Select Advanced Solid TumorsPhase 1NCT02705482
A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
A Phase 1 study testing MEDI0562, Tremelimumab and Durvalumab in people with Select Advanced Solid Tumors, run by MedImmune LLC at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Select Advanced Solid Tumors
- What is being tested?
- MEDI0562, Tremelimumab and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 30 Mar 2016to 7 Aug 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria:
- Written and signed informed consent.
- Age ≥ 18 years at the time of study entry.
- Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
- Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
- Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid tumors according to treatment arm as specified in the protocol.
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- Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if additional protocol criteria are met.
- Subjects must have at least 1 lesion that is measurable using RECIST guidelines.
- Subjects must consent to provide archived tumor specimens for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
- All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies.
- ECOG Performance score of 0 or 1, unless protocol exceptions are met.
- In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
- Adequate hematologic, renal and hepatic function as determined by blood laboratory values.
- At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:
- No concurrent treatment, inclusive of, but not limited to surgery, radiation, and/or corticosteroids
- At least 42 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or computed tomography (CT) after last day of treatment
- At least 14 days since last dose of corticosteroids Note: Subjects with leptomeningeal disease or cord compression are excluded from the study.
- Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product.
- Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use male condom plus, if locally available, spermicide from Day 1 and for 180 days after receipt of the final dose of investigational product.
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- Prior treatment with TNFRSF agonists
- Prior treatment with IMT for certain disease types may be restricted per protocol.
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
- Active or prior documented autoimmune disease within the past 2 years.
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study
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- Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose
- Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior anticancer therapy.
- Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562 with exceptions as per protocol.
- History of primary immunodeficiency, solid organ transplantation, or tuberculosis
- Test results indicating active infection with human immunodeficiency virus (HIV) or hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic acid testing
- Pregnant or breastfeeding women
- Major surgery within 4 weeks prior to first dose of MEDI0562 or still recovering from prior surgery.
- Other invasive malignancy within 2 years with the exception of protocol specified criteria
- Any uncontrolled intercurent illness or condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Research Site
Albuquerque, New Mexico, 87106
Research Site
Chicago, Illinois, 60611
Research Site
Houston, Texas, 77030
Research Site
Huntersville, North Carolina, 28078
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10032
Research Site
Portland, Oregon, 97213
Research Site
Santa Monica, California, 90404
Research Site
St Louis, Missouri, 63110
Netherlands2 sites
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV
About this study
Official title: A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
Read the detailed description
This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
- Conditions
- Select Advanced Solid Tumors
- Being tested
- MEDI0562, Tremelimumab, Durvalumab
- Keywords
- Advanced solid tumors, MEDI0562, durvalumab, tremelimumab, OX40, PD-L1, CTLA-4, immuno-oncology, Cancer
- Medical subject headings
- Diabetes Mellitus, Insulin-Dependent, 12, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0562Biological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
TremelimumabBiological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
DurvalumabBiological
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: MEDI0562 and durvalumab | Experimental | MEDI0562 and durvalumab Receives: Biological: MEDI0562; Biological: Durvalumab |
| Arm B: MEDI0562 and tremelimumab | Experimental | MEDI0562 and tremelimumab Receives: Biological: MEDI0562; Biological: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
Measured: From time of informed consent through 12 weeks after ending treatment with investigational product
Secondary outcomes (14)
Preliminary Antitumor Activity:Best Overall Response
The endpoints for assessment of antitumor activity include Best Overall Response (BOR) and will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Measured: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include, but are not limited to, maximum observed concentration (Cmax).
Measured: To be assessed at approximately 12 clinic visits through Day 113
Immunogenicity
The endpoints for assessment of immunogenicity of MEDI0562, durvalumab, and tremelimumab include the number and percentage of subjects who develop detectable anti drug antibodies (ADAs).
Measured: At approximately 8 time points through Day 113.
Pharmacodynamic Activity
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphocyte populations and assessment of tumor-infiltrating lymphocytes (TILs) in tumor biopsy specimens.
Measured: At approximately 12 time points through Day 113.
Preliminary Antitumor Activity: Disease Control
The endpoints for assessment of antitumor activity include disease control and is defined as CR, PR, or SD according to RECIST v1.1
Measured: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Duration of Response
The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the first documentation of OR to the first documentation of disease progression or death due to any cause.
