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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03530397




Registration number
NCT03530397
Ethics application status
Date submitted
28/03/2018
Date registered
21/05/2018

Titles & IDs
Public title
A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
Scientific title
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.
Secondary ID [1] 0 0
2018-003075-35
Secondary ID [2] 0 0
D7980C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Selected Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MEDI5752
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Other - Pembrolizumab
Treatment: Drugs - Paclitaxel or Nab-Paclitaxel

Experimental: Arm A: MEDI5752 - MEDI5752

Experimental: Arm B: MEDI5752 and chemotherapy - MEDI5752, pemetrexed, carboplatin and paclitaxel.

Active comparator: Arm C: Pembrolizumab and chemotherapy - pembrolizumab, pemetrexed, and carboplatin


Treatment: Other: MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.

Treatment: Drugs: Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation

Treatment: Drugs: Carboplatin
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation

Treatment: Other: Pembrolizumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation

Treatment: Drugs: Paclitaxel or Nab-Paclitaxel
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase)
Timepoint [1] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Primary outcome [2] 0 0
Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase)
Timepoint [2] 0 0
From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first
Primary outcome [3] 0 0
The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase)
Timepoint [3] 0 0
Up to 21 days following the first dose
Primary outcome [4] 0 0
The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase)
Timepoint [4] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Primary outcome [5] 0 0
The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase)
Timepoint [5] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Primary outcome [6] 0 0
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase)
Timepoint [6] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Primary outcome [7] 0 0
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase)
Timepoint [7] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Secondary outcome [1] 0 0
Pharmacokinetics of MEDI5752: Cmax
Timepoint [1] 0 0
To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
Secondary outcome [2] 0 0
Pharmacokinetics of MEDI5752: AUC
Timepoint [2] 0 0
To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
Secondary outcome [3] 0 0
Pharmacokinetics of MEDI5752: Clearance
Timepoint [3] 0 0
To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment
Secondary outcome [4] 0 0
Pharmacokinetics of MEDI5752: t 1/2
Timepoint [4] 0 0
To be assessed at Day 1, 2, 3, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.
Secondary outcome [5] 0 0
Ability of MEDI5752 to generate immune response in subjects with advanced solid tumors
Timepoint [5] 0 0
To be assessed at Day 1, 8, 15, 22, 29, 43, 64, 85, and 106 over the first 4 months of treatment and up to 114 days following end of treatment.
Secondary outcome [6] 0 0
PD-L1 Expression in subjects with advanced solid tumors
Timepoint [6] 0 0
To be assessed at baseline
Secondary outcome [7] 0 0
Preliminary Antitumor Activity: Duration of Response
Timepoint [7] 0 0
From the date of response through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Secondary outcome [8] 0 0
Preliminary Antitumor Activity: Disease Control
Timepoint [8] 0 0
From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Secondary outcome [9] 0 0
Preliminary Antitumor Activity: Progression Free Survival
Timepoint [9] 0 0
From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Secondary outcome [10] 0 0
Preliminary Antitumor Activity: Overall Survival
Timepoint [10] 0 0
From the first dose of study drug through the end of study, or date of death, or two years after last subject starts treatment whichever should occur first
Secondary outcome [11] 0 0
The number of subjects experiencing treatment related adverse events (AEs) (Dose-expansion phase)
Timepoint [11] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Secondary outcome [12] 0 0
The number of subjects experiencing abnormal laboratory evaluations (Dose-expansion phase)
Timepoint [12] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Secondary outcome [13] 0 0
The number of subjects experiencing Changes from baseline in vital signs reported as adverse events (Dose-expansion phase)
Timepoint [13] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product
Secondary outcome [14] 0 0
The number of subjects experiencing abnormal ECGs reported as adverse events (Dose-expansion phase)
Timepoint [14] 0 0
From the time of informed consent through 14 days following termination of treatment with investigational product
Secondary outcome [15] 0 0
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-expansion phase)
Timepoint [15] 0 0
From the time of informed consent through 114 days following termination of treatment with investigational product

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Age = 18 years at the time of screening
2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
3. Life expectancy = 12 weeks
4. Histologically or cytologically-confirmed advanced solid tumors
5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
8. Subjects must have at least one measurable lesion
9. Adequate organ and marrow function
10. Written informed consent and any locally required authorization
11. Subjects must provide tumor material as applicable
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site)
2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:

1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
6. Active or prior documented autoimmune or inflammatory disorders
7. History of active primary immunodeficiency:
8. History of organ transplant
9. Known allergy or reaction to any component of the planned study treatment.
10. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria
12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
14. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
15. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
16. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment hospital [2] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
France
State/province [7] 0 0
Bordeaux Cedex
Country [8] 0 0
France
State/province [8] 0 0
Lyon
Country [9] 0 0
France
State/province [9] 0 0
Villejuif Cedex
Country [10] 0 0
Italy
State/province [10] 0 0
Meldola
Country [11] 0 0
Italy
State/province [11] 0 0
Napoli
Country [12] 0 0
Italy
State/province [12] 0 0
Ravenna
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Cheongju-si
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Gyeonggi-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Incheon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Portugal
State/province [20] 0 0
Porto
Country [21] 0 0
Spain
State/province [21] 0 0
A Coruna
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Majadahonda
Country [24] 0 0
Spain
State/province [24] 0 0
Malaga
Country [25] 0 0
Spain
State/province [25] 0 0
Pamplona
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taichung
Country [28] 0 0
Taiwan
State/province [28] 0 0
Tainan
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei

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
Deepa Subramaniam, MD, MSc
Address 0 0
AstraZeneca
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.
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03530397