Squamous Cell Carcinoma of the Head and NeckPhase 1NCT02262741
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
A Phase 1 study testing MEDI4736 and tremelimumab in people with Squamous Cell Carcinoma of the Head and Neck, run by MedImmune LLC at 23 sites in 2 countries.
Trial summary
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- 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
- 71 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 15 Oct 2014to 21 Sep 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
- 18 years and older
- Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
- Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
- Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.
Who cannot join
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
- Concurrent or prior use of immunosuppressive medication within 14 days
- Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States21 sites
Research Site
Aurora, Colorado, 80045
Research Site
Baltimore, Maryland, 21287
Research Site
Chicago, Illinois, 60611
Research Site
Detroit, Michigan, 48201
Research Site
Fairfax, Virginia, 22031
Research Site
Fairway, Kansas, 66205
Research Site
Greenville, South Carolina, 29605
Research Site
La Jolla, California, 92093
Research Site
Los Angeles, California, 90025
Research Site
Los Angeles, California, 90095
Research Site
Minneapolis, Minnesota, 55455
Research Site
New Haven, Connecticut, 06520
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10016
Research Site
New York, New York, 10065
Research Site
Orlando, Florida, 32806
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Portland, Oregon, 97213
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94143
Research Site
Scottsdale, Arizona, 85258
Canada2 sites
Research Site
London, Ontario, N6A 4L6
Research Site
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
- Being tested
- MEDI4736, tremelimumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI4736Biological
MEDI4736 will be administered by IV infusion in combination with tremelimumab.
tremelimumabBiological
Tremelimumab will be administered by IV infusion in combination with MEDI4736.
| Study group | Role | What they receive |
|---|---|---|
| MEDI4736 + tremelimumab | Experimental | Not described 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 3 months after the last dose of study medication
Number of subjects reporting serious adverse events
Measured: Screening through 3 months after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
Measured: First dose of study medications 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 electrocardiograms
Measured: Screening through 3 months through last dose of study medication
Change from Baseline in vital signs
Measured: Screening through 3 months after the last dose of study medication
Secondary outcomes (11)
Objective Response Rate
Measured: Screening through 5 years after the last subject receives the first dose of study medication
Individual MEDI4736 concentrations
Measured: First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736
Measured: First dose of MEDI4736 through 6 months after the last dose of study medication
Disease Control Rate
Measured: Screening through 5 years after the last subject receives the first dose of study medication
Duration of Response
Measured: Screening through 5 years after the last subject receives the first dose of study medication
Progression Free Survival
Measured: Screening through 5 years after the last subject receives the first dose of study medication
Overall Survival
Measured: Screening through 5 years after the last subject receives the first 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 tremelimumb through 3 months after the last dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab
Measured: First dose of tremelimumab through 6 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 posted13 Oct 2014 (estimated)
- Study start15 Oct 2014
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
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 Squamous Cell Carcinoma of the Head and NeckStudies 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
- 71 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
- NCT02262741
- Sponsor's protocol ID
- D4190C00011
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2014
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Algazi A, Papadopoulos KP, Tsai F, Hansen AR, Angra N, Das M, Sheth S, Siu LL. Safety and clinical activity of durvalumab combined with tremelimumab in recurrent/metastatic head and neck squamous cell carcinoma: a multicenter phase I study. ESMO Open. 2024 Aug;9(8):103646. doi: 10.1016/j.esmoop.2024.103646. Epub 2024 Jul 23.
PubMed 39043009
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination With Tremelimumab in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02262741
- Acronym / sponsor ID
- D4190C00011
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 13 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, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.
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: tremelimumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects
- 18 years and older
- Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) that is incurable by local therapy.
- Subjects who are treatment-naive or pretreated (prior anti-PD-1 or anti-PD-L1 required) in the recurrent/metastatic setting.
- Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay.
Key exclusion criteria (3 listed)
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
- Concurrent or prior use of immunosuppressive medication within 14 days
- Active or prior documented autoimmune or inflammatory disease within 3 years 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 will be administered by IV infusion in combination with tremelimumab. | Biological | MEDI4736 + tremelimumab |
| tremelimumabTremelimumab will be administered by IV infusion in combination with MEDI4736. | Biological | MEDI4736 + tremelimumab |
Primary outcome
Number of subjects reporting adverse events
Time frame: Screening through 3 months after the last dose of study medication
Number of subjects reporting serious adverse events
Time frame: Screening through 3 months after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
Time frame: First dose of study medications 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 electrocardiograms
Time frame: Screening through 3 months through last dose of study medication
Change from Baseline in vital signs
Time frame: Screening through 3 months after the last dose of study medication
11 secondary outcomes
Objective Response Rate
Time frame: Screening through 5 years after the last subject receives the first dose of study medication
Individual MEDI4736 concentrations
Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to MEDI4736
Time frame: First dose of MEDI4736 through 6 months after the last dose of study medication
Disease Control Rate
Time frame: Screening through 5 years after the last subject receives the first dose of study medication
Duration of Response
Time frame: Screening through 5 years after the last subject receives the first dose of study medication
Progression Free Survival
Time frame: Screening through 5 years after the last subject receives the first dose of study medication
Overall Survival
Time frame: Screening through 5 years after the last subject receives the first 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 tremelimumb through 3 months after the last dose of study medication
Number of subjects that develop changes in detectable antidrug antibodies to tremelimumab
Time frame: First dose of tremelimumab through 6 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 23 Oct 2017.
- Derived from this study: PubMed 39043009Algazi A, Papadopoulos KP, Tsai F, Hansen AR, Angra N, Das M, Sheth S, Siu LL. Safety and clinical activity of durvalumab combined with tremelimumab in recurrent/metastatic head and neck squamous cell carcinoma: a multicenter phase I study. ESMO Open. 2024 Aug;9(8):103646. doi: 10.1016/j.esmoop.2024.103646. Epub 2024 Jul 23.
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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
23 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 MEDI4736 and tremelimumab in people with Squamous Cell Carcinoma of the Head and Neck, run by MedImmune LLC at 23 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 5 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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 3 months after the last dose of study medication). The study lists 6 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 NCT02262741, 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 23 Oct 2017.