Head and Neck Neoplasms Clinical Trial
Official title:
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
| Verified date | February 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
| Status | Active, not recruiting |
| Enrollment | 804 |
| Est. completion date | August 16, 2024 |
| Est. primary completion date | May 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study. - Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed. - Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1 - Is eligible for definitive CRT and not considered for primary surgery based on investigator decision - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days prior to receiving the first dose of study therapy - Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy - Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy Exclusion Criteria: - Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy - Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in clinical studies with pembrolizumab - Has received a live vaccine within 30 days prior to the first dose of study therapy - Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer - Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study - Has not recovered from major surgery prior to starting study therapy - Has known active Hepatitis B or C - Has known history of Human Immunodeficiency Virus (HIV) - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment. - Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has had previous allogeneic tissue/solid organ transplant - Has active infection requiring systemic therapy - Has a history of severe hypersensitivity reaction to pembrolizumab, Cisplatin or radiotherapy or their analogs - Is pregnant or breast feeding or expecting to conceive or father children throughout the study period and for up to 180 days after the last dose of study therapy |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital ( Site 0303) | Adelaide | South Australia |
| Australia | Blacktown Hospital Western Sydney Local Health District ( Site 0304) | Blacktown | New South Wales |
| Australia | Princess Alexandra Hospital ( Site 0305) | Brisbane | Queensland |
| Australia | Royal Brisbane and Women s Hospital ( Site 0302) | Herston | Queensland |
| Australia | Liverpool Hospital ( Site 0301) | Liverpool | New South Wales (Australia) |
| Australia | Peter MacCallum Cancer Centre ( Site 0300) | Melbourne | Victoria |
| Austria | Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601) | Graz | |
| Austria | Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603) | Linz | |
| Austria | Landeskrankenhaus Salzburg ( Site 0600) | Salzburg | |
| Austria | Allgemeines Krankenhaus der Stadt Wien ( Site 0602) | Vienna/Wien | |
| Belgium | Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651) | Brussels | |
| Belgium | UZ Gent ( Site 0650) | Gent | |
| Belgium | UZ Leuven Campus Gasthuisberg ( Site 0652) | Leuven | |
| Belgium | C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654) | Liege | |
| Belgium | Clinique et Maternite Sainte-Elisabeth ( Site 0653) | Namur | |
| Brazil | Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003) | Barretos | Sao Paulo |
| Brazil | Centro Regional Integrado de Oncologia ( Site 0002) | Fortaleza | Ceara |
| Brazil | Liga Norte Riograndense Contra o Cancer ( Site 0005) | Natal | Rio Grande Do Norte |
| Brazil | Hospital de Clinicas de Porto Alegre ( Site 0011) | Porto Alegre | RS |
| Brazil | Hospital Nossa Senhora da Conceicao ( Site 0001) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008) | Ribeirao Preto | |
| Brazil | Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010) | Rio de Janeiro | |
| Brazil | Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006) | Salvador | Bahia |
| Brazil | Instituto do Cancer de Sao Paulo - ICESP ( Site 0004) | Sao Paulo | SP |
| Canada | Tom Baker Cancer Centre ( Site 0063) | Calgary | Alberta |
| Canada | Cross Cancer Institute ( Site 0064) | Edmonton | Alberta |
| Canada | Juravinski Cancer Centre ( Site 0062) | Hamilton | Ontario |
| Canada | London Health Sciences Centre ( Site 0055) | London | Ontario |
| Canada | McGill University Health Centre ( Site 0061) | Montreal | Quebec |
| Canada | The Ottawa Hospital - Cancer Care ( Site 0052) | Ottawa | Ontario |
