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JOURNAL ONKOLOGIE – STUDIE

Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma

Rekrutierend

NCT-Nummer:
NCT04674683

Studienbeginn:
August 2021

Letztes Update:
27.07.2023

Wirkstoff:
HBI-8000 in combination with nivolumab, Placebo in combination with nivolumab

Indikation (Clinical Trials):
Melanoma, Neoplasm Metastasis, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
HUYABIO International, LLC.

Collaborator:
Bristol-Myers Squibb

Studienleiter

John T Ning, MD, PhD
Study Director
HUYABIO International, LLC.

Kontakt

Studienlocations
(3 von 142)

Charite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Vivantes Klinikum Spandau, Dermatologie und Allergologie
13585 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus TU Dresden, Klinik und Poliklinik f. Dermatologie
01307 Dresden,
(Sachsen)
GermanyRekrutierend» Google-Maps
Helios Klinikum Erfurt, Dermatologie und Allergologie
99089 Erfurt
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz
Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie
79104 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Heidelberg, NCT-Dermatoonkologie
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Koeln, Dermatologie und Venerologie,
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
23538 Luebeck
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Comprehensive Blood and Cancer Center
93309 Bakersfield
United StatesRekrutierend» Google-Maps
UC San Diego Moores Cancer Center
92037 La Jolla
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Innovative Clinical Research Institute (ICRI)
91105 Pasadena
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Emad Ibrahim, MD, INC
92373 Redlands
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Kaiser Permanente Oncology Research
92505 Riverside
United StatesRekrutierend» Google-Maps
California Cancer Associates for Research and Excellence, Inc. (cCARE)
92069 San Marcos
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Boca Raton Regional Hospital, Lynn Cancer Institute
33486 Boca Raton
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Memorial Regional Hospital
33021 Hollywood
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Baptist MD Anderson Cancer Center
32207 Jacksonville
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Ascension Sacred Heart Medical Oncology
32504 Pensacola
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Goshen Center for Cancer Care
46526 Goshen
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St. Elizabeth Healthcare
41017 Edgewood
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Baptist Health Lexington
40503 Lexington
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Frederick Memorial Healthcare System
21701 Frederick
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St Louis Cancer Care
63044 Bridgeton
United StatesRekrutierend» Google-Maps
Medisearch Clinical Trials
64506 Saint Joseph
United StatesRekrutierend» Google-Maps
St. Vincent - Frontier Cancer Center
59102 Billings
United StatesRekrutierend» Google-Maps
Levine Cancer Institute
28204 Charlotte
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Southeastern Medical Oncology Center
27534 Goldsboro
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Gabrail Cancer Center Research
44718 Canton
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Toledo Clinic Cancer Center
43623 Toledo
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Thomas Jefferson University Medical Oncology Clinic
19107 Philadelphia
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Carolina Blood and Cancer Care Associates
29720 Lancaster
United StatesRekrutierend» Google-Maps
Renovatio Clinical
77380 The Woodlands
United StatesRekrutierend» Google-Maps
Utah Cancer Specialists
84106 Salt Lake City
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Inova Schar Cancer Institute
22031 Fairfax
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Froedtert Hospital, Medical College of Wisconsin
53226 Milwaukee
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University of the Sunshine
4556 Sippy Downs
AustraliaRekrutierend» Google-Maps
Ballarat Health Services
Ballarat
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Virginia Murphy
Phone: +61 3 5320 6732
E-Mail: Virginia.Murphy@bhs.org.au

