CONTACT-03: A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Study Details
Study Description
Brief Summary
This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Atezo+Cabo Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day. |
Drug: Atezolizumab
Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.
Other Names:
Drug: Cabozantinib
Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
Other Names:
|
Active Comparator: Cabozantinib Participants will receive cabozantinib every day. |
Drug: Cabozantinib
Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS), as assessed by Independent Review Facility (IRF) [Randomization up to approximately 27 months]
Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, as assessed by Independent Review Facility (IRF-PFS) or death from any cause, whichever occurs first.
- Overall survival (OS) [Randomization up to approximately 52 months]
Overall survival (OS), defined as the time from randomization to death from any cause.
Secondary Outcome Measures
- PFS Assessed by the Investigators (INV-PFS) [Randomization up to approximately 27 months]
PFS assessed by the investigators (INV-PFS), defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first).
- Investigator Assessed Objective Response Rate (INV-ORR) [Randomization up to approximately 27 months]
INV-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
- IRF Assessed Objective Response Rate (IRF-ORR) [Randomization up to approximately 27 months]
IRF-ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart according to RECIST v1.1.
- Investigator Assessed Duration of Objective Response (INV-DOR) [Randomization up to approximately 27 months]
INV-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
- IRF Assessed DOR (IRF-DOR) [Randomization up to approximately 27 months]
IRF-DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first) according to RECIST v1.1.
- Percentage of Participants With Adverse Events [Randomization up to approximately 27 months]
- Atezolizumab Concentrations [At pre-defined intervals from first administration of study drug up to approximately 27 months]
- Cabozantinib Concentrations [At pre-defined intervals from first administration of study drug up to approximately 27 months]
- Prevalence of Anti-Drug Antibodies (ADAs) to Atezolizumab [Baseline]
- Incidence of ADAs to Atezolizumab During the Study [At pre-defined intervals from first administration of study drug up to approximately 27 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
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Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
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Measurable disease per RECIST v1.1
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Evaluable IMDC risk score
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Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
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KPS score of >=70
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Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
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Adequate hematologic and end-organ function
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Negative HIV test at screening
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Negative hepatitis B testing at screening
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Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
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For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
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For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
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Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
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Patients received cabozantinib at any time prior to screening
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Patients who received more than one ICI treatment in the locally advanced or metastatic setting
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Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
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Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
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Symptomatic, untreated, or actively progressing CNS metastases
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History of leptomeningeal disease
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Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
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Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
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History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
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Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
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Active tuberculosis
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Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
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Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
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Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
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Pharmacologically uncompensated, symptomatic hypothyroidism
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Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
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Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
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Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
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History of congenital QT syndrome
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History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
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Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Arizona | Tucson | Arizona | United States | 85724-5030 |
2 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
3 | UC San Diego Health System | La Jolla | California | United States | 92093 |