| Canada | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057) | Sherbrooke | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0051) | Toronto | Ontario |
| Colombia | Centro de Investigacion Clinica del Country ( Site 0155) | Bogota | |
| Colombia | Centro Medico Imbanaco de Cali S.A ( Site 0156) | Cali | Valle Del Cauca |
| Colombia | Fundacion Valle del Lili ( Site 0150) | Cali | Valle Del Cauca |
| Colombia | Hospital Pablo Tobon Uribe ( Site 0151) | Medellin | Antioquia |
| Czechia | FN Brno. ( Site 0703) | Brno | |
| Czechia | Fakultni Nemocnice Hradec Kralove ( Site 0705) | Hradec Kralove | |
| Czechia | Fakultni nemocnice Olomouc ( Site 0701) | Olomouc | |
| Czechia | Fakultni nemocnice Ostrava ( Site 0702) | Ostrava | |
| Czechia | 2. LF UK a FN Motol ( Site 0704) | Praha | |
| Czechia | Nemocnice Na Bulovce ( Site 0700) | Praha 8 | |
| France | Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760) | Le Mans | |
| France | Clinique Francois Chenieux ( Site 0757) | Limoges | |
| France | Institut Claudius Regaud ( Site 0754) | Toulouse Cedex 09 | |
| France | Institut De Cancerologie De Lorraine ( Site 0758) | Vandoeuvre les Nancy | |
| France | Institut Gustave Roussy ( Site 0759) | Villejuif | |
| Germany | Universitätsklinikum Erlangen ( Site 0801) | Erlangen | |
| Germany | SRH Waldklinikum Gera GmbH ( Site 0802) | Gera | |
| Germany | Universitares Cancer Center Hamburg - UCCH ( Site 0811) | Hamburg | |
| Germany | Medizinische Hochschule Hannover ( Site 0807) | Hannover | |
| Germany | Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803) | Luebeck | |
| Germany | Klinikum der Universitaet Munchen ( Site 0810) | Munchen | |
| Germany | Universitaetsklinik Ulm ( Site 0804) | Ulm | |
| Israel | Rambam MC ( Site 0903) | Haifa | |
| Israel | Hadassah Ein Karem Jerusalem ( Site 0902) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 0904) | Petah Tikva | |
| Israel | Sheba MC ( Site 0901) | Ramat Gan | |
| Israel | Tel Aviv Sourasky Medical Center ( Site 0900) | Tel Aviv | |
| Italy | Azienda Ospedaliero Universitaria Careggi ( Site 0955) | Firenze | |
| Italy | Azienda Ospedaliera San Paolo ( Site 0952) | Milano | |
| Italy | Istituto Europeo di Oncologia ( Site 0953) | Milano | |
| Italy | Istituto Nazionale Tumori ( Site 0950) | Milano | |
| Italy | Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954) | Modena | MO |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951) | Napoli | |
| Italy | Istituto Oncologico Veneto ( Site 0957) | Padova | |
| Italy | Fondazione IRCCS - Policlinico San Matteo ( Site 0960) | Pavia | |
| Japan | Hyogo Cancer Center ( Site 0354) | Akashi | Hyogo |
| Japan | Chiba Cancer Center ( Site 0358) | Chiba | |
| Japan | Hiroshima University Hospital ( Site 0352) | Hiroshima | |
| Japan | National Cancer Center Hospital East ( Site 0350) | Kashiwa | Chiba |
| Japan | Kagawa University Hospital ( Site 0359) | Kita-gun | Kagawa |
| Japan | Miyagi Cancer Center ( Site 0353) | Natori | Miyagi |
| Japan | Osaka International Cancer Institute ( Site 0355) | Osaka | |
| Japan | Hokkaido University Hospital ( Site 0351) | Sapporo | Hokkaido |
| Japan | Medical Hospital, Tokyo Medical And Dental University ( Site 0356) | Tokyo | |
| Japan | The Cancer Institute Hospital of JFCR ( Site 0357) | Tokyo | |
| Korea, Republic of | Chungbuk National University Hospital ( Site 0454) | Cheongju si | Chungcheongbuk Do |
| Korea, Republic of | Chungnam National University Hospital ( Site 0455) | Daejeon | |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 0453) | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Samsung Medical Center ( Site 0450) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 0452) | Seoul | |
| Netherlands | Noordwest Ziekenhuisgroep NWZ ( Site 1350) | Alkmaar | |
| Netherlands | VU Medisch Centrum ( Site 1352) | Amsterdam | |
| Netherlands | UMCG ( Site 1351) | Groningen | |
| Netherlands | UMC St. Radboud ( Site 1356) | Nijmegen | |
| Netherlands | Erasmus University Medical Center ( Site 1354) | Rotterdam | |
| New Zealand | Capital & Coast District Health Board - Wellington Hospital ( Site 0400) | Wellington | Newtown |
| Poland | Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005) | Bielsko-Biala | |
| Poland | Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007) | Gdynia | |
| Poland | Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010) | Gliwice | |