Donna McIntyre
Phone: +61 3 5320 8624
E-Mail: Donna.McIntyre@bhs.org.au» Ansprechpartner anzeigen
Royal Brisband and Women's Hospital
Brisbane
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Medical Oncology Clinical Trials Unit
Phone: 07 3646 7712
E-Mail: medoncclinicaltrials@health.qld.gov.au» Ansprechpartner anzeigen
Medical University of Graz Department of Dermatology and Venerology
8036 Graz
AustriaRekrutierend» Google-Maps
Univ.-Lkinik für Dermatologie, Venerologie und Allergologie
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ensino e Terapia de Inovação Clίnica AMO-ETICA
41950-610 Salvador
BrazilRekrutierend» Google-Maps
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer,
81520-060 Curitiba
BrazilRekrutierend» Google-Maps
Hospital do Câncer de Londrina
86015-520 Londrina
BrazilRekrutierend» Google-Maps
Hospital São Vicente de Paulo
99010-080 Centro
BrazilRekrutierend» Google-Maps
Centro Gaúcho Integrado de Oncologia, Hematologia
90850-170 Porto Alegre
BrazilRekrutierend» Google-Maps
Hospital de Clίnίcas de Porto Alegre
96810-110 Santa Cruz Do Sul
BrazilRekrutierend» Google-Maps
Oncosite-Centro de Pesquisa Clίnica em Oncologia
98700-000 São Cristóvão
BrazilRekrutierend» Google-Maps
Hopital de Câncer de Barretos-Fundação Pio XII
14784-400 Barretos
BrazilRekrutierend» Google-Maps
CEPHO-Centro de Estudos e Pesquisas de Hematologia e Oncologia
09060-650 Santo André
BrazilRekrutierend» Google-Maps
Fundação Doutor Amaral Carvalho
17210-080 Jaú
BrazilRekrutierend» Google-Maps
Fundação Faculdade Regional de Medicina de São José do Rio Preto
15090-000 São José Do Rio Preto
BrazilRekrutierend» Google-Maps
Instituto do Cancer do Estado de São Paulo - "Octavio Frias de Oliveira"-ICESP
01246-000 São Paulo
BrazilRekrutierend» Google-Maps
Fakultni nemocnice Ostrava Kozni oddeleni
70852 Ostrava-Poruba
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Kralovske Vinohrady
10034 Prague
CzechiaRekrutierend» Google-Maps
CHU de Besançon - Hôpital Jean MINJOZ
Besançon
FranceRekrutierend» Google-Maps
Hôpital Ambroise Paré
Boulogne-Billancourt
FranceRekrutierend» Google-Maps
CHU de Dijon, Service de dermatologie
Dijon
FranceRekrutierend» Google-Maps
CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie
Lille
FranceRekrutierend» Google-Maps
Hôpital La Timone
13385 Cedex 05 Marseille
FranceRekrutierend» Google-Maps
Institut Gustave Roussy, Service de Dermatologie
Villejuif
FranceRekrutierend» Google-Maps
Fondazione IRCCS CA'Granda Ospedale Maggiore Policlinico-Oncologia Medica
20122 Milan
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milan
ItalyRekrutierend» Google-Maps
IRCCS Giovanni Paolo II Oncologia Medica
70124 Bari
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Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
40138 Bologna
ItalyRekrutierend» Google-Maps
Humanitas Istituto Clinico Catanese, U.O. Oncologia Medica
95045 Misterbianco
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - U.O. Oncologia Medica
90127 Palermo
ItalyRekrutierend» Google-Maps
A.O.S. Maria della Misericordia, Oncologia Medica
06132 Perugia
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
00168 Roma
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A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica
53100 Siena
ItalyRekrutierend» Google-Maps
Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona
37134 Verona
ItalyRekrutierend» Google-Maps
Shinshu University Hospital
390-8621 Matsumoto
JapanRekrutierend» Google-Maps
National Hospital Organization Osaka National Hospital
540-0006 Chuo Ku
JapanRekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Nagaizumi-cho
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Koto-Ku
JapanRekrutierend» Google-Maps
National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
541-8567 Osaka
JapanRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Cha University Bundang Medical Center
13496 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Hospital
58128 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Younsei University Health System,
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun
Korea, Republic ofRekrutierend» Google-Maps
Chungnam National University Hospital
35015 Daejeon
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Hospial Oncologico, Puerto Rico Medical Center
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
The Medical Oncology Centre of Rosebank
2196 Johannesburg
South AfricaRekrutierend» Google-Maps
Wilgers Oncology Centre
0081 Pretoria
South AfricaRekrutierend» Google-Maps
West Rand Oncology Centre Flora Clinic
1709 Roodepoort
South AfricaRekrutierend» Google-Maps
Excellentis Clinical Trial Consultants
6529 George
South AfricaRekrutierend» Google-Maps
Cape Town Oncology Trials Cape Gate Oncology Centre
7570 Kraaifontein
South AfricaRekrutierend» Google-Maps
Cancercare Rondebosch Oncology
7700 Rondebosch
South AfricaRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Catalan Institute of Oncology
08908 Barcelona
SpainRekrutierend» Google-Maps
ICO Badalona-Hospital Universitari Germans Trias I Pujol
08916 Barcelona
SpainRekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau
Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Fundación Jimenez Diaz
28040 Madrid
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Centro Integral Oncologico Clara Campal
28050 Madrid
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Hospital Universitario Clinico San Carlos
Madrid
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Hospital Regional Universitario de Málaga
29010 Málaga
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Hospital Universitario Virgen Macarena
Sevilla
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Hospital Universitario Miguel Servet
Zaragoza
SpainRekrutierend» Google-Maps
Nuffield Health Wessex Hospital
SO53 2DW Eastleigh
United KingdomRekrutierend» Google-Maps
Edinburgh Cancer Center Western General Hospital
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of HBI-8000

or Placebo combined with nivolumab. Randomization of eligible patients will be stratified by

PD-L1 expression (positive, ≥1% expression level versus negative, <1% expression level) and

LDH (normal versus elevated) in the main study. Adults with new, progressive brain

metastasis, or adolescents with or without new progressive brain metastasis will be enrolled

in a separate, non-randomized, open-label cohort to receive the combination of HBI-8000 and

nivolumab.

In the main study, eligible patients will be randomized within the appropriate stratum at a

1:1 ratio to the Test arm or the Control arm. Study treatment will be initiated within 3 days

of randomization.

A treatment cycle consists of 28 days. Patients will be treated with one of the following:

Test arm: HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days

Control arm: Placebo oral BIW + nivolumab IV at specific doses on specific days

The Study Treatment (HBI-8000 or Placebo) is administered approximately 30 minutes after a

full meal.

The Study Treatment (HBI-8000 or Placebo) will be administered twice a week on the following

days of every 28-day cycle:

- CxW1: Days 1, 4

- CxW2: Days 8, 11

- CxW3: Days 15, 18

- CxW4: Days 22, 25

Study treatment must commence within 3 days after randomization and continue up to 2 years or

until disease progression (confirmed), unacceptable toxicity or patient withdrawal of

consent.

In addition to Study Treatment, nivolumab is administered at specific doses on specific days

as an intravenous infusion over approximately 30 minutes. Nivolumab will be administered on

Day 1 of each cycle.

For non-randomized cohort for special population, eligible subjects will receive HBI-8