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

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ClinicalTrials.gov Identifier: NCT02734004
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
AstraZeneca

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, 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.

Condition or disease Intervention/treatment Phase
Ovarian Breast SCLC Gastric Cancers Drug: Olaparib Drug: MEDI4736 Drug: Bevacizumab Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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. 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 427 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 17, 2016
Estimated Primary Completion Date : August 5, 2022
Estimated Study Completion Date : August 5, 2022


Arm Intervention/treatment
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) and 3rd stage cohorts (modules 8&9): 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) and 3rd stage cohort (module 10): 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




Primary Outcome Measures :
  1. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 [ Time Frame: At 12 weeks, compared to Baseline ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 1, 2, 3 and 4)

  2. The safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) by assessment of the number and grade of adverse events [ Time Frame: From screening up to 90 days after end of treatment ]
    Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03 (All modules)

  3. The safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) by assessment of physical examination [ Time Frame: From screening up to 30 days after end of treatment ]
    The physical examination is used as a means to detect and measure the frequency and severity of adverse events and medical conditions. Assessments of general appearance, head, eyes, ears, nose and throat; and the respiratory, cardiovascular, gastrointestinal, breast, urogenital, musculoskeletal, neurological, dermatological, hematologic/lymphatic and endocrine systems will be performed (All modules).

  4. The safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) by assessment of vital signs [ Time Frame: From screening up to 30 days after end of treatment ]
    Assessments of blood pressure, pulse, temperature, respiratory rate and electrocardiogram tests will be performed (All modules)

  5. The safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) by assessment of blood samples [ Time Frame: From screening up to 90 days after end of treatment ]
    Laboratory assessments of blood samples for hematology and coagulation variables, plus clinical chemistry parameters will be performed (All modules)

  6. ORR (CR + PR) based on RECIST 1.1, and as determined by investigator [ Time Frame: RECIST assessments performed at baseline and every 8 wks relative to baseline up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 5 and 8)

  7. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 [ Time Frame: At 24 weeks, compared to Baseline ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 6 and 7)

  8. DCR (CR+PR+SD) based on RECIST 1.1 [ Time Frame: at 16 weeks, compared to Beaseline ]
    Assessments will be done based on CT/MRI scans (Modules 9 and 10)


Secondary Outcome Measures :
  1. PD-L1 expression in serum samples [ Time Frame: Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 15 of cycle 1; Day 1 of cycle 3; Day 1 of cycle 5; Day 1 of cycle 7; 3 month Follow-up visit ]
    Samples will be measured for the presence of sPD-L1 (Modules 1, 2, 3 and 4)

  2. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 [ Time Frame: At 28 weeks, compared to Baseline ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 1, 2, 3 and 4) and BICR (Modules 2 and 3)

  3. Time to study treatment discontinuation (TDT) [ Time Frame: From Cycle 1, Day 1 until treatment discontinuation from any cause or until death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Time of study treatment discontinuation or death (All modules)

  4. Overall Survival (OS) [ Time Frame: From Cycle 1, Day 1 until death from any cause, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Time from start of Olaparib treatment until death due to any cause (All modules)

  5. Percentage change from baseline in tumor size [ Time Frame: At 12 weeks and 28 weeks compared to Baseline ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 1, 2, 3 and 4)

  6. Best percentage change from baseline in tumor size [ Time Frame: From Baseline, at 4 weeks (Modules 1, 2, 3 and 4) and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (All modules)

  7. Serum concentrations of anti-drug antibody (ADA) [ Time Frame: Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 15 of cycle 1; Day 1 of cycle 3; Day 1 of cycle 5; Day 1 of cycle 7; 3 month Follow-up visit ]
    Samples will be measured for the presence of MEDI4736 ADAs (All modules)

  8. Olaparib pharamacokinetic sample [ Time Frame: Olaparib Run-In treatment week 1 day 1; Olaparib Run-In treatment week 4 day 1; Day 15 of Cycle 1 ]
    Samples will be collected for determination of Olaparib levels in plasma (All modules)

  9. MEDI4736 pharmacokinetic sample [ Time Frame: Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 15 of cycle 1; Day 1 of cycle 3; Day 1 of cycle 5; Day 1 of cycle 7; 3 month Follow-up visit ]
    Samples will be collected for determination of MEDI4736 levels in plasma (All modules)

