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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02118337




Registration number
NCT02118337
Ethics application status
Date submitted
11/04/2014
Date registered
21/04/2014

Titles & IDs
Public title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies
Scientific title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies
Secondary ID [1] 0 0
D6020C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Select Advanced Malignancies 0 0
Kidney Cancer 0 0
Clear Cell Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MEDI0680
Treatment: Other - Durvalumab
Treatment: Other - Nivolumab

Experimental: MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months.

Experimental: MEDI0680 0.1 mg/kg + Durvalumab 10 mg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Experimental: MEDI0680 0.5 mg/kg + Durvalumab 10 mg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Experimental: MEDI0680 2.5 mg/kg + Durvalumab 10 mg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Experimental: MEDI0680 10 mg/kg + Durvalumab 10 mg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Experimental: MEDI0680 20 mg/kg + Durvalumab 10 mg - Participants in dose-escalation phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months.

Experimental: MEDI0680 20 mg/kg - Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.

Experimental: MEDI0680 20 mg/kg + Durvalumab 750 mg - Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.

Active comparator: Nivolumab 240 mg - Participants in dose-expansion phase will receive IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first.


Treatment: Other: MEDI0680
Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase.

Treatment: Other: Durvalumab
Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.

Treatment: Other: Nivolumab
Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase
Timepoint [1] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Primary outcome [2] 0 0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase
Timepoint [2] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Primary outcome [3] 0 0
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase
Timepoint [3] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Primary outcome [4] 0 0
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase
Timepoint [4] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Primary outcome [5] 0 0
Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase
Timepoint [5] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [1] 0 0
Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
Timepoint [1] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [2] 0 0
Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
Timepoint [2] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [3] 0 0
Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
Timepoint [3] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [4] 0 0
Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
Timepoint [4] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [5] 0 0
Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
Timepoint [5] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [6] 0 0
Overall Survival in Dose-expansion Phase
Timepoint [6] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [7] 0 0
BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [7] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [8] 0 0
ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [8] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [9] 0 0
DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [9] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [10] 0 0
TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [10] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [11] 0 0
DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [11] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [12] 0 0
PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
Timepoint [12] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [13] 0 0
OS in Dose-escalation Phase
Timepoint [13] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
Secondary outcome [14] 0 0
Number of Participants With TEAEs and TESAEs in Dose-expansion Phase
Timepoint [14] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Secondary outcome [15] 0 0
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase
Timepoint [15] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Secondary outcome [16] 0 0
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase
Timepoint [16] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Secondary outcome [17] 0 0
Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase
Timepoint [17] 0 0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
Secondary outcome [18] 0 0
Antitumor Activity of MEDI0680 and Durvalumab Versus Nivolumab Monotherapy in Immunotherapy-Naïve Participants With Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC) Based on Blinded Independent Central Review (BICR) in Dose-expansion Phase
Timepoint [18] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
Secondary outcome [19] 0 0
Percent Change From Baseline in Tumor Size in Dose-escalation Phase (Based on Investigator-assessed Modified RECIST v1.1) and Dose-expansion Phase (Based on Investigator-assessed RECIST v1.1)
Timepoint [19] 0 0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant for dose-escalation phase and approximately 5 years 10 months for dose-expansion phase)
Secondary outcome [20] 0 0
Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases
Timepoint [20] 0 0
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
Secondary outcome [21] 0 0
Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases
Timepoint [21] 0 0
Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
Secondary outcome [22] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases
Timepoint [22] 0 0
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
Secondary outcome [23] 0 0
Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases
Timepoint [23] 0 0
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
Secondary outcome [24] 0 0
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase
Timepoint [24] 0 0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)

Eligibility
Key inclusion criteria
* Must be 18 years or older
* Eastern Cooperative Oncology Group performance status of 0-1
* Adequate organ function
* At least 1 prior line of therapy
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
* Prior treatment with immunotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2020
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Bentleigh
Recruitment hospital [2] 0 0
Research Site - Frankston
Recruitment postcode(s) [1] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Dijon
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 15
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Netherlands
State/province [21] 0 0
Amsterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Groningen
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridge
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Cardiff
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura Chow, MD
Address 0 0
University of Washington
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02118337