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WAVE: Durvalumab Long-Term Safety and Efficacy Study

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04078152
Collaborator
Iqvia Pty Ltd (Industry), Parexel (Industry), Medidata Solutions (Industry), CISCRP (Other)
163
Enrollment
116
Locations
2
Arms
37.8
Anticipated Duration (Months)
1.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
All involved know the identity of the intervention assignment.
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)
Actual Study Start Date :
Sep 5, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Durvalumab Monotherapy

Drug: Durvalumab
IV infusion q4w with 1500mg durvalumab until progressive disease
Other Names:
  • MEDI4736

    		•
    No Intervention: Off Treatment

    Follow up Only

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0) [Estimated to be up to 3 years]

      Type, frequency and severity of adverse events (including those treatment and post-treatment periods) will be listed according to CTCAE v5.0

    Secondary Outcome Measures

    1. Efficacy of durvalumab in terms of Overall Response Rate (ORR) in patients who undergo retreatment with durvalumab [3 years]

      The analysis of ORR will be based on investigator assessments using RECIST 1.1

    2. Efficacy of durvalumab in terms of Duration of Response (DOR) in patients who undergo retreatment with durvalumab [3 years]

      The analysis of DOR will be based on investigator assessments using RECIST 1.1

    3. Overall Survival (OS) [3 years]

      Assessments of Overall Survival will be made at periodic time points until death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patient must be 18 years or older, at the time of signing the ICF. For subjects aged < 20 years and enrolled in Japan, a written ICF should be obtained from the subject and his or her legally acceptable representative.

    2. Patient received durvalumab monotherapy and/or durvalumab containing combination in an AstraZeneca/MedImmune-sponsored parent clinical study that is approved for enrollment into this study.

    3. Patients who received durvalumab in combination with any other approved or investigational anticancer agents in the parent clinical study must have completed or discontinued all other anticancer therapy (beyond durvalumab regimen).

    4. Patient must be willing and able to provide written informed consent and to comply with scheduled visits and other study procedures.

    Exclusion Criteria:
    The following exclusion criteria apply only to patients receiving treatment or retreatment:

    1. Currently receiving treatment in another interventional study other than the parent clinical study or, for retreatment patients, received treatment during the follow up period with an agent other than durvalumab

    2. Any concurrent chemotherapy, IP, biologic or hormonal therapy for cancer treatment

    3. Experienced an immune-mediated or non-immune-mediated toxicity that led to permanent discontinuation of durvalumab in parent clinical study