| Poland | Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008) | Krakow | |
| Poland | Zachodniopomorskie Centrum Onkologii ( Site 1013) | Szczecin | |
| Poland | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000) | Warszawa | |
| Poland | Mazowiecki Szpital Onkologiczny ( Site 1015) | Wieliszew | Mazowieckie |
| Poland | Dolnoslaskie Centrum Onkologii. ( Site 1001) | Wroclaw | Dolnoslaskie |
| Spain | H.U. Vall de Hebron ( Site 1052) | Barcelona | |
| Spain | Hospital Duran i Reynals ( Site 1053) | Hospitalet de Llobregat | |
| Spain | Hospital Clinico San Carlos ( Site 1051) | Madrid | |
| Spain | Hospital Doce de Octubre ( Site 1054) | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal ( Site 1055) | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria ( Site 1056) | Malaga | |
| Spain | Hospital Gral Universitario de Valencia ( Site 1050) | Valencia | |
| Taiwan | Chang Gung Medical Foundation - Kaohsiung ( Site 0501) | Kaohsiung | |
| Taiwan | Taichung Veterans General Hospital ( Site 0506) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 0503) | Tainan | |
| Taiwan | MacKay Memorial Hospital ( Site 0505) | Taipei | |
| Taiwan | National Taiwan University Hospital ( Site 0500) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 0504) | Taipei | |
| Taiwan | Linkou Chang Gung Memorial Hospital ( Site 0502) | Taoyuan | |
| Turkey | Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103) | Adana | |
| Turkey | Ankara Sehir Hastanesi ( Site 1108) | Ankara | |
| Turkey | Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102) | Ankara | |
| Turkey | Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100) | Istanbul | |
| Turkey | Medipol Universite Hastanesi ( Site 1104) | Istanbul | |
| Turkey | Medical Park Izmir Hastanesi ( Site 1109) | Izmir | |
| Turkey | Kocaeli Universitesi Tip Fakultesi ( Site 1106) | Kocaeli | |
| Turkey | Inonu Universitesi Tip Fakultesi ( Site 1101) | Malatya | |
| United Kingdom | Ipswich Hospital ( Site 1207) | Ipswich | Suffolk |
| United Kingdom | Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204) | London | |
| United Kingdom | St Bartholomew s Hospital ( Site 1205) | London | |
| United Kingdom | The Royal Marsden Foundation Trust ( Site 1200) | London | |
| United Kingdom | Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206) | Norwich | Norfolk |
| United Kingdom | Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208) | Preston | |
| United Kingdom | University Hospital Southampton NHS Foundation Trust ( Site 1203) | Southampton | |
| United Kingdom | University Hospital of North Staffordshire ( Site 1202) | Stoke-On-Trent | Staffordshire |
| United Kingdom | Royal Marsden NHS Foundation Trust ( Site 1201) | Sutton | |
| United States | University of Michigan Hospital and Health Systems ( Site 0267) | Ann Arbor | Michigan |
| United States | Texas Oncology-Arlington North ( Site 8005) | Arlington | Texas |
| United States | Texas Oncology-Austin Central ( Site 8002) | Austin | Texas |
| United States | Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281) | Baton Rouge | Louisiana |
| United States | St. Vincent Healthcare Frontier Cancer Center ( Site 0286) | Billings | Montana |
| United States | University of Virginia Health System ( Site 0261) | Charlottesville | Virginia |
| United States | Rush University Medical Center ( Site 0260) | Chicago | Illinois |
| United States | Oncology Hematology Care, Inc. ( Site 8003) | Cincinnati | Ohio |
| United States | Barbara Ann Karmanos Cancer Institute ( Site 0272) | Detroit | Michigan |
| United States | St. Luke's Cancer Center - Anderson ( Site 0251) | Easton | Pennsylvania |
| United States | Willamette Valley Cancer Institute and Research Center ( Site 8000) | Eugene | Oregon |
| United States | St. Francis Hospital Cancer Center ( Site 1461) | Greenville | South Carolina |
| United States | Indiana University ( Site 0264) | Indianapolis | Indiana |
| United States | Comprehensive Cancer Centers of Nevada ( Site 8004) | Las Vegas | Nevada |
| United States | Texas Oncology PA ( Site 8001) | Longview | Texas |
| United States | UCLA Medical Center ( Site 0273) | Los Angeles | California |
| United States | Smilow Cancer Hospital at Yale New Haven ( Site 0256) | New Haven | Connecticut |
