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EUCTR2016-005068-33

This is an open-label, multi-center, study to determine the short and long term safety of fixed doses of durvalumab 1500 mg + tremelimumab 75 mg combination therapy or durvalumab 1500 mg monotherapy in patients with advanced solid malignancies

Datenbasis: WHO (Import vom 15.04.2018)
Geändert: 15.04.2018
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

The target patient population of the protocol includes patients with advanced solid tumors who meet the overall and tumor specific inclusion and exclusion criteria as outlined in each protocol Module.Please refer to the protocol version and the tumor specific protocol Modules for the full list of medical conditions to be investigated.
MedDRA version: 20.0Level: PTClassification code 10061272Term: Malignant urinary tract neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04]

Interventions (Datenquelle: WHO)


Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DURVALUMAB
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Product Name: Tremelimumab
Product Code: MEDI1123
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tremelimumab
CAS Number: 745013-59-6
Current Sponsor code: MEDI1123
Other descriptive name: TREMELIMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
-Must have a life expectancy of at least 12 weeks
- Disease not amendable to curative surgery
- Eastern Cooperative Oncology Group (ECOG) performance status as defined in the specific module.
- Body weight >30 kg.
- No prior exposure to anti-PD-1or anti-PD-L1, including on another AstraZeneca study. Exposure to other investigational agents may be permitted after discussion with the Sponsor.
- Adequate organ and marrow function as defined in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion criteria:
- Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Local treatment of isolated lesions for palliative intent is acceptable (e.g., local surgery or radiotherapy).
- Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Note: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

- History of another primary malignancy except for
-- Malignancy treated with curative intent and with no known active disease =5 years before the first dose of investigational product (durvalumab + tremelimumab) and of low potential risk for recurrence
-- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
-- Adequately treated carcinoma in situ without evidence of disease

- History of leptomeningeal carcinomatosis
- Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on baseline brain imaging (please refer to RECIST for details on the imaging modality) obtained during the screening period or identified prior to signing the ICF. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least 4 weeks apart and show no evidence of intracranial progression). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of =10mg/day of prednisone or its equivalent and anti-convulsants for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline.
- History of active primary immunodeficiency.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tubercolosis testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients po

Weitere Angaben zur Studie im WHO-Primärregister

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-005068-33

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-005068-33

Weitere Informationen zur Studie

Registrationsdatum der Studie

24.05.2017

Einschluss der ersten teilnehmenden Person

28.08.2017

Rekrutierungsstatus

Authorised-recruitment may be ongoing or finished

Wissenschaftlicher Titel (Datenquelle: WHO)

An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies - STRONG

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immunerelatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and tremelimumab combination therapy or durvalumab monotherapy, using fixed dosing.
;Secondary Objective: 1. To assess the incidence, severity, nature, seriousness,
intervention/treatment, outcome, and causality of AEs (including SAEs).
2. To assess the incidence and frequency of durvalumab and
tremelimumab (as applicable to each tumor Module) interruption and
discontinuation due to treatment-emergent AEs (including SAEs).
3. To assess overall survival (OS).
;Primary end point(s): AESI outcome measures will be assessed, in order to further characterize safety objectives related to AESIs.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): SAE: Number and proportion of patients with SAEs in total and by causality and severity AEs leading to death: Number and proportion of patients with AEs leading to death
AEs leading to treatment interruption or discontinuation: Number and proportion of patients with AEs leading to treatment interruption and/or discontinuation
Overall Survival: defined as the time from the first date of treatment until death due to any cause. OS (days) = Death date or Censor date – treatment start date + 1. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
Objective Response Rate (ORR) and Disease Control Rate (DCR): based on investigator assessed response to treatment of CR and PR or CR, PR and SD respectively based on RECIST 1.1.;Timepoint(s) of evaluation of this end point: - at each visit (every 4 weeks) + safety-follow up visit (90 days after last dose)
- survival follow up (every 3 month for up to 5 years)

Kontakt für Auskünfte (Datenquelle: WHO)

AstraZeneca AB

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Austria, Canada, China, Denmark, Finland, France, Germany, Israel, Italy, Japan, Korea, Netherlands, Norway, Republic of, Spain, Sweden, Switzerland, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Clinical Trial Transparency
Forskargatan 18
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Clinical Trial Transparency
Forskargatan 18
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

AstraZeneca AB

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

D4191C00068;NCT03084471