Measured: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Progression-free Survival
The endpoints for assessment of antitumor activity include progression-free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause
Measured: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Overall Survival
The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the time from the start of treatment with Investigational Product until death due to any cause.
Measured: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: AUC
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include area under the concentration-time curve (AUC).
Measured: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Clearance
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include clearance (CL).
Measured: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: t½
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include terminal phase half-life (t½).
Measured: To be assessed at approximately 12 clinic visits through Day 113
Preliminary Antitumor Activity: Objective Response
The endpoints for assessment of antitumor activity include objective response (OR) and is defined as confirmed CR or confirmed PR based on RECIST v1.1
Measured: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Time to Response
The endpoints for assessment of Time to Response TTR and is defined as the time of first treatment to a subsequently confirmed CR or confirmed PR based on RECIST v1.1
Measured: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Percent Change from Baseline
The endpoints for assessment percent change from baseline in target lesion sum of diameters will be calculated at each adequate post baseline disease assessment with recorded measurement for all target lesions defined at baseline.
Measured: At approximately 3 time points through Day 113.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start30 Mar 2016
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Select 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705482
- Sponsor's protocol ID
- D6060C00002
- Status last verified
- Aug 2019
- First submitted
- 22 Sep 2015
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and Tolerability of MEDI0562, an OX40 Agonist mAb, in Combination with Durvalumab or Tremelimumab in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Sep 1;28(17):3709-3719. doi: 10.1158/1078-0432.CCR-21-3016.
PubMed 35699623
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02705482
- Acronym / sponsor ID
- D6060C00002
- Conditions
- Select Advanced Solid Tumors
- Keywords
- Advanced solid tumors, MEDI0562, durvalumab, tremelimumab, OX40, PD-L1, CTLA-4, immuno-oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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 MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
Detailed description
This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: MEDI0562 and durvalumab | Experimental | Biological: MEDI0562, Biological: DurvalumabMEDI0562 and durvalumab |
| Arm B: MEDI0562 and tremelimumab | Experimental | Biological: MEDI0562, Biological: TremelimumabMEDI0562 and tremelimumab |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written and signed informed consent.
- Age ≥ 18 years at the time of study entry.
- Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
- Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
- Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid tumors according to treatment arm as specified in the protocol.
Key exclusion criteria (17 listed)
- Prior treatment with TNFRSF agonists
- Prior treatment with IMT for certain disease types may be restricted per protocol.
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
- Active or prior documented autoimmune disease within the past 2 years.
- Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study
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 |
|---|---|---|
| MEDI0562Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. | Biological | Arm A: MEDI0562 and durvalumab, Arm B: MEDI0562 and tremelimumab |
| TremelimumabSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. | Biological | Arm B: MEDI0562 and tremelimumab |
| DurvalumabSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. | Biological | Arm A: MEDI0562 and durvalumab |
Primary outcome
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
Time frame: From time of informed consent through 12 weeks after ending treatment with investigational product
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
14 secondary outcomes
Preliminary Antitumor Activity:Best Overall Response
Time frame: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Immunogenicity
Time frame: At approximately 8 time points through Day 113.
Pharmacodynamic Activity
Time frame: At approximately 12 time points through Day 113.
Preliminary Antitumor Activity: Disease Control
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Duration of Response
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Progression-free Survival
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Overall Survival
Time frame: At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: AUC
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Clearance
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: t½
Time frame: To be assessed at approximately 12 clinic visits through Day 113
Preliminary Antitumor Activity: Objective Response
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Time to Response
Time frame: At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Percent Change from Baseline
Time frame: At approximately 3 time points through Day 113.
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 26 Aug 2019.
- Derived from this study: PubMed 35699623Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and Tolerability of MEDI0562, an OX40 Agonist mAb, in Combination with Durvalumab or Tremelimumab in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Sep 1;28(17):3709-3719. doi: 10.1158/1078-0432.CCR-21-3016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI0562, Tremelimumab and Durvalumab in people with Select Advanced Solid Tumors, run by MedImmune LLC at 12 sites in 3 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 19 inclusion and 17 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Netherlands, France. 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?
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT). (time frame: From time of informed consent through 12 weeks after ending treatment with investigational product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705482, which also lists 1 linked publication.
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 26 Aug 2019.