Advanced Solid TumorsPhase 1NCT03089645
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
A Phase 1 study testing MEDI5083 monotherapy, MEID5083 with Durvalumab or Tremelimumab and Medi5083 with Durvalumab and Docetaxel in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 101 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MEDI5083 monotherapy, MEID5083 with Durvalumab or Tremelimumab and Medi5083 with Durvalumab and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 21 Mar 2017to 23 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of screening or age of consent according to local law
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically confirmed metastatic or recurrent tumor types
- Subjects who have received prior immunotherapy may be eligible
- Subjects must have at least one measurable lesion
- Consent to provide archival tumor tissue and pre/on-treatment biopsies
- Adequate organ and marrow function
- Consent to use one highly effective method of contraception
Who cannot join
- Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
- Concurrent enrollment in another clinical study
- Active/prior autoimmune of inflammatory disorders
- History of immunodeficiency, solid organ transplant, or tuberculosis
- Known allergy/hypersensitivity to drug or components
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Research Site
Hackensack, New Jersey, 07601-2191
Research Site
Nashville, Tennessee, 37203
Research Site
Providence, Rhode Island, 02903
Research Site
Salt Lake City, Utah, 84112
Australia4 sites
Research Site
Clayton, 3168
Research Site
Melbourne, 3000
Research Site
Melbourne, 3004
Research Site
Randwick, 2031
About this study
Official title: A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.
Read the detailed description
This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI5083 monotherapy, MEID5083 with Durvalumab or Tremelimumab, Medi5083 with Durvalumab and Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI5083 monotherapyBiological
Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab
MEID5083 with Durvalumab or TremelimumabBiological
Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab
Medi5083 with Durvalumab and DocetaxelBiological
Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors Receives: Biological: MEDI5083 monotherapy |
| Part 2 | Experimental | Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors. Receives: Biological: MEID5083 with Durvalumab or Tremelimumab |
| Part 3 | Experimental | Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC Receives: Biological: Medi5083 with Durvalumab and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) as a measure of safety
Safety Endpoint
Measured: From the time of consent through 120 days after last treatment
Number of participants with Serious Adverse Events (SAEs) as a measure of safety
Safety Endpoint
Measured: From the time of consent through 120 days after last treatment
Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety
Safety Endpoint
Measured: From the time of first dose through 28 days thereafter
The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose
Safety Endpoint
Measured: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Discontinuation of investigational products due to toxicity
Safety Endpoint
Measured: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.
Safety Endpoint
Measured: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Antitumor activity endpoints OR, based on RECIST v1.1
Safety Endpoint
Measured: Part 3
Secondary outcomes (14)
Serum MEDI5083 concentration levels
Pharmacokinetics (PK)
Measured: From the time of first dose through 57 days after first treatment
Reduction in peripheral blood CD19+ B cells
Pharmacodynamics (PD)
Measured: From the time of first dose through 57 days after first treatment
Incidence of anti-drug antibody (ADA) responses to MEDI5083
Immunogenicity
Measured: From the time of first dose through 2 years after last treatment
Objective Response Rate (ORR)
Clinical Activity Endpoint
Measured: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Progression Free Survival (PFS) at 6 months (PFS-6)
Clinical Activity Endpoint
Measured: From the time of first dose until 6 months after the last subject is dosed
Overall Survival (OS)
Clinical Activity Endpoint
Measured: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Disease Control Rate (DCR)
Clinical Activity Endpoint
Measured: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Duration of Response (DoR)
Clinical Activity Endpoint
Measured: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Serum Durvalumab concentration levels collected over time
Pharmacokinetics (PK)
Measured: From the time of first dose through 29 days after first treatment
Incidence of anti-drug antibody (ADA) responses to Durvalumab
Immunogenicity
Measured: From the time of first dose through 2 years after last treatment
Incidence of anti-drug antibody (ADA) responses to tremelilumab
Immunogenicity
Measured: From the time of first dose through 2 years after last treatment
Serum tremelimumab concentration levels collected over time
Pharmacodynamics (PD)
Measured: From the time of first dose through 57 days after first treatment
PD of MEDI5083 alone and in combination with Durvalumab and tremelimumab
Pharmacodynamics (PD)
Measured: From the time of first dose through 57 days after first treatment
Safety and tolerability of MEDI5083 with durvalumamb and docetaxel and in subjects with IO relapsed/refractory 2/3L NSCLC
Safety
Measured: From the time of first dose through 57 days after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start21 Mar 2017
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MedImmune LLC, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089645
- Sponsor's protocol ID
- D6840C00001
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03089645
- Acronym / sponsor ID
- D6840C00001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.
