	14	10

Outcome measures

PrimaryInitial Stage Cohorts: Disease Control Rate (DCR) at Week 12

The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Time frame:: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Reported as:: Number · percentage of participants

Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
percentage of participants	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer
Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12	28.9	80.0	81.3	25.6

PrimarySecond Stage Cohort: Objective Response Rate (ORR)

The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.

Time frame:: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Reported as:: Number · percentage of participants

Second Stage Cohort: Objective Response Rate (ORR)
percentage of participants	Second Stage: Ovarian Cancer Expansion
Second Stage Cohort: Objective Response Rate (ORR)	92.2 (81.12 to 97.82)

PrimarySecond Stage Cohorts: DCR at Week 24

The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Time frame:: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Reported as:: Number · percentage of participants

Second Stage Cohorts: DCR at Week 24
percentage of participants	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Second Stage Cohorts: DCR at Week 24	74.2	28.1

SecondarySecond Stage Expansion Cohort: DCR at Week 24

Time frame:: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Reported as:: Number · percentage of participants

Second Stage Expansion Cohort: DCR at Week 24
percentage of participants	Second Stage: Ovarian Cancer Expansion
Second Stage Expansion Cohort: DCR at Week 24	88.2

SecondaryInitial Stage Cohorts: DCR at Week 28

The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Time frame:: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Reported as:: Number · percentage of participants

Initial Stage Cohorts: DCR at Week 28
percentage of participants	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer
Initial Stage Cohorts: DCR at Week 28	5.3	50.0	65.6	7.7

SecondarySecond Stage Cohorts: DCR at Week 56

The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.

Time frame:: RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Reported as:: Number · percentage of participants

Second Stage Cohorts: DCR at Week 56
percentage of participants	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Second Stage Cohorts: DCR at Week 56	41.2	38.7	9.4

SecondaryInitial and Second Stage Cohorts: ORR

The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.

Time frame:: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Number · percentage of participants

Initial and Second Stage Cohorts: ORR
percentage of participants	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: ORR	10.5 (2.94 to 24.80)	63.3 (43.86 to 80.07)	71.9 (53.25 to 86.25)	10.3 (2.87 to 24.22)	87.1 (70.17 to 96.37)	34.4 (18.57 to 53.19)

SecondaryInitial and Second Stage Cohorts: Duration of Response (DoR)

The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.

Time frame:: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Median · months

Initial and Second Stage Cohorts: Duration of Response (DoR)
months	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: Duration of Response (DoR)	3.6 (2.6 to 4.6)	9.2 (5.5 to 20.3)	10.2 (5.7 to 22.3)	14.8 (6.4 to NA)	14.8 (9.0 to NA)	11.1 (7.4 to 22.1)	6.9 (5.4 to 11.1)

SecondaryInitial and Second Stage Cohorts: Progression-Free Survival (PFS)

The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.

Time frame:: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Median · months

Initial and Second Stage Cohorts: Progression-Free Survival (PFS)
months	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: Progression-Free Survival (PFS)	2.4 (0.9 to 3.0)	8.2 (4.6 to 11.8)	12.0 (8.2 to 15.9)	2.6 (1.4 to 2.8)	15.0 (12.9 to 24.1)	14.7 (9.2 to 18.1)	5.5 (3.6 to 7.5)

SecondaryInitial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28

The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.

Time frame:: Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019
Reported as:: Mean · percentage change in tumor size

Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
percentage change in tumor size	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer
Week 12	17.23 ± 54.752	-26.13 ± 43.033	-35.86 ± 29.791	20.81 ± 75.944
Week 28	-2.05 ± 15.671	-40.85 ± 39.541	-53.74 ± 31.147	-41.00 ± 43.625

SecondarySecond Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56

Time frame:: Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021
Reported as:: Mean · percentage change in tumor size

Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
percentage change in tumor size	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Week 24	-66.30 ± 26.672	-43.00 ± 32.432	-35.63 ± 34.001
Week 56	-77.74 ± 26.472	-60.00 ± 29.058	-39.54 ± 33.719

SecondaryInitial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size

The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.

Time frame:: From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Mean · percentage change in tumor size

Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size
percentage change in tumor size	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size	6.27 ± 32.398	-47.60 ± 36.823	-55.55 ± 35.789	1.64 ± 42.338	-72.78 ± 31.497	-53.30 ± 33.317	-20.42 ± 41.160

SecondaryInitial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)

The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.

Time frame:: From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Median · months

Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)
months	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)	2.8 (2.0 to 3.8)	7.8 (6.2 to 12.1)	13.1 (8.2 to 15.9)	2.8 (2.1 to 3.2)	19.3 (14.7 to 26.2)	15.9 (10.3 to 18.4)	6.6 (4.4 to 8.5)

SecondaryInitial and Second Stage Cohorts: OS

The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.

