Advanced Solid TumorsPhase 1NCT02261220
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
A Phase 1 study testing MEDI4736 and tremelimumab in people with Advanced Solid Tumors, run by MedImmune LLC at 75 sites in 9 countries.
Trial summary
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MEDI4736 and tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 75 sitesin 9 countries
- Study dates
- 13 Oct 2014to 27 Jan 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects
- 18 years and older
- Histologic confirmation of advanced solid tumors
- Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Who cannot join
- Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
- Active or prior documented autoimmune disease within the past 2 years
- Current or prior use of immunosuppressive medication within 14 days with some exceptions.
Trial locations and contacts
75 sites in 9 countries.
75 sites in 9 countries
United States30 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Aurora, Colorado, 80045
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45219
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75230
Research Site
Duarte, California, 91010
Research Site
Fairfax, Virginia, 22031
Research Site
Greenville, South Carolina, 29605
Research Site
Houston, Texas, 77521
Research Site
Iowa City, Iowa, 52242-1008
Research Site
La Jolla, California, 92093
Research Site
Los Angeles, California, 90025
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Miami Beach, Florida, 33140
Research Site
New Haven, Connecticut, 06510
Research Site
New York, New York, 10065
Research Site
New York, New York, 10116
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Portland, Oregon, 97213
Research Site
Portland, Oregon, 97239
Research Site
San Antonio, Texas, 78229
Research Site
Scottsdale, Arizona, 85258
Research Site
Seattle, Washington, 98104
Research Site
Tampa, Florida, 33612
Research Site
The Bronx, New York, 10461
Research Site
Whittier, California, 90603
France9 sites
Research Site
Angers, 49055
Research Site
Besançon, 25030
Research Site
Bordeaux, 33075
Research Site
Lyon, 69008
Research Site
Marseille, 13005
Research Site
Montpellier, 34298
Research Site
Pierre-Bénite, 69495
Research Site
Vandœuvre-lès-Nancy, 54519
Research Site
Villejuif, 94805
South Korea8 sites
Research Site
Busan, 49241
Research Site
Daegu, 41404
Research Site
Daegu, 42601
Research Site
Gwangju, 61469
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03722
Research Site
Seoul, 06591
Research Site
Seoul, 135-710
Spain7 sites
Research Site
Barcelona, 08026
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Pamplona, 31008
Research Site
Valencia, 46010
United Kingdom6 sites
Research Site
Glasgow, G12 0YN
Research Site
London, EC1M 6BQ
Research Site
London, NW1 2BU
Research Site
Metropolitan Borough of Wirral, CH63 4JY
Research Site
Middlesbrough, TS4 3BW
Research Site
Oxford, OX3 7LE
Canada5 sites
Research Site
London, Ontario, N6A 4L6
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Québec, Quebec, G1R 2J6
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 1X5
Israel4 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 91031
Research Site
Kfar Saba, 44410
Research Site
Tel Aviv, 64239
Germany3 sites
Research Site
Jena, 07747
Research Site
Münster, 48149
Research Site
Tübingen, 72076
Netherlands3 sites
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV
Research Site
Tilburg, 5042AD
About this study
Official title: A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- MEDI4736, tremelimumab
- Keywords
- advanced solid tumors, durvalumab, tremelimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI4736Biological
MEDI4736 is administered by IV infusion in combination with tremelimumab
tremelimumabBiological
Tremelimumab is administered by IV infusion in combination with MEDI4736
| Study group | Role | What they receive |
|---|---|---|
| MEDI4736 + Tremelimumab | Experimental | Subjects with multiple tumor types. Receives: Biological: MEDI4736; Biological: tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting adverse events
Measured: Screening through 15 months after the last subject enters re-treatment
Number of subjects reporting serious adverse events
Measured: Screening through 15 months after the last subject enters re-treatment
Number of subjects experiencing a dose-limiting toxicity
Measured: First dose of study medication through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
Measured: Screening through 3 months after the last dose of study medication
Change from Baseline in vital signs
Measured: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiogram evaluations
Measured: Screening through 3 months after the last dose of study medication
Overall Response Rate in Select Tumor Types
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Secondary outcomes (11)
Overall Response Rate
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Disease Control Rate
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Duration of Response
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Progression-Free Survival
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Overall Survival
Measured: First dose of study medication through 15 months after the last subject enters re-treatment
Individual MEDI4736 concentrations
Measured: First dose of MEDI4736 through 3 months after the last dose of study medication
Individual tremelimumab concentrations
Measured: First dose of tremelimumab through 3 months after the last dose of study medication
MEDI4736 area under the concentration-curve
Measured: First dose of MEDI4736 through 3 months after the last dose of study medication
Tremelimumab area under the concentration-curve
Measured: First dose of tremelimumab through 3 months after the last dose of study medication
Number of subjects that develop detectable antidrug antibodies to MEDI4736
Measured: First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop antidrug antibodies to tremelimumab
Measured: First dose of tremelimumab through 3 months after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start13 Oct 2014
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MedImmune LLC, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261220
- Sponsor's protocol ID
- D4190C00010
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2014
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.
PubMed 32816849
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02261220
- Acronym / sponsor ID
- D4190C00010
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors, durvalumab, tremelimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 10 Oct 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.
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDI4736 + Tremelimumab | Experimental | Biological: MEDI4736, Biological: tremelimumabSubjects with multiple tumor types. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects
- 18 years and older
- Histologic confirmation of advanced solid tumors
- Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Key exclusion criteria (3 listed)
- Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
- Active or prior documented autoimmune disease within the past 2 years
- Current or prior use of immunosuppressive medication within 14 days with some exceptions.
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 |
|---|---|---|
| MEDI4736MEDI4736 is administered by IV infusion in combination with tremelimumab | Biological | MEDI4736 + Tremelimumab |
| tremelimumabTremelimumab is administered by IV infusion in combination with MEDI4736 | Biological | MEDI4736 + Tremelimumab |
Primary outcome
Number of subjects reporting adverse events
Time frame: Screening through 15 months after the last subject enters re-treatment
Number of subjects reporting serious adverse events
Time frame: Screening through 15 months after the last subject enters re-treatment
Number of subjects experiencing a dose-limiting toxicity
Time frame: First dose of study medication through 4 weeks after the first dose of study medication
Change from Baseline in laboratory evaluations
Time frame: Screening through 3 months after the last dose of study medication
Change from Baseline in vital signs
Time frame: Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiogram evaluations
Time frame: Screening through 3 months after the last dose of study medication
Overall Response Rate in Select Tumor Types
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
11 secondary outcomes
Overall Response Rate
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Disease Control Rate
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Duration of Response
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Progression-Free Survival
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Overall Survival
Time frame: First dose of study medication through 15 months after the last subject enters re-treatment
Individual MEDI4736 concentrations
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Individual tremelimumab concentrations
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication
MEDI4736 area under the concentration-curve
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Tremelimumab area under the concentration-curve
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication
Number of subjects that develop detectable antidrug antibodies to MEDI4736
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop antidrug antibodies to tremelimumab
Time frame: First dose of tremelimumab through 3 months after the last dose of study medication
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 6 Mar 2020.
- Derived from this study: PubMed 32816849Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.
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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
MedImmune LLC
75 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI4736 and tremelimumab in people with Advanced Solid Tumors, run by MedImmune LLC at 75 sites in 9 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 4 inclusion and 3 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, France, South Korea, Spain, United Kingdom and 4 more countries. 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 subjects reporting adverse events (time frame: Screening through 15 months after the last subject enters re-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?
On the ClinicalTrials.gov record for NCT02261220, 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 6 Mar 2020.