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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
Date last updated
1/06/2021

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
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.
Trial website
https://clinicaltrials.gov/study/NCT02118337
Trial related presentations / publications
Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02118337