Time frame:: From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts
Reported as:: Median · months

Initial and Second Stage Cohorts: OS
months	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Initial and Second Stage Cohorts: OS	7.6 (5.6 to 8.8)	20.5 (16.2 to 25.5)	35.5 (27.2 to 50.7)	6.4 (4.3 to 9.1)	NA (NA to NA)	31.9 (22.1 to NA)	26.1 (18.7 to NA)

SecondaryInitial and Second Stage Cohorts: Serum Concentrations of MEDI4736

Blood samples were collected to determine the serum concentration of MEDI4736.

Time frame:: Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Geometric mean · microgram per milliliter (mcg/mL)

Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
microgram per milliliter (mcg/mL)	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Day 1: Pre-dose	NA ± NA	NA ± NA	NA ± NA	NA ± NA	NA ± NA	NA ± NA	NA ± NA
Day 1: End of infusion	483.5 ± 35.09	542.5 ± 36.04	417.9 ± 33.48	391.8 ± 25.09	409.3 ± 33.27	498.8 ± 30.27	397.1 ± 18.53
Day 29: Pre-dose	—	—	—	—	93.56 ± 54.83	96.50 ± 34.67	78.23 ± 56.60
Day 57: Pre-dose	144.7 ± 38.96	165.2 ± 40.31	171.3 ± 31.73	114.7 ± 44.78	—	—	—
Day 85: Pre-dose	—	—	—	—	152.8 ± 50.14	145.2 ± 55.71	142.8 ± 63.07
Day 85: End of infusion	—	—	—	—	610.6 ± 39.64	589.3 ± 35.48	482.9 ± 44.01
Day 113: Pre-dose	119.5 ± 44.27	220.7 ± 35.97	231.3 ± 33.45	196.9 ± 74.60	—	—	—
Day 113: End of infusion	504.8 ± 25.24	671.5 ± 31.79	585.5 ± 52.67	679.1 ± 34.80	—	—	—
Day 169: Pre-dose	133.1 ± 30.74	231.5 ± 41.14	261.6 ± 45.92	230.7 ± 35.81	206.3 ± 61.24	162.6 ± 95.86	186.6 ± 65.36
90 days post last dose	6.907 ± 297.9	12.24 ± 4720	22.35 ± 120.9	17.23 ± 155.2	17.94 ± 331.8	17.47 ± 78.93	20.50 ± 340.0

SecondaryInitial and Second Stage Cohorts: Serum Concentrations of Olaparib

Blood samples were collected to determine the serum concentration of olaparib.

Time frame:: Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Geometric mean · mcg/mL

Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
mcg/mL	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Monotherapy - Day 1: Pre-dose	NA ± NA	NA ± NA	NA ± NA	NA ± NA	—	—	—
Monotherapy - Day 1: 0.5-1 hour postdose	3.647 ± 394.2	2.093 ± 1217	5.016 ± 150.1	2.321 ± 291.7	—	—	—
Monotherapy - Day 22: Pre-dose	1.374 ± 814.4	0.8500 ± 1501	1.242 ± 534.6	2.053 ± 124.6	—	—	—
Monotherapy - Day 22: 0.5-1 hour postdose	7.212 ± 55.84	5.370 ± 100.9	6.130 ± 144.9	5.350 ± 75.21	—	—	—
Combination therapy - Day 15: Pre-dose	1.848 ± 172.3	0.6526 ± 847.8	1.773 ± 92.68	1.744 ± 103.7	1.544 ± 102.3	1.400 ± 423.2	0.9718 ± 663.6
Combination therapy - Day 15: 0.5-1 hour postdose	5.008 ± 74.54	2.805 ± 234.2	4.288 ± 136.4	3.226 ± 60.08	5.439 ± 70.73	5.922 ± 98.89	6.549 ± 72.47
Combination therapy - Day 15: 1-3 hour postdose	8.038 ± 38.24	4.018 ± 155.6	5.897 ± 90.04	4.804 ± 57.38	—	7.644 ± 55.09	—
Combination therapy - Day 15: 3-6 hour postdose	7.811 ± 38.68	5.217 ± 51.57	6.322 ± 43.84	5.491 ± 35.36	—	5.717 ± 57.30	—
Combination therapy - Day 15: 6-12 hour postdose	5.186 ± 49.67	2.820 ± 60.56	3.661 ± 57.35	3.679 ± 52.80	—	3.023 ± 74.63	—

SecondarySecond Stage Cohort: Serum Concentrations of Bevacizumab

Blood samples were collected to determine the serum concentration of bevacizumab.