| United States | University of Rochester - James P. Wilmot Cancer Center ( Site 0255) | Rochester | New York |
| United States | University of California San Francisco ( Site 0274) | San Francisco | California |
| United States | St. Joseph Heritage Healthcare ( Site 0254) | Santa Rosa | California |
| United States | Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269) | Seattle | Washington |
| United States | Medical Oncology Associates (Summit Cancer Centers) ( Site 0257) | Spokane | Washington |
| United States | Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290) | Springfield | Missouri |
| United States | University of Massachusetts Memorial Medical Center ( Site 0285) | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Spain, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event-free Survival (EFS) | EFS is the time from date of randomization to the date of first record of any of the following events: death due to any cause; progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) or biopsy as indicated for locoregional progression or recurrence or distant metastasis. As well as the first record of the following types of surgery: salvage surgery for persistent or residual disease at the primary tumor site requiring surgical removal when invasive cancer is present on final pathology; neck dissection or surgery (performed for clinical or radiological disease progression per RECIST 1.1) = 20 weeks from end of CRT when invasive cancer is present; or neck dissection or surgery >20 weeks from end of CRT when invasive cancer is present. From product-limit (Kaplan-Meier) method for censored data. | Up to approximately 62 months | |
| Secondary | Overall Survival (OS) | OS is the time from randomization to death due to any cause, from product-limit (Kaplan-Meier) method for censored data. The hypothesis was that pembrolizumab in combination with CRT is superior to placebo in combination with CRT; but based on the protocol, because the statistical criterion for success in the primary EFS hypothesis was not met, the OS hypothesis was not tested | Up to approximately 62 months | |
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. | From time of first dose of study treatment until 90 days after last dose (up to approximately 19 months) | |
| Secondary | Number of Participants Discontinuing Study Drug Due to an AE | An AE is any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. | From time of first dose of study treatment until the end of treatment (up to approximately 16 months) | |
| Secondary | Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) | The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) contains 30 items and measures five functional dimensions (physical, role, emotional, cognitive and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, so that a higher score indicates a better overall GHS. A change from baseline of 10 points on the 100-point EORTC QLQ-C30 scale is considered as clinically relevant. Based on a constrained longitudinal data analysis (cLDA) model with the patient reported outcomes (PRO) scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of human papilloma virus (HPV) status and overall cancer stage. | Prior to the first dose of study treatment (Baseline) and up to Week 45 | |
| Secondary | Change From Baseline in Swallowing, Speech, and Pain Symptoms | EORTC QLQ Head and Neck Questionnaire (H&N35) consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality), Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Change from baseline in swallowing, speech, and pain symptoms was measured. A change from baseline of 10 points on the 100-point EORTC QLQ-H&N35 is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage. | Prior to the first dose of study treatment (Baseline) and up to Week 45 | |
| Secondary | Change From Baseline in Physical Functioning | Participant responded to 5 questions from the EORTC QLQ-C30 about their physical functioning scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100, where a higher score indicates a better quality of life. A change from baseline of 10 points on the 100-point scale is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage. | Prior to the first dose of study treatment (Baseline) and up to Week 45 |
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