Recurrent/Metastatic Squamous Cell Carcinoma of Head & NeckPhase 2NCT02319044
Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing MEDI4736, Tremelimumab and MEDI4736 + Tremelimumab in people with Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck, run by AstraZeneca at 125 sites in 15 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or… Read more about this study
- Who is it for?
- Ages 18 to 96 years
- Conditions the study is for
- Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck
- What is being tested?
- MEDI4736, Tremelimumab and MEDI4736 + Tremelimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 125 sitesin 15 countries
- Study dates
- 15 Apr 2015to 6 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 96 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Written informed consent obtained from the patient/legal representative;
- Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent; Patients who have only received chemo-radiation with curative intent for treatment of their locally advanced disease or recurrent disease are not eligible. Patients who received concurrent chemo-radiation as part of treatment of their recurrent disease are also not eligible.
- Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
- Confirmed PD-L1-negative SCCHN by Ventana SP263;
- WHO/ECOG performance status of 0 or 1;
Show all 9Show fewer
- At least 1 measurable lesion at baseline;
- No prior exposure to immune-mediated therapy;
- Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Who cannot join
- Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck;
- Received more than 1 regimen for recurrent or metastatic disease
- Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
- Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;
- Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment;
- Major surgical procedure within 28 days prior to the first dose of Investigational Product;
Show all 21Show fewer
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion;
- Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;
- History of allogeneic organ transplantation;
- Active or prior documented autoimmune or inflammatory disorders;
- Uncontrolled intercurrent illness;
- another primary malignancy
- Patients with history of brain metastases, spinal cord compression, or a history of leptomeningeal carcinomatosis;
- History of active primary immunodeficiency;
- Known history of previous tuberculosis;
- Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product;
- Pregnant or breast-feeding female patients;
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction
- Known allergy or hypersensitivity to Investigational Product.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of patient safety or study results
Trial locations and contacts
125 sites in 15 countries.
125 sites in 15 countries
United States43 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Arlington, Texas, 76012
Research Site
Atlanta, Georgia, 30322
Research Site
Augusta, Georgia, 30912
Research Site
Aurora, Colorado, 80045
Research Site
Austin, Texas, 78701
Research Site
Baltimore, Maryland, 21201
Research Site
Baltimore, Maryland, 21204
Research Site
Bethlehem, Pennsylvania, 18015
Research Site
Birmingham, Alabama, 35294
Research Site
Boston, Massachusetts, 02215
Research Site
Charleston, South Carolina, 29425
Research Site
Chicago, Illinois, 60637
Research Site
Dallas, Texas, 75230
Research Site
Detroit, Michigan, 48201
Research Site
Downey, California, 90241
Research Site
Duarte, California, 91010-3012
Research Site
Durham, North Carolina, 27705
Research Site
Evanston, Illinois, 60201
Research Site
Knoxville, Tennessee, 37909
Research Site
La Jolla, California, 92093
Research Site
Lebanon, New Hampshire, 03756
Research Site
Lexington, Kentucky, 40536-0001
Research Site
Little Rock, Arkansas, 72205
Research Site
Long Beach, California, 90813
Research Site
Los Angeles, California, 90033
Research Site
Los Angeles, California, 90095
Research Site
Macon, Georgia, 31201
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Morgantown, West Virginia, 26506
Research Site
Nashville, Tennessee, 37232
Research Site
New York, New York, 10032
Research Site
Pittsburgh, Pennsylvania, 15232
Research Site
Portland, Oregon, 97239
Research Site
Rochester, Minnesota, 55905-0001
Research Site
San Francisco, California, 94115
Research Site
Southfield, Michigan, 48075
Research Site
St Louis, Missouri, 63110
Research Site
Stony Brook, New York, 11794
Research Site
Tampa, Florida, 33612
Research Site
The Bronx, New York, 10467
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Yuma, Arizona, 85364
France16 sites
Research Site
Angers, 49933
Research Site
Bordeaux, 33604
Research Site
Brest, 29229
Research Site
Dijon, 21079
Research Site
Le Mans, 72000
Research Site
Lille, 59020
Research Site
Lorient, 56322
Research Site
Lyon, 69373
Research Site
Montpellier, 34298
Research Site
Nice, 6189
Research Site
Rouen, 76038
Research Site
Saint-Brieuc, 22015
Research Site
Saint-Grégoire, 35768
Research Site
Strasbourg, 67085
Research Site
Toulouse, 31059
Research Site
Villejuif, 94805
Spain15 sites
Research Site
Barakaldo, 48903
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Barcelona, 08907
Research Site
Girona, 17007
Research Site
Granada, 18014
Research Site
Jaén, 23007
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Madrid, 28050
Research Site
Málaga, 29010
Research Site
Marbella (Málaga), 29600
Research Site
Valencia, 46014
Research Site
Valencia, 46026
Research Site
Zaragoza, 50009
Hungary8 sites
Research Site
Budapest, 1077
Research Site
Budapest, 1083
Research Site
Budapest, 1122
Research Site
Győr, 9024
Research Site
Gyula, 5700
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3526
Research Site
Zalaegerszeg, 8900
Canada7 sites
Research Site
Calgary, Alberta, T2N 2T9
Research Site
London, Ontario, N6A 4L6
Research Site
Moncton, New Brunswick, E1C 6Z8
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Toronto, Ontario, M5G 2M9
Germany6 sites
Research Site
Berlin, 12203
Research Site
Halle, 06120
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Leipzig, 04103
Research Site
München, 81377
United Kingdom6 sites