    4. Diagnosis of a new primary malignancy since enrollment into the parent clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Fullerton California United States 92835
    2 Research Site Washington District of Columbia United States 20007
    3 Research Site Augusta Georgia United States 30912
    4 Research Site Baltimore Maryland United States 21201
    5 Research Site Minneapolis Minnesota United States 55407
    6 Research Site Saint Louis Missouri United States 63110
    7 Research Site Mineola New York United States 11501
    8 Research Site Chapel Hill North Carolina United States 27514
    9 Research Site Huntersville North Carolina United States 28078
    10 Research Site Greenville South Carolina United States 29605
    11 Research Site Nashville Tennessee United States 37203
    12 Research Site Dallas Texas United States 75251
    13 Research Site Rosario Argentina S2000KZE
    14 Research Site Box Hill Australia 3128
    15 Research Site Melbourne Australia 3000
    16 Research Site Brussels Belgium 1090
    17 Research Site Kortrijk Belgium 8500
    18 Research Site Leuven Belgium 3000
    19 Research Site Florianópolis Brazil 88034-000
    20 Research Site Ijuí Brazil 98700-000
    21 Research Site Porto Alegre Brazil 90035-903
    22 Research Site Sao Jose Do Rio Preto Brazil 15090-000
    23 Research Site Sofia Bulgaria 1612
    24 Research Site Calgary Alberta Canada T2N 4N2
    25 Research Site Toronto CA Canada M5G 2M9
    26 Research Site Newmarket Ontario Canada L3Y 2P9
    27 Research Site Sudbury Ontario Canada P3E 5J1
    28 Research Site Santiago Chile 7500000
    29 Research Site Olomouc Czechia 775 20
    30 Research Site Brest Cedex France 29609
    31 Research Site Lille France 59037
    32 Research Site Lyon Cedex 08 France 69373
    33 Research Site Dresden Germany 1307
    34 Research Site Hannover Germany 30625
    35 Research Site Holargos, Athens Greece 155 62
    36 Research Site Budapest Hungary 1121
    37 Research Site Miskolc Hungary 3526
    38 Research Site Chennai India 600006
    39 Research Site Haifa Israel 91096
    40 Research Site Bunkyo-ku Japan 113-8677
    41 Research Site Fukushima-shi Japan 960-1295
    42 Research Site Isehara-shi Japan 259-1193
    43 Research Site Izumi-shi Japan 594-0073
    44 Research Site Kishiwada-shi Japan 596-8501
    45 Research Site Koto-ku Japan 135-8550
    46 Research Site Nagaoka-shi Japan 940-2085
    47 Research Site Nagoya-shi Japan 466-8560
    48 Research Site Natori-shi Japan 981-1293
    49 Research Site Okayama-shi Japan 700-8558
    50 Research Site Osaka-shi Japan 541-8567
    51 Research Site Saga-shi Japan 840-8571
    52 Research Site Suita-shi Japan 565-0871
    53 Research Site Sunto-gun Japan 411-8777
    54 Research Site Tokushima-shi Japan 770-8503
    55 Research Site Yokohama-shi Japan 241-8515
    56 Research Site Daegu Korea, Republic of 41931
    57 Research Site Gwangju Korea, Republic of 61469
    58 Research Site Gyeongsangnam-do Korea, Republic of 52727
    59 Research Site Seo-Gu Korea, Republic of 49241
    60 Research Site Seongnam-si Korea, Republic of 13620
    61 Research Site Seoul Korea, Republic of 03080
    62 Research Site Seoul Korea, Republic of 03722
    63 Research Site Seoul Korea, Republic of 06351
    64 Research Site Kuching Malaysia 93586
    65 Research Site Amsterdam Netherlands 1066 CX
    66 Research Site Arnhem Netherlands 6815 AD
    67 Research Site Olsztyn Poland 10-357
    68 Research Site Łódź Poland 90-302
    69 Research Site Łódź Poland 93-509
    70 Research Site Craiova Romania 200347
    71 Research Site Suceava Romania 720237
    72 Research Site Arkhangelsk Russian Federation 163045
    73 Research Site Moscow Russian Federation 111123
    74 Research Site Moscow Russian Federation 115280
    75 Research Site Omsk Russian Federation 644013
    76 Research Site pos.Pesochnyi Russian Federation 197758
    77 Research Site Saint-Petersburg Russian Federation 197022
    78 Research Site Saint-Petersburg Russian Federation 197758
    79 Research Site Sremska Kamenica Serbia 21204
    80 Research Site Badalona Spain 08916
    81 Research Site Barcelona Spain 08028
    82 Research Site Barcelona Spain 08035
    83 Research Site Barcelona Spain 08041
    84 Research Site Girona Spain 17007
    85 Research Site Jaén Spain 23007
    86 Research Site Madrid Spain 28041
    87 Research Site Madrid Spain 28046
    88 Research Site Marbella Spain 29600
    89 Research Site Málaga Spain 29010
    90 Research Site Valencia Spain 46026
    91 Research Site Bellinzona Switzerland CH-6500
    92 Research Site Lausanne Switzerland 1011
    93 Research Site New Taipei Taiwan 23561
    94 Research Site Taichung Taiwan 40447
    95 Research Site Taichung Taiwan 40705
    96 Research Site Tainan Taiwan 704
    97 Research Site Taipei Taiwan 11217
    98 Research Site Bangkok Thailand 10330
    99 Research Site Songkhla Thailand 90110
    100 Research Site Adana Turkey 01120
    101 Research Site Istanbul Turkey 34098
    102 Research Site Chernivtsі Ukraine 58013
    103 Research Site Ivano-Frankivsk Ukraine 76018
    104 Research Site Kharkiv Ukraine 61070
    105 Research Site Kirovohrad Ukraine 25006
    106 Research Site Kryvyi Rih Ukraine 50048
    107 Research Site Kyiv Ukraine 03022
    108 Research Site Kyiv Ukraine 03115
    109 Research Site Kyiv Ukraine 8112
    110 Research Site Sumy Ukraine 40005
    111 Research Site Uzhhorod Ukraine 88014
    112 Research Site Vinnytsia Ukraine 21029
    113 Research Site London United Kingdom EC1A 7BE
    114 Research Site London United Kingdom WC1N 3BG
    115 Research Site Manchester United Kingdom M20 4BX
    116 Research Site Hanoi Vietnam 100000

    Sponsors and Collaborators

    • AstraZeneca
    • Iqvia Pty Ltd
    • Parexel
    • Medidata Solutions
    • CISCRP

    Investigators

    • Principal Investigator: Jared Weiss, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04078152
    Other Study ID Numbers:
    • D910FC00001
    First Posted:
    Sep 4, 2019
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AstraZeneca
    non-small cell lung cancer (NSCLC)
    urothelial cancer
    durvalumab
    long-term safety, efficacy
    overall survival
    immunotherapy
    checkpoint inhibitor
    PD-L1
    retreatment
    Gastric adenocarcinoma
    Additional relevant MeSH terms:
    Durvalumab

    Study Results

    No Results Posted as of Aug 4, 2022