4 | UCLA | Los Angeles | California | United States | 90095 |
5 | University of Colorado | Aurora | Colorado | United States | 80045 |
6 | Rocky Mountain Cancer Center - Denver | Littleton | Colorado | United States | 80120 |
7 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
8 | Woodlands Medical Specialists, P.A. | Pensacola | Florida | United States | 32503 |
9 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
10 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building | Baltimore | Maryland | United States | 21287 |
11 | MGH | Boston | Massachusetts | United States | 02114 |
12 | Beth Israel Deaconess Med Ctr | Boston | Massachusetts | United States | 02215 |
13 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
14 | Minnesota Oncology Hematology | Saint Paul | Minnesota | United States | 55102 |
15 | Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley | Las Vegas | Nevada | United States | 89169 |
16 | Memorial Sloan Kettering - Monmouth | Middletown | New Jersey | United States | 07748 |
17 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
18 | New York Oncology Hematology,P.C.-Albany | Albany | New York | United States | 12208 |
19 | Montefiore Medical Center | Bronx | New York | United States | 10461 |
20 | Memorial Sloan Kettering Cancer Center - Commack | Commack | New York | United States | 11725 |
21 | MSKCC @ West Harrison | Harrison | New York | United States | 10604 |
22 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
23 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
24 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
25 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
26 | Cleveland Clinic | Cleveland | Ohio | United States | 44106 |
27 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
28 | Texas Onc-Central Austin CA Ct | Austin | Texas | United States | 78731 |
29 | University Of Utah | Salt Lake City | Utah | United States | 84108 |
30 | Virginia Cancer Specialists - Gainsville | Gainesville | Virginia | United States | 20155 |
31 | Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | Argentina | C1125ABD | |
32 | Inst. Alexander Fleming; Oncologia | Buenos Aires | Argentina | C1426ANZ | |
33 | Hospital Britanico | Ciudad Autonoma Bs As | Argentina | C1280AEB | |
34 | Centro Medico Austral OMI | Ciudad Autonoma Buenos Aires | Argentina | C1019ABS | |
35 | Macquarie University Hospital | Macquarie Park | New South Wales | Australia | 2109 |
36 | Orange Hospital | Orange | New South Wales | Australia | 2800 |
37 | Icon Cancer Foundation | South Brisbane | Queensland | Australia | 4101 |
38 | Bendigo Cancer Centre | Bendigo | Victoria | Australia | 3550 |
39 | Cancer Care Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
40 | St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
41 | Princess Margaret Cancer Center | Toronto | Ontario | Canada | M5G 1Z5 |
42 | Herlev Hospital; Afdeling for Kræftbehandling | Herlev | Denmark | 2730 | |
43 | CHU Besançon - Hôpital Jean Minjoz | Besançon Cedex | France | 25030 | |
44 | CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre | Bordeaux | France | 33075 | |
45 | Centre Francois Baclesse; Oncologie | Caen | France | 14076 | |
46 | Centre Jean Perrin; Oncologie | Clermont Ferrand | France | 63011 | |
47 | Centre Oscar Lambret; Chir Cancerologie General | Lille | France | 59000 | |
48 | Centre Leon Berard; Departement Oncologie Medicale | Lyon | France | 69373 | |
49 | Centre Antoine Lacassagne | Nice | France | 06189 | |
50 | Institut de cancerologie du Gard | Nimes | France | 30029 | |
51 | Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale | Paris | France | 75908 | |
52 | ICANS | Strasbourg | France | 67200 | |
53 | Institut Gustave Roussy; Oncologie Medicale | Villejuif | France | 94800 | |
54 | Zeisigwaldkliniken Bethanien | Chemnitz | Germany | 09130 | |
55 | Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie | Frankfurt | Germany | 60590 | |
56 | Universitaetsklinikum Freiburg; Urology | Freiburg | Germany | 79106 | |
57 | Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie | Halle (Saale) | Germany | 06120 | |
58 | Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie | Hamburg | Germany | 20246 | |
59 | Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation | Hannover | Germany | 30625 | |
60 | Universitaetsklinikum Muenster; Urology | Muenster | Germany | 48149 | |
61 | Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik | München | Germany | 81675 | |
62 | Universitätsklinikum Tübingen; Klinik für Urologie | Tübingen | Germany | 72076 | |
63 | Universitätsklinikum Ulm; Klinik für Urologie | Ulm | Germany | 89081 | |
64 | Attikon University General Hospital | Ahens | Greece | 124 64 | |
65 | Alexandras General Hospital of Athens; Oncology Department | Athens | Greece | 115 28 | |
66 | Athens Medical Center; Dept. of Oncology | Athens | Greece | 151 25 | |
67 | University Hospital of Larissa;Department of Medical Oncology | Larissa | Greece | 411 10 | |
68 | Papageorgiou General Hospital; Medical Oncology | Thessaloniki | Greece | 564 29 | |
69 | Diavalkaniko Hospital | Thessaloniki | Greece | 570 01 | |
70 | Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica | Napoli | Campania | Italy | 80131 |
71 | Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | Italy | 40138 |
72 | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | Italy | 47014 |
73 | Irccs Centro Di Riferimento Oncologico (CRO); SOC Oncologia Medica A | Aviano (PN) | Friuli-Venezia Giulia | Italy | 33081 |
74 | Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica | Roma | Lazio | Italy | 00168 |
75 | ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica | Brescia | Lombardia | Italy | 25123 |
76 | Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milano | Lombardia | Italy | 20133 |
77 | Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica | Pavia | Lombardia | Italy | 27100 |
78 | Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia | Rozzano | Lombardia | Italy | 20089 |
79 | Ospedale Di Macerata; Oncologia | Macerata | Marche | Italy | 62100 |
80 | Fondazione del Piemonte per l'Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare | Candiolo (TO) | Piemonte | Italy | 10060 |
