Recurrent or Metastatic Solid TumorsPhase 1NCT02221960
A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
A Phase 1 study testing MEDI6383 and MEDI6383 and MEDI4736 in people with Recurrent or Metastatic Solid Tumors, run by MedImmune LLC at 8 sites in 2 countries.
Trial summary
To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Recurrent or Metastatic Solid Tumors
- What is being tested?
- MEDI6383 and MEDI6383 and MEDI4736
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 15 Sep 2014to 3 Jul 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects; age ≥ 18
- Written informed consent must be obtained
- Subjects must meet the following criteria:
- Have recurrent or metastatic solid tumors
- 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 5 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies
- Subjects must have at least 1 lesion
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- Subjects must consent to provide archived tumor specimens and / or tumor biopsy for correlative biomarker studies.
- Eastern Cooperative Oncology Group performance score of 0 or 1
- In the opinion of the invesgator likely to complete ≥ 8 weeks of treatment.
- Adequate organ function as determined by:
- Absolute neutrophil count ≥ 1.5 x 109/L (1,500/mm3) ii.Platelet count ≥ 100 x 109/L (100,000/mm3) iii.Hemoglobin ≥ 9.0 g/dL within first 2 weeks prior to first dose of investigational product iv.Calculated creatinine clearance* (CrCl) or 24 hour urine CrCl > 50 mL/min v.Total bilirubin ≤ 1.5× ULN; for subjects with documented/suspected Gilbert's disease, bilirubin ≤ 3× ULN vi.Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5× ULN vii.Serum Electrolytes within normal limits
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 methods of highly effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product; 10) Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through 90 days after receipt of the final dose of investigational product
Who cannot join
- Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR) .
- Subjects who have received prior therapy with regimens containing CTLA-4, PDL-1, or PD-1 antagonists are NOT permitted to enroll unless all of the following apply:
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
- All AEs while receiving prior immunotherapy must have resolved to ≤ Grade 1 or baseline prior to screening for this study.
- Must not have experienced a ≥ Grade 3 AE or neurologic or ocular AE of any grade while receiving prior immunotherapy
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
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- Active or prior documented autoimmune disease within the past 2 years.
- Untreated central nervous system metastatic disease l
- Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study
- Receipt of anticancer therapy within 28 days prior to the first dose of Investigational Product
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior anticancer therapy
- Systemic 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 MEDI6383. )
- History of primary immunodeficiency, solid organ transplantation, or tuberculosis
- True positive test results for human immunodeficiency virus (HIV) or hepatitis B or C
- Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products )
- Pregnant or breastfeeding women
- Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI6383 or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable
- Other invasive malignancy within 2 years
- -
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Research Site
Chicago, Illinois, 60611
Research Site
La Jolla, California, 92093
Research Site
Nashville, Tennessee, 37203
Research Site
New Haven, Connecticut, 06520
Research Site
New York, New York, 10065
Research Site
Portland, Oregon, 97213
Research Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.
Read the detailed description
This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity of MEDI6383 alone and in combination with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.
- Conditions
- Recurrent or Metastatic Solid Tumors
- Being tested
- MEDI6383, MEDI6383 and MEDI4736
- Keywords
- Recurrent or metastatic solid tumors, MEDI6383, OX40
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI6383Biological
Subjects will receive MEDI6383 until disease progression or adverse event.
MEDI6383 and MEDI4736Biological
Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Arm | Experimental | MEDI6383 Receives: Biological: MEDI6383 |
| Combination Arm | Experimental | MEDI6383 and MEDI4736 Receives: Biological: MEDI6383 and MEDI4736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Primary endpoint will be the number (%) of subjects with adverse events and serious adverse events.
Measured: From time of informed consent through 12 weeks after last dose of investigational product
Secondary outcomes (4)
Preliminary Antitumor Activity
The endpoints for assessment of antitumor activity include objective response (OR), disease control (DC), duration of response (DoR), progression-free survival (PFS), and 3-year overall survival (OS)
Measured: Duration of Study
Pharmacokinetics of MEDI6383 or MEDI6383/MEDI4736
When MEDI6383 is administered alone, the endpoints for assessment of PK of MEDI6383 include individual subject MEDI6383 concentrations in serum at different time points after MEDI6383 administration. When MEDI6383 is administered together with MEDI4736, the endpoints for assessment of PK of MEDI6383 and MEDI4736 include individual subject MEDI6383 and MEDI4736 concentrations in serum at different time points after MEDI6383 and MEDI4736 administration. PK Parameters that may be modeled may include Cmax, Area Under the concentration-time curve, Clearance, and terminal half-live.
Measured: From time of informed consent through 12 weeks after last dose of investigational product
Biomarker Activity
The endpoints for assessment of pharmacodynamic activity include immunohistochemistry of tumor biopsies and assessment of tumor-infiltrating lymphocyte phenotypic markers
Measured: From time of informed consent through 12 weeks after last dose of investigational product
Immunogenicity
The endpoint for for the assessment of immunogenicity will include the number and percentage of subjects that develop anti-drug antibodies.
Measured: From time of informed consent through 12 weeks after last dose of investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study start15 Sep 2014
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medimmune Medimmune, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221960
- Sponsor's protocol ID
- D6050C00001
- Status last verified
- Mar 2019
- First submitted
- 19 Aug 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02221960
- Acronym / sponsor ID
- D6050C00001
- Conditions
- Recurrent or Metastatic Solid Tumors
- Keywords
- Recurrent or metastatic solid tumors, MEDI6383, OX40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 21 Aug 2014 (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.
To evaluate MEDI6383 when given alone or together with MEDI4736 in adult subjects with recurrent or metastatic solid tumors.
Detailed description
This is a Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity of MEDI6383 alone and in combination with MEDI4736 in adult subjects with recurrent or metastatic 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 |
|---|---|---|
| Monotherapy Arm | Experimental | Biological: MEDI6383MEDI6383 |
| Combination Arm | Experimental | Biological: MEDI6383 and MEDI4736MEDI6383 and MEDI4736 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female subjects; age ≥ 18
- Written informed consent must be obtained
- Subjects must meet the following criteria:
- Subjects must have at least 1 lesion
- Subjects must consent to provide archived tumor specimens and / or tumor biopsy for correlative biomarker studies.
Key exclusion criteria (21 listed)
- Prior treatment with TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR) .
- Subjects who have received prior therapy with regimens containing CTLA-4, PDL-1, or PD-1 antagonists are NOT permitted to enroll unless all of the following apply:
- Must not have experienced a ≥ Grade 3 AE or neurologic or ocular AE of any grade while receiving prior immunotherapy
- 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.
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 |
|---|---|---|
| MEDI6383Subjects will receive MEDI6383 until disease progression or adverse event. | Biological | Monotherapy Arm |
| MEDI6383 and MEDI4736Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event. | Biological | Combination Arm |
Primary outcome
Safety
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
Primary endpoint will be the number (%) of subjects with adverse events and serious adverse events.
4 secondary outcomes
Preliminary Antitumor Activity
Time frame: Duration of Study
Pharmacokinetics of MEDI6383 or MEDI6383/MEDI4736
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
Biomarker Activity
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
Immunogenicity
Time frame: From time of informed consent through 12 weeks after last dose of investigational product
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 13 Mar 2019.
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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 Medimmune study director
MedImmune LLC
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 MEDI6383 and MEDI6383 and MEDI4736 in people with Recurrent or Metastatic 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 12 inclusion and 21 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 13 Mar 2019. 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?
Safety (time frame: From time of informed consent through 12 weeks after last dose of investigational product). 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 13 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.