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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02118337
Ethics application status
Date submitted
11/04/2014
Date registered
21/04/2014
Date last updated
14/04/2020

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 Subjects 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
Other interventions - MEDI0680
Other interventions - Durvalumab
Other interventions - Nivolumab

Experimental: 0.1 mg/kg MEDI0680 Q2W; 3 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab in combination

Active Comparator: Nivolumab - Nivolumab monotherapy at the selected dose

Experimental: 0.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab combination

Experimental: 0.1 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab in combination

Experimental: 2.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab in combination

Experimental: 10 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab in combination

Experimental: 20 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W - MEDI0680 and Durvalumab in combination

Experimental: 20 mg/kg MEDI0680 Q2W; 750 mg durvalumab Q2W - MEDI0680 and Durvalumab in combination


Other interventions: MEDI0680
anti-PD-1

Other interventions: Durvalumab
anti-PD-L1

Other interventions: Nivolumab
anti PD-1

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation: Number of subjects with adverse events - Assessed by number of subjects with AEs and SAEs
Timepoint [1] 0 0
From first dose of study drugs until 90 days after the last dose of study drugs
Primary outcome [2] 0 0
Dose Expansion: Antitumor activity - Determination of antitumor activity based on investigator assessed response using RECIST v1.1
Timepoint [2] 0 0
From first dose of study drug through study completion
Secondary outcome [1] 0 0
Dose Escalation: Antitumor activity of MEDI0680 in combination with MEDI4736 in subjects with select advanced malignancies - Determination of antitumor activity based on investigator assessed response using RECIST v1.1
Timepoint [1] 0 0
From first dose of study drugs through study completion
Secondary outcome [2] 0 0
Dose Expansion: Safety of MEDI0680 Monotherapy and in combination with MEDI4736 - To be assessed by number of subjects with AEs and SAEs
Timepoint [2] 0 0
From first dose through 90 days after last dose of study drugs
Secondary outcome [3] 0 0
Dose Expansion: Antitumor activity of MEDI0680 monotherapy and in combination with MEDI4736 - Determination of antitumor activity based on blinded independent central review assessed response using RECIST v1.1
Timepoint [3] 0 0
From the time of first dose through study completion
Secondary outcome [4] 0 0
Both Phases: Pharmacokinetics of MEDI0680 monotherapy and in combination with MEDI4736 and MEDI4736 in combination with MEDI0680 - Pharmacokinetics as measured by drug concentration in serum
Timepoint [4] 0 0
From first dose until 12 months after the last dose
Secondary outcome [5] 0 0
Both Phases: Immunogenicity of MEDI0680 and MEDI4736 - Immunogenicity as measured by presence of detectable ADAs
Timepoint [5] 0 0
From first dose of study drugs until 12 months after last dose of study drugs
Secondary outcome [6] 0 0
PD-L1 as a predictive biomarker - PD-L1 expression on the tumor membrane and tumor-infiltrating immune cells within the tumor microenvironment
Timepoint [6] 0 0
From first dose of study drug through study completion

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
Gender
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/Phase 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with
Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.
Trial website
https://clinicaltrials.gov/show/NCT02118337
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

Summary results
Other publications