Time frame:: Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021
Reported as:: Geometric mean · mcg/mL

Second Stage Cohort: Serum Concentrations of Bevacizumab
mcg/mL	Second Stage: Ovarian Cancer Triplet
Day 1: Pre-dose	NA ± NA
Day 1: End of infusion	243.7 ± 30.01
Day 29: Pre-dose	104.6 ± 29.30
Day 85: Pre-dose	145.5 ± 28.26
Day 85: End of infusion	364.0 ± 23.74
Day 169: Pre-dose	147.9 ± 118.0
90 days post last dose	5.094 ± 224.1

SecondaryInitial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at \>=2 post-baseline assessments (with \>=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.

Time frame:: Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Reported as:: Count of participants · Participants

Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Participants	Initial Stage: Breast Cancer	Second Stage: Ovarian Cancer Expansion
ADA prevalence	1	—
ADA incidence	0	—
ADA positive post-baseline and positive at baseline	0	—
ADA positive post-baseline and not detected at baseline	0	—
ADA not detected post-baseline and positive at baseline	0	—
Treatment-boosted ADA	0	—
Persistent positive	0	—
Transient positive	0	—
Any nAb positive among any ADA positive	0	—

Adverse events

Collected over Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Initial Stage: Small Cell Lung Cancer	36/40 (90%)	23/40 (57.5%)	40/40 (100%)
Initial Stage: Breast Cancer	24/34 (70.6%)	4/34 (11.8%)	34/34 (100%)
Initial Stage: Ovarian Cancer	26/34 (76.5%)	10/34 (29.4%)	32/34 (94.1%)
Initial Stage: Gastric Cancer	35/40 (87.5%)	10/40 (25%)	40/40 (100%)
Second Stage: Ovarian Cancer Expansion	13/51 (25.5%)	13/51 (25.5%)	50/51 (98%)
Second Stage: Ovarian Cancer Triplet	17/31 (54.8%)	6/31 (19.4%)	31/31 (100%)
Second Stage: Ovarian Cancer Doublet	20/32 (62.5%)	8/32 (25%)	32/32 (100%)

Most frequent serious events

Showing 10 of 90

Most frequent serious events
Event	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	3/40	0/34	0/34	0/40	0/51	0/31	0/32
PneumoniaInfections and infestations	2/40	0/34	1/34	0/40	0/51	0/31	0/32
Atrial fibrillationCardiac disorders	2/40	0/34	0/34	0/40	0/51	0/31	0/32
DysphagiaGastrointestinal disorders	0/40	0/34	0/34	2/40	0/51	0/31	0/32
PneumoniaInfections and infestations	2/40	0/34	1/34	0/40	0/51	1/31	1/32
AnaemiaBlood and lymphatic system disorders	1/40	1/34	0/34	0/40	2/51	0/31	0/32
Intestinal perforationGastrointestinal disorders	0/40	0/34	0/34	0/40	0/51	1/31	0/32
Febrile neutropeniaBlood and lymphatic system disorders	1/40	0/34	0/34	0/40	0/51	1/31	1/32
IleusGastrointestinal disorders	1/40	0/34	1/34	0/40	0/51	1/31	0/32
Lower respiratory tract infectionInfections and infestations	1/40	0/34	0/34	0/40	0/51	1/31	1/32

Most frequent other events

Showing 10 of 144

Most frequent other events
Event	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet
NauseaGastrointestinal disorders	18/40	20/34	26/34	20/40	34/51	23/31	28/32
AnaemiaBlood and lymphatic system disorders	29/40	14/34	19/34	15/40	25/51	18/31	13/32
FatigueGeneral disorders	16/40	22/34	20/34	11/40	28/51	16/31	16/32
VomitingGastrointestinal disorders	12/40	11/34	14/34	17/40	20/51	16/31	4/32
DiarrhoeaGastrointestinal disorders	9/40	12/34	12/34	11/40	17/51	12/31	14/32
ConstipationGastrointestinal disorders	14/40	10/34	11/34	16/40	21/51	8/31	8/32
Decreased appetiteMetabolism and nutrition disorders	14/40	5/34	10/34	15/40	10/51	12/31	9/32
HeadacheNervous system disorders	9/40	7/34	6/34	4/40	8/51	11/31	7/32
Weight decreasedInvestigations	6/40	3/34	8/34	14/40	12/51	7/31	3/32
DyspnoeaRespiratory, thoracic and mediastinal disorders	12/40	3/34	11/34	2/40	13/51	4/31	4/32

Baseline characteristics

The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).

