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Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

NCT ID: NCT02551159

Last Updated: 2021-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

823 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-15

Study Completion Date

2021-05-21

Brief Summary

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This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

Detailed Description

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Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.

Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

MEDI4736 monotherapy.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type BIOLOGICAL

Anti-PD-L1 antibody

Combination Therapy

MEDI4736+Tremelimumab combination therapy

Group Type EXPERIMENTAL

Tremelimumab

Intervention Type BIOLOGICAL

Anti-CTLA-4 Antibody

MEDI4736+Tremelimumab

Intervention Type BIOLOGICAL

Standard of Care

Standard of Care treatment

Group Type ACTIVE_COMPARATOR

Cetuximab

Intervention Type BIOLOGICAL

Monoclonal Antibody

5-fluorouracil (5FU)

Intervention Type DRUG

Chemotherapy Agent

Cisplatin

Intervention Type DRUG

Chemotherapy agent

Carboplatin

Intervention Type DRUG

Chemotherapy Agent

Interventions

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MEDI4736

Anti-PD-L1 antibody

Intervention Type BIOLOGICAL

Tremelimumab

Anti-CTLA-4 Antibody

Intervention Type BIOLOGICAL

MEDI4736+Tremelimumab

Intervention Type BIOLOGICAL

Cetuximab

Monoclonal Antibody

Intervention Type BIOLOGICAL

5-fluorouracil (5FU)

Chemotherapy Agent

Intervention Type DRUG

Cisplatin

Chemotherapy agent

Intervention Type DRUG

Carboplatin

Chemotherapy Agent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years at the time of screening
2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).
3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.
4. No prior systemic chemotherapy for recurrent or metastatic disease
5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
6. No prior exposure to immune-mediated therapy,

2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Olsson

Role: STUDY_DIRECTOR

Tanguy Seiwert

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637

Locations

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Fort Myers, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Morristown, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Nashville, Tennessee, United States

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Graz, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Namur, , Belgium

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Barretos, , Brazil

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Curitiba, , Brazil

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Florianópolis, , Brazil

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Ijuí, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Rio de Janeiro, , Brazil

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Santo André, , Brazil

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Santo André, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Brest, , France

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Dijon, , France

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Lyon, , France

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Nice, , France

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Paris, , France

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Poitiers, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Berlin, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Frankfurt am Main, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Mainz, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Heraklion, , Greece

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Thessaloniki, , Greece

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Bangalore, , India

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Bangalore, , India

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Bengaluru, , India

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Gurgaon, , India

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Karamsad, , India

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Madurai, , India

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Pune, , India

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Cona, , Italy

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Florence, , Italy

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Messina, , Italy

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Milan, , Italy

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Padua, , Italy

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Palermo, , Italy

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Salerno, , Italy

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Siena, , Italy

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Torino, , Italy

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Akashi-shi, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Hirakata-shi, , Japan

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Isehara-shi, , Japan

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Kagoshima, , Japan

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Kanazawa, , Japan

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Kitaadachi-gun, , Japan

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Kobe, , Japan

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Kōtoku, , Japan

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Natori-shi, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Sapporo, , Japan

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Sapporo, , Japan

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Sayama, , Japan

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Sunto-gun, , Japan

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Takatsuki-shi, , Japan

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Toyoake-shi, , Japan

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Yokohama, , Japan

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Cebu City, , Philippines

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Las Piñas, , Philippines

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Quezon City, , Philippines

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Bialystok, , Poland

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Bielsko-Biala, , Poland

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Gdansk, , Poland

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Gdynia, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Suceava, , Romania

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Arkhangelsk, , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Sochi, , Russia

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Ufa, , Russia

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Yekaterinburg, , Russia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Cheongju-si, , South Korea

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Hwasun-gun, , South Korea

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Incheon, , South Korea

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Seogu, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Badajoz, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Jaén, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Marbella, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Hat Yai, , Thailand

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Pathum Thani, , Thailand

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kapitanivka Village, , Ukraine

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Kharkiv Region, , Ukraine

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Kirovohrad, , Ukraine

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Kryvyi Rih, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Sumy, , Ukraine

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Vinnytsia, , Ukraine

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Bebington, , United Kingdom

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Birmingham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Sutton, , United Kingdom

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Taunton, , United Kingdom

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Hanoi, , Vietnam

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Hanoi, , Vietnam

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Hà Nội, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Austria Belgium Brazil Canada France Germany Greece India Italy Japan Philippines Poland Romania Russia Slovakia South Korea Spain Taiwan Thailand Ukraine United Kingdom Vietnam

References

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Seiwert TY, Wildsmith S, Fayette J, Harrington K, Gillison M, Ahn MJ, Takahashi S, Weiss J, Machiels JP, Baxi S, Baker V, Evans B, Morsli N, Jill Walker, Real K, L'Hernault A, Psyrri A. Outcomes in biomarker-selected subgroups from the KESTREL study of durvalumab and tremelimumab in recurrent or metastatic head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2024 Mar 2;73(4):70. doi: 10.1007/s00262-024-03643-3.

Reference Type DERIVED
PMID: 38430375 (View on PubMed)

Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.

Reference Type DERIVED
PMID: 33684371 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419LC00001&attachmentIdentifier=b4025180-dfd4-4783-a723-cba099a5d9fb&fileName=D419LC00001_-_Protocol_v12__-redact.pdf&versionIdentifier=

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Related Info

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Related Info

Other Identifiers

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D419LC00001

Identifier Type: -

Identifier Source: org_study_id