Detailed description
This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Biological: MEDI5083 monotherapyMEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors |
| Part 2 | Experimental | Biological: MEID5083 with Durvalumab or TremelimumabSequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors. |
| Part 3 | Experimental | Biological: Medi5083 with Durvalumab and DocetaxelMedi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years at the time of screening or age of consent according to local law
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically or cytologically confirmed metastatic or recurrent tumor types
- Subjects who have received prior immunotherapy may be eligible
- Subjects must have at least one measurable lesion
Key exclusion criteria (7 listed)
- Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
- Concurrent enrollment in another clinical study
- Active/prior autoimmune of inflammatory disorders
- History of immunodeficiency, solid organ transplant, or tuberculosis
- Known allergy/hypersensitivity to drug or components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI5083 monotherapyDose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab | Biological | Part 1 |
| MEID5083 with Durvalumab or TremelimumabSequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab | Biological | Part 2 |
| Medi5083 with Durvalumab and DocetaxelMedi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel | Biological | Part 3 |
Primary outcome
Number of participants with Adverse Events (AEs) as a measure of safety
Time frame: From the time of consent through 120 days after last treatment
Safety Endpoint
Number of participants with Serious Adverse Events (SAEs) as a measure of safety
Time frame: From the time of consent through 120 days after last treatment
Safety Endpoint
Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety
Time frame: From the time of first dose through 28 days thereafter
Safety Endpoint
The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose
Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Safety Endpoint
Discontinuation of investigational products due to toxicity
Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Safety Endpoint
Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.
Time frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Safety Endpoint
Antitumor activity endpoints OR, based on RECIST v1.1
Time frame: Part 3
Safety Endpoint
14 secondary outcomes
Serum MEDI5083 concentration levels
Time frame: From the time of first dose through 57 days after first treatment
Reduction in peripheral blood CD19+ B cells
Time frame: From the time of first dose through 57 days after first treatment
Incidence of anti-drug antibody (ADA) responses to MEDI5083
Time frame: From the time of first dose through 2 years after last treatment
Objective Response Rate (ORR)
Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Progression Free Survival (PFS) at 6 months (PFS-6)
Time frame: From the time of first dose until 6 months after the last subject is dosed
Overall Survival (OS)
Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Disease Control Rate (DCR)
Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Duration of Response (DoR)
Time frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Serum Durvalumab concentration levels collected over time
Time frame: From the time of first dose through 29 days after first treatment
Incidence of anti-drug antibody (ADA) responses to Durvalumab
Time frame: From the time of first dose through 2 years after last treatment
Incidence of anti-drug antibody (ADA) responses to tremelilumab
Time frame: From the time of first dose through 2 years after last treatment
Serum tremelimumab concentration levels collected over time
Time frame: From the time of first dose through 57 days after first treatment
PD of MEDI5083 alone and in combination with Durvalumab and tremelimumab
Time frame: From the time of first dose through 57 days after first treatment
Safety and tolerability of MEDI5083 with durvalumamb and docetaxel and in subjects with IO relapsed/refractory 2/3L NSCLC
Time frame: From the time of first dose through 57 days after first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MedImmune LLC study director
Sponsor GmbH
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI5083 monotherapy, MEID5083 with Durvalumab or Tremelimumab and Medi5083 with Durvalumab and Docetaxel in people with Advanced Solid Tumors, run by MedImmune LLC at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) as a measure of safety (time frame: From the time of consent through 120 days after last treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.