Age, Categorical
Age, Categorical(Participants)	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet	Total
<=18 years	0	0	0	0	0	0	0	0
Between 18 and 65 years	23	29	27	29	38	17	12	175
>=65 years	15	1	5	10	13	14	20	78

Sex: Female, Male
Sex: Female, Male(Participants)	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet	Total
Female	17	29	32	13	51	31	32	205
Male	21	1	0	26	0	0	0	48

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet	Total
White	21	17	22	24	34	20	24	162
Black or African American	0	0	0	0	1	0	0	1
Asian	6	7	6	13	12	10	3	57
Other	0	0	0	0	0	1	0	1
Missing	11	6	4	2	4	0	5	32

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Initial Stage: Small Cell Lung Cancer	Initial Stage: Breast Cancer	Initial Stage: Ovarian Cancer	Initial Stage: Gastric Cancer	Second Stage: Ovarian Cancer Expansion	Second Stage: Ovarian Cancer Triplet	Second Stage: Ovarian Cancer Doublet	Total
Hispanic or Latino	0	0	0	0	0	1	0	1
Not Hispanic or Latino	27	24	28	37	47	30	27	220
Missing	11	6	4	2	4	0	5	32

Study locations

47 sites

Research Site
Newnan, Georgia 30265, United States
Research Site
Towson, Maryland 21204, United States
Research Site
Boston, Massachusetts 02114, United States
Research Site
Detroit, Michigan 48202, United States
Research Site
St Louis, Missouri 63110, United States
Research Site
Hilliard, Ohio 43026, United States
Research Site
Philadelphia, Pennsylvania 19104, United States
Research Site
Bordeaux, 33076, France
Research Site
Caen, 14076, France
Research Site
Clermont-Ferrand, 63011, France
Research Site
Dijon, 21079, France
Research Site
Marseille, 13385, France
Research Site
Nantes, 44202, France
Research Site
Paris, 75014, France
Research Site
Pierre Benit Cedex, 69495, France
Research Site
Toulouse, 31059, France
Research Site
Villejuif, 94805, France
Research Site
Haifa, 91096, Israel
Research Site
Jerusalem, 91031, Israel
Research Site
Petah Tikva, 49100, Israel
Research Site
Ramat Gan, 5265601, Israel
Research Site
Tel Aviv, 6423906, Israel
Research Site
Amsterdam, 1066 CX, Netherlands
Research Site
Amsterdam, 1081 HV, Netherlands
Research Site
Maastricht, 6229 HX, Netherlands
Research Site
Nijmegen, 6525 GA, Netherlands
Research Site
Rotterdam, 3075 EA, Netherlands
Research Site
Utrecht, 3584 CX, Netherlands
Research Site
Goyang-si, 10408, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06273, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 135-710, South Korea
Research Site
Chur, CH-7000, Switzerland
Research Site
Lausanne, 1011, Switzerland
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
Glasgow, G12 0YN, United Kingdom
Research Site
Greater London, SW3 6JJ, United Kingdom
Research Site
London, NW1 2PG, United Kingdom
Research Site
London, SE1 9RY, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom

References and documents

Publications

Drew Y, Kim JW, Penson RT, O'Malley DM, Parkinson C, Roxburgh P, Plummer R, Im SA, Imbimbo M, Ferguson M, Rosengarten O, Steeghs N, Kim MH, Gal-Yam E, Tsoref D, Kim JH, You B, De Jonge M, Lalisang R, Gort E, Bastian S, Meyer K, Feeney L, Baker N, Ah-See ML, Domchek SM, Banerjee S; MEDIOLA Investigators. Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naive Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study. Clin Cancer Res. 2024 Jan 5;30(1):50-62. doi: 10.1158/1078-0432.CCR-23-2249. PubMed 37939124 ↗
Staniszewska AD, Armenia J, King M, Michaloglou C, Reddy A, Singh M, San Martin M, Prickett L, Wilson Z, Proia T, Russell D, Thomas M, Delpuech O, O'Connor MJ, Leo E, Angell H, Valge-Archer V. PARP inhibition is a modulator of anti-tumor immune response in BRCA-deficient tumors. Oncoimmunology. 2022 Jun 18;11(1):2083755. doi: 10.1080/2162402X.2022.2083755. eCollection 2022. PubMed 35756843 ↗
Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6. PubMed 32771088 ↗

Study documents

Study protocol · Dec 17, 2020
Statistical analysis plan · Jul 18, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02734004
Lead sponsor: AstraZeneca
Collaborators: IQVIA Pty Ltd
Responsible party: Sponsor
First posted: Apr 12, 2016
Start date: Mar 17, 2016
Primary completion: Sep 17, 2021
Completion: Sep 17, 2026 (estimated)
Results posted: Oct 13, 2023
Last update: Jul 14, 2026

Study contacts

Susan Domchek, MD

principal investigator · Abramson Cancer Center, University of Pennsylvania

Oversight

Data monitoring committee: No

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