Clinical trial NCT04078152: Durvalumab Long-Term Safety and Efficacy Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Solid Tumor
Keywords: non-small cell lung cancer (NSCLC)
urothelial cancer
durvalumab
long-term safety, efficacy
overall survival
immunotherapy
checkpoint inhibitor
PD-L1
retreatment
Gastric adenocarcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
name: Parexel
name: Medidata Solutions
name: CISCRP
First posted: 2019-09-04
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months
Secondary outcomes:
measure: Cohort 2: Overall Response Rate (ORR)
timeFrame: Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
measure: Cohort 2: Duration of Response (DOR)
timeFrame: Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
measure: Number of Participants Who Were Alive
timeFrame: Up to approximately 37 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Mineola
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Rosario
country: Argentina
facility: Research Site
city: Box Hill
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Florianópolis
country: Brazil
facility: Research Site
city: Ijuí
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Sao Jose Do Rio Preto
country: Brazil
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Toronto
country: Canada
facility: Research Site
state: CA
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Santiago
country: Chile
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Holargos, Athens
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Fukushima-shi
country: Japan
facility: Research Site
city: Isehara-shi
country: Japan
facility: Research Site
city: Izumi-shi
country: Japan
facility: Research Site
city: Kishiwada-shi
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Nagaoka-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Natori-shi
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Saga-shi
country: Japan
facility: Research Site
city: Suita-shi
country: Japan
facility: Research Site
city: Sunto-gun
country: Japan
facility: Research Site
city: Tokushima-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Research Site
city: Seo-Gu
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: pos.Pesochnyi
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Marbella
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Bellinzona
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: New Taipei
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Songkhla
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Chernivtsі
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kirovohrad
country: Ukraine
facility: Research Site
city: Kryvyi Rih
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jared Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: