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

Primary Purpose

Ovarian, Breast, SCLC

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Olaparib

MEDI4736

Bevacizumab

About this trial

This is an interventional treatment trial for Ovarian focused on measuring MEDIOLA, Olaparib, MEDI4736, Bevacizumab, Ovarian cancer, Breast cancer, Small Cell Lung Cancer, Gastric Cancer, Phase I/II, Adults, PDL-1

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

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.

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.

Secondary Outcome Measures

Second Stage Expansion Cohort: DCR at Week 24

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736

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

Initial and Second Stage Cohorts: Serum Concentrations of Olaparib

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

Second Stage Cohort: Serum Concentrations of Bevacizumab

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

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.

Full Information

NCT ID

NCT02734004

First Posted

March 17, 2016

Last Updated

October 12, 2023

Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02734004

Brief Title

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

Acronym

MEDIOLA

Official Title

A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 17, 2016 (Actual)

Primary Completion Date

September 17, 2021 (Actual)

Study Completion Date

September 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Iqvia Pty Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian, Breast, SCLC, Gastric Cancers

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

264 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Olaparib

Intervention Description

Olaparib

Intervention Type

Drug

Intervention Name(s)

MEDI4736

Intervention Description

MEDI4736

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab

Primary Outcome Measure Information:

Title

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

Description

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.

Title

Second Stage Cohort: Objective Response Rate (ORR)

Description

Time Frame

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Title

Second Stage Cohorts: DCR at Week 24

Description

Time Frame

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Secondary Outcome Measure Information:

Title

Second Stage Expansion Cohort: DCR at Week 24

Description

Time Frame

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Title

Initial Stage Cohorts: DCR at Week 28

Description

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.

Title

Second Stage Cohorts: DCR at Week 56

Description

Time Frame

RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.

Title

Initial and Second Stage Cohorts: ORR

Description

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

Title

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

Description

Time Frame

Title

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

Description

Time Frame

Title

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

Description

Time Frame

Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019

Title

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

Description

Time Frame

Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021

Title

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

Description

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

Title

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

Description

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

Title

Initial and Second Stage Cohorts: OS

Description

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

Title

Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736

Description

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

Title

Initial and Second Stage Cohorts: Serum Concentrations of Olaparib

Description

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

Title

Second Stage Cohort: Serum Concentrations of Bevacizumab

Description

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

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Domchek, MD

Organizational Affiliation

Abramson Cancer Center, University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

Research Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site

City

Hilliard

State/Province

Ohio

ZIP/Postal Code

43026

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Research Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Research Site

City

Caen Cedex 05

ZIP/Postal Code

14076

Country

France

Facility Name

Research Site

City

Clermont Ferrand cedex 01

ZIP/Postal Code

63011

Country

France

Facility Name

Research Site

City

Dijon cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Research Site

City

Marseille CEDEX 5

ZIP/Postal Code

13385

Country

France

Facility Name

Research Site

City

Nantes

ZIP/Postal Code

44202

Country

France

Facility Name

Research Site

City

Paris cedex 14

ZIP/Postal Code

75014

Country

France

Facility Name

Research Site

City

Pierre Benit Cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Villejuif Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Research Site

City

Haifa

ZIP/Postal Code

91096

Country

Israel

Facility Name

Research Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Research Site

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Research Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Research Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Research Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Research Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Research Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Research Site

City

Chur

ZIP/Postal Code

CH-7000

Country

Switzerland

Facility Name

Research Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Research Site

City

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE1 9RY

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Research Site

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35756843

Citation

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.

Results Reference

derived

PubMed Identifier

32771088

Citation

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.

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

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

Ovarian, Breast, SCLC

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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