Research Site
Aberdeen, AB25 2ZN
Research Site
Birmingham, B15 2TH
Research Site
Glasgow, G12 0YN
Research Site
London, E1 1BB
Research Site
Manchester, M20 4BX
Research Site
Metropolitan Borough of Wirral, CH63 4JY
Belgium5 sites
Research Site
Brussels, 1090
Research Site
Charleroi, 6000
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
Namur, 5000
Georgia5 sites
Research Site
Batumi, 6010
Research Site
Batumi, 6400
Research Site
Tbilisi, 0144
Research Site
Tbilisi, 0177
Research Site
Tbilisi, 0179
Australia3 sites
Research Site
Adelaide, 5000
Research Site
Darlinghurst, 2010
Research Site
Tweed Heads, 2485
Israel3 sites
Research Site
Haifa, 31096
Research Site
Petah Tikva, 4941492
Research Site
Tel HaShomer, 52621
South Korea3 sites
Research Site
Daegu, 42601
Research Site
Goyang-si, 10408
Research Site
Suwon, 16247
Malaysia2 sites
Research Site
Kuala Lumpur, 59100
Research Site
Kuching, 93586
About this study
Official title: A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.
Read the detailed description
This is a randomized, open-label, multi-center, global, Phase II study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and tremelimumab monotherapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease, that must have contained a platinum agent.
Patients will be randomized in a stratified manner according to prognostic factors, including human papillomavirus (HPV) status and smoking status to achieve a balance between treatments for each of the factors. Patients will be randomized in a 1:1:2 fashion to receive MEDI4736 monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination.
All treatments will be administered beginning on Day 0 for 12 months or until confirmed progression of disease; unless, in the Investigator's opinion, the patient continues to receive benefit from the treatment), initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Patients with confirmed progression of disease who, in the Investigator's opinion, continue to receive benefit from their assigned investigational product and who meet the criteria for treatment in the setting of progression of disease may continue to receive their assigned investigational product treatment for a maximum of 12 months after consultation with the Sponsor and at the Investigator's discretion. The monotherapy arms (tremelimumab and MEDI4736) should be discontinued if there is confirmed progression of disease following a previous response in target lesions (complete response or partial response).
Tumor assessments will be performed using computed tomography or magnetic resonance imaging. Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (q8w) for the first 48 weeks (relative to the date of the first infusion) then q12w in patients who have disease control after 12 months until confirmed objective disease progression.
Following completion or discontinuation of treatment, patients will enter a follow-up period.
- Being tested
- MEDI4736, Tremelimumab, MEDI4736 + Tremelimumab
- Keywords
- Head and neck cancer; SCCHN
- Medical subject headings
- Recurrence, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI4736Drug
MEDI4736 monotherapy
TremelimumabDrug
Tremelimumab monotherapy
MEDI4736 + TremelimumabDrug
MEDI4736 + Tremelimumab combination therapy
| Study group | Role | What they receive |
|---|---|---|
| MEDI4736 | Experimental | MEDI4736 monotherapy Receives: Drug: MEDI4736 |
| Tremelimumab | Experimental | Tremelimumab monotherapy Receives: Drug: Tremelimumab |
| MEDI4736 + Tremelimumab | Experimental | MEDI4736 + Tremelimumab combination therapy Receives: Drug: MEDI4736 + Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate at 6 Months
Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses
Measured: After 6 months
Objective Response Rate at 12 Months
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions.
Measured: After 12 months
Secondary outcomes (11)
Best Objective Response
The best response a patient has had during their time in the study
Measured: After 12 months
Duration of Response - Participants Remaining in Response
Participants remaining in response - based on BICR assessments according to RECIST v1.1. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.
Measured: After 12 months
Time to Response
Time to response in patients with objective response based on BICR assessments according to RECIST 1.1
Measured: After 12 months
Time to Onset of Response From First Dose
Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1
Measured: After 12 months
Disease Control Rate (DCR)
Disease control rate (DCR) at 6 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.
Measured: After 6 months
Disease Control Rate (DCR)
Disease control rate (DCR) at 12 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.
Measured: After 12 months
Progression-free Survival (PFS)
Progression status at 6 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.
Measured: After 6 months
Progression-free Survival (PFS)
Progression status at 12 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.
Measured: After 12 months
Overall Survival
Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status or patients who were lost to follow-up.
Measured: After 12 months
Quality of Life
Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires: -The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3. -Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H\&N35. The symptom and QoL/function improvement rate was defined as the number (%) of patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10 or EORTC QLQ-C30 scales) in that symptom/function from baseline. For QLQ-H\&N35A a minimum clinically meaningful change was defined as a change in the score from baseline of >10 for scales/items
Measured: After 12 months
Duration of Response
Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1. Duration of response was the time from the first documentation of Complete response/Partial response (which was subsequently confirmed) until the date of progression, death, or the last evaluable RECIST assessment for patients that did not progress. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off (per RECIST v1.1 as assessed by BICR).