81 | A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria | Bari | Puglia | Italy | 70124 |
82 | Azienda Ospedaliera S. Maria - Terni; Oncologia | Terni | Umbria | Italy | 05100 |
83 | A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche | Verona | Veneto | Italy | 37134 |
84 | Kyushu University Hospital | Fukuoka | Japan | 812-8582 | |
85 | Hokkaido University Hospital | Hokkaido | Japan | 060-8648 | |
86 | University of Tsukuba Hospital | Ibaraki | Japan | 305-8576 | |
87 | Yokohama City University Hospital | Kanagawa | Japan | 236-0004 | |
88 | Okayama University Hospital | Okayama | Japan | 700-8558 | |
89 | Osaka Metropolitan University Hospital | Osaka | Japan | 545-8586 | |
90 | Kindai University Hospital | Osaka | Japan | 589-8511 | |
91 | Tokushima University Hospital | Tokushima | Japan | 770-8503 | |
92 | Keio University Hospital | Tokyo | Japan | 160-8582 | |
93 | Tokyo Women's Medical University Hospital | Tokyo | Japan | 162-8666 | |
94 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
95 | National Cancer Center | Goyang-si | Korea, Republic of | 10408 | |
96 | CHA Bundang Medical Center | Gyeonggi-do | Korea, Republic of | 13496 | |
97 | Pusan National University Yangsan Hospital | Gyeongsangnam-do | Korea, Republic of | 50612 | |
98 | Chonnam National University Hwasun Hospital | Jeollanam-do | Korea, Republic of | 58128 | |
99 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
100 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
101 | Kangbuk Samsung Medical Center | Seoul | Korea, Republic of | 03181 | |
102 | Severance Hospital | Seoul | Korea, Republic of | 03722 | |
103 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
104 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
105 | Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny | Brzozów | Poland | 36-200 | |
106 | Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii | Bydgoszcz | Poland | 85-796 | |
107 | SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej | Bytom | Poland | 41-902 | |
108 | Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Poland | 90-242 | |
109 | Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | Poland | 05-400 | |
110 | Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego | Poznan | Poland | 60-570 | |
111 | Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. | Warszawa | Poland | 04-073 | |
112 | Wojskowy Instytut Medyczny; Klinika Onkologii | Warszawa | Poland | 04-141 | |
113 | Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii | Wrocław | Poland | 53-413 | |
114 | Regional Clinical Oncology Hospital | Yaroslavl | Jaroslavl | Russian Federation | 150054 |
115 | Branch of the company "Hadassah Medical LTD" | Innovatsionnogo Tsentra Skolkovo | Moskovskaja Oblast | Russian Federation | 121205 |
116 | MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy | Moscow | Moskovskaja Oblast | Russian Federation | 143422 |
117 | SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" | Moskva | Moskovskaja Oblast | Russian Federation | 111123 |
118 | National Medical Research Center for Surgery named after A.V. Vishnevsky | Moskva | Moskovskaja Oblast | Russian Federation | 117997 |
119 | AV Medical Ltd. | Sait-Petersburg Sankt Petersburg | Sankt Petersburg | Russian Federation | 196006 |
120 | Private Healthcare Institution Clinical Hospital RZhD Medicine | St. Petersburg | Sankt Petersburg | Russian Federation | 195271 |
121 | St-Petersburg Regional Oncology Dispensary; Oncology | Kuzmolovo | Russian Federation | 188663 | |
122 | FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | Russian Federation | 115478 | |
123 | Medical Center Avicenna; Urology | Novosibirsk | Russian Federation | 630099 | |
124 | Hospital Univ. Central de Asturias; Servicio de Oncologia | Oviedo | Asturias | Spain | 33011 |
125 | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | Spain | 8208 |
126 | Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | Spain | 39008 |
127 | Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | Spain | 14004 |
128 | Hospital Universitario Son Espases; Servicio de Oncologia | Palma De Mallorca | Islas Baleares | Spain | 07014 |
129 | Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | Spain | 28222 |
130 | Hospital Alvaro Cunqueiro; Servicio de Oncologia | Vigo | Pontevedra | Spain | 36213 |
131 | Vall d´Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | Spain | 08035 | |
132 | Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | Spain | 08041 | |
133 | Hospital Universitario de Burgos; Oncología | Burgos | Spain | 09006 | |
134 | Hospital San Pedro De Alcantara; Servicio de Oncologia | Caceres | Spain | 10003 | |
135 | Hospital Lucus Augusti; Servicio de Oncologia | Lugo | Spain | 27003 | |
136 | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | Spain | 28007 | |
137 | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | Spain | 28034 | |
138 | Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | Spain | 28040 | |
139 | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | Spain | 28041 | |
140 | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | Spain | 28046 | |
141 | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga | Spain | 29010 | |
142 | Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | Spain | 30120 | |
143 | Hospital de Navarra; Servicio de Oncologia | Navarra | Spain | 31008 | |
144 | Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla | Spain | 41013 | |
145 | Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia | Sevilla | Spain | 41014 | |
146 | Hospital Universitario la Fe; Servicio de Oncologia | Valencia | Spain | 46026 | |
147 | Royal Blackburn Hospital | Blackburn | United Kingdom | BB2 3HH | |
148 | Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | United Kingdom | LE1 5WW | |
149 | Barts & London School of Med; Medical Oncology | London | United Kingdom | EC1A 7BE | |
150 | Royal Marsden Hospital; Dept of Med-Onc | London | United Kingdom | SW3 6JJ | |
151 | Christie Hospital Nhs Trust; Medical Oncology | Manchester | United Kingdom | M2O 4BX | |
152 | Royal Marsden Hospital (Sutton) | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Hoffmann-La Roche
- Exelixis
- Chugai
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WO41994