  10. Objective response rate (Complete response+Partial response) based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by BICR (Modules 5 and 8)

  11. Duration of response based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator and assessed by BICR (Modules 5 and 8)

  12. PFS based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator and assessed by BICR (Modules 5 and 8)

  13. Percentage change from baseline in tumor size [ Time Frame: At 24 weeks and 56 weeks compared to Baseline ]
    Assessments will be performed using CT/MRI assessments of the chest, abdomen, and pelvis (Modules 5, 6, 7, 8, 9 and 10)

  14. Objective response rate (Complete response+Partial response) based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 6, 7, 9 and 10)

  15. Duration of response based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 5, 6, 7, 8, 9 and 10)

  16. PFS based on RECIST 1.1 [ Time Frame: From Baseline, at 8 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 5, 6, 7, 8, 9 and 10)

  17. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 [ Time Frame: At 24 weeks and 56 weeks, compared to Baseline ]
    Assessed by the investigator and assessed by BICR (Module 5)

  18. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1 [ Time Frame: At 56 weeks, compared to Baseline ]
    Assessed by the investigator (Modules 6 and 7)

  19. Bevacizumab pharmacokinetic sample [ Time Frame: Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 1 of cycle 2; Day 1 of cycle 4; Day 1 of cycle 7 ]
    Samples will be collected for determination of bevacizumab levels in plasma (Module 6)

  20. Objective response rate (Complete response+Partial response) based on RECIST 1.1 [ Time Frame: From Baseline, at 4 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 1, 2, 3 and 4) and by BICR (Modules 2 and 3)

  21. Duration of response based on RECIST 1.1 [ Time Frame: From Baseline, at 4 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 1, 2, 3 and 4) and by BICR (Modules 2 and 3).

  22. PFS based on RECIST 1.1 [ Time Frame: From Baseline, at 4 weeks and every 8 weeks up to objective radiological progression, or death from any cause, whichever comes earlier, assessed until all patients receiving IP have completed 104 weeks of treatment. ]
    Assessed by the investigator (Modules 1, 2, 3 and 4) and by BICR (Modules 2 and 3).

  23. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] [ Time Frame: 16 weeks and 24 weeks ]
    Assessments done with CT/MRI scans (Module 8) assessed by investigator and by BICR.

  24. Disease control rate (DCR) [Complete response + Partial response + Stable disease (CR+PR+SD)] [ Time Frame: 24 weeks ]
    Assessments done with CT/MRI scans (Modules 9 and 10)

  25. Olaparib plasma concentrations [ Time Frame: Each cycle - 28 days; Day 15 of Cycle 1 ]
    PK (plasms) samples collected (Modules 8, 9 and 10)

  26. MEDI4736 serum concentrations [ Time Frame: Each cycle = 28 days; Day 1 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 4, Day of Cycle 7 (Modules 8, 9 and 10) ]
    PK (plasms) samples collected (Modules 8, 9 and 10).

  27. Bevacizumab serum concentrations [ Time Frame: Each cycle = 28 days; Day 1 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 4, Day of Cycle 7 (Module 10) ]
    PK (plasms) samples collected (Modules 8, 9 and 10).

  28. MEDI4736 ADA (Anti-drug Antigen) serum concentrations [ Time Frame: Each cycle = 28 days; Day 1 of Cycle 1, Day 1 of Cycle 4, Day of Cycle 7 (Modules 8, 9 and 10) ]
    PK (plasms) samples collected (Modules 8, 9 and 10).

  29. Bevacizumab ADA (Anti-drug Antigen) serum concentrations [ Time Frame: Each cycle = 28 days; Day 1 of Cycle 1, Day 1 of Cycle 4, Day of Cycle 7 (Module 10) ]
    PK (plasms) samples collected (Modules 8, 9 and 10).