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study start15 Apr 2015
- Primary completion26 Sep 2016
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent/Metastatic Squamous Cell Carcinoma of Head & NeckStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- Magdalena Wrona, Study director, Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.comLillian Siu, MD, Principal investigator, Princess Margaret Hospital in Toronto, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319044
- Sponsor's protocol ID
- D4193C00003
- Status last verified
- Sep 2020
- First submitted
- 12 Dec 2014
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Siu LL, Even C, Mesia R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Brana I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J. Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.
PubMed 30383184
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT02319044
- Acronym / sponsor ID
- D4193C00003
- Keywords
- Head and neck cancer; SCCHN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Posted 19 Jun 2018
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 determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.
Detailed description
This is a randomized, open-label, multi-center, global, Phase II study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and tremelimumab monotherapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease, that must have contained a platinum agent.
Patients will be randomized in a stratified manner according to prognostic factors, including human papillomavirus (HPV) status and smoking status to achieve a balance between treatments for each of the factors. Patients will be randomized in a 1:1:2 fashion to receive MEDI4736 monotherapy, tremelimumab monotherapy, or MEDI4736 + tremelimumab combination.
All treatments will be administered beginning on Day 0 for 12 months or until confirmed progression of disease; unless, in the Investigator's opinion, the patient continues to receive benefit from the treatment), initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Patients with confirmed progression of disease who, in the Investigator's opinion, continue to receive benefit from their assigned investigational product and who meet the criteria for treatment in the setting of progression of disease may continue to receive their assigned investigational product treatment for a maximum of 12 months after consultation with the Sponsor and at the Investigator's discretion. The monotherapy arms (tremelimumab and MEDI4736) should be discontinued if there is confirmed progression of disease following a previous response in target lesions (complete response or partial response).
Tumor assessments will be performed using computed tomography or magnetic resonance imaging. Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (q8w) for the first 48 weeks (relative to the date of the first infusion) then q12w in patients who have disease control after 12 months until confirmed objective disease progression.
Following completion or discontinuation of treatment, patients will enter a follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MEDI4736 | Experimental | Drug: MEDI4736MEDI4736 monotherapy |
| Tremelimumab | Experimental | Drug: TremelimumabTremelimumab monotherapy |
| MEDI4736 + Tremelimumab | Experimental | Drug: MEDI4736 + TremelimumabMEDI4736 + Tremelimumab combination therapy |
Who may qualify
- Ages
- 18 to 96 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years;
- Written informed consent obtained from the patient/legal representative;
- Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent; Patients who have only received chemo-radiation with curative intent for treatment of their locally advanced disease or recurrent disease are not eligible. Patients who received concurrent chemo-radiation as part of treatment of their recurrent disease are also not eligible.
- Written consent to provide newly acquired tumor tissue (preferred) or archival tissue for the purpose of establishing PD-L1 status.
- Confirmed PD-L1-negative SCCHN by Ventana SP263;
Key exclusion criteria (21 listed)
- Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck;
- Received more than 1 regimen for recurrent or metastatic disease
- Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment;
- Receipt of any investigational anticancer therapy within 28 days or 5 half-lives;
- Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment;
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 monotherapy | Drug | MEDI4736 |
| TremelimumabTremelimumab monotherapy | Drug | Tremelimumab |
| MEDI4736 + TremelimumabMEDI4736 + Tremelimumab combination therapy | Drug | MEDI4736 + Tremelimumab |
Primary outcome
Objective Response Rate at 6 Months
Time frame: After 6 months
Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses
Objective Response Rate at 12 Months
Time frame: After 12 months
Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions.
11 secondary outcomes
Best Objective Response
Time frame: After 12 months
Duration of Response - Participants Remaining in Response
Time frame: After 12 months
Time to Response
Time frame: After 12 months
Time to Onset of Response From First Dose
Time frame: After 12 months
Disease Control Rate (DCR)
Time frame: After 6 months
Disease Control Rate (DCR)
Time frame: After 12 months
Progression-free Survival (PFS)
Time frame: After 6 months
Progression-free Survival (PFS)
Time frame: After 12 months
Overall Survival
Time frame: After 12 months
Quality of Life
Time frame: After 12 months
Duration of Response
Time frame: After 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30383184Siu LL, Even C, Mesia R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Brana I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J. Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.
- Redacted ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
RecruitingPhase 3
A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
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.
Magdalena Wrona study director
Medical Scientist AstraZeneca Magdalena.Wrona@astrazeneca.com
Lillian Siu, MD principal investigator
Princess Margaret Hospital in Toronto, Ontario
125 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI4736, Tremelimumab and MEDI4736 + Tremelimumab in people with Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck, run by AstraZeneca at 125 sites in 15 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 9 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in United States, France, Spain, Hungary, Canada and 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate at 6 Months (time frame: After 6 months). The study lists 2 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 NCT02319044, 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 29 Sep 2020.