Other Outcome Measures:
  1. Tumor genetics [ Time Frame: At Screening ]
    To determine presence of homologous recombination repair (BRCA1, BRCA2) ATM and overall mutation burden (All modules)

  2. Pharmacodynamics: Paired tumor biopsies [ Time Frame: Olaparib Run-In Treatment week 1 day1. Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 1 of Cycle 2 ]
    Tumor samples will be analyzed for biomarkers including CD8 expressing T cells, PD-L1 expression, measures of T-cell repertoire, gene expression and markers associated with immunogenic cell death (All modules)

  3. Pharmacodynamics: whole blood for gene expression (PAXgene-RNA) [ Time Frame: Olaparib Run-In Treatment week 1 day 1. Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 1 of Cycle 2; Day 1 of Cycle 3 ]
    angiogenic predictive biomarkers: may include but is not limited to tumor gene expression profiling, tumor vascular morphology/microvessel density and peripheral soluble markers of angiogenesis eg, VEGF, Ang-1 (Modules 5, 6 and 7)

  4. Pharmacodynamics: circulating soluble factors in the plasma [ Time Frame: Olaparib Run-In Treatment week 1 day 1. Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 1 of Cycle 2; Day 1 of Cycle 3; Day 1 of Cycle 6 ]
    The concentrations of a panel of cytokines and chemokines will be assessed. (All modules)

  5. Pharmacodynamics: whole blood for immunophenotyping [ Time Frame: Screening. Olaparib Run-In Treatment week 1 day 1. Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 15 of Cycle 1; Day 1 of Cycle 2; Day 1 of Cycle 3 ]
    Whole blood samples will be collected for flow cytometry-based immunophenotyping of circulating lymphocytes (All modules)

  6. Pharmacodynamics: peripheral blood mononuclear cells [ Time Frame: Olaparib Run-In treatment week 1 day 1. Olaparib Run-In treatment week 3 day 1. Each cycle = 28 days in combination of treatment. Day 1 of cycle 1; Day 15 of Cycle 1; Day 1 of Cycle 2; Day 1 of Cycle 3 ]
    Whole blood samples will be collected for preparation of PBMCs and storage for potential downstream analyses. (All modules)

  7. Pharmacogenetics [ Time Frame: Olaparib Run-In treatment week 1 day 1 ]
    Optional: patient consent required to collect and store DNA from blood (according to each country's local and ethical procedures) for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to study treatments and or susceptibility to disease (Optional)

  8. Characterize the pharmacodynamics profile of bevacizumab: Efficacy of bevacizumab in combination with olaparib and MEDI4736 compared to olaparib and MEDI4736 alone [ Time Frame: At baseline and upon progression ]
    Evaluation of plasma samples collected before treatment, longitudinally and upon progression including, but not limited to, VEGF (Modules 6 and 7)

  9. Angiogenic predictive biomarkers: may include but is not limited to tumor gene expression profiling, tumor vascular morphology/microvessel density and peripheral soluble markers of angiogenesis eg, VEGF, Ang-1 [ Time Frame: Since Screening and till week 104 ]
    To evaluate baseline measures and changes induced by olaparib alone and in combination with MEDI4736±bevacizumab, in peripheral blood, archival tumor, and tumor biopsies (frozen and fixed cores) (Modules 6, 7 and 10)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
    • BRCAm (including germline and tumor BRCA1/2 mutations) human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients with metastatic or locally advanced disease, which is unresectable (or the patient is not a candidate for resection) (Module 8 BRCAm)
    • Human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients with metastatic or locally advanced disease, which is unresectable (or the patient is not a candidate for resection) Patients must have documented evidence from Myriad central tumor testing that they do not have a mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) and do have a deleterious or suspected deleterious mutation in at least 1 of the following 13 HRR genes: ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L. (Module 9 HRRm).
    • Breast cancer patients with metastatic or locally advanced disease, which is unresectable (or the patient is not a candidate for resection). Patients must have documented evidence from Myriad central tumor testing that they do not have any mutation in BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) (Module 10 TNBC).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734004


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

  Show 53 Study Locations
Sponsors and Collaborators
AstraZeneca
Iqvia Pty Ltd
Investigators
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Principal Investigator: Susan Domcheck, MD Abramson Cancer Center, University of Pennsylvania

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02734004     History of Changes
Other Study ID Numbers: D081KC00001
2015-004005-16 ( EudraCT Number )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Keywords provided by AstraZeneca:
MEDIOLA
Olaparib
MEDI4736
Bevacizumab
Ovarian cancer
Breast cancer
Small Cell Lung Cancer
Gastric Cancer
Phase I/II, Adults
PDL-1
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Bevacizumab
Durvalumab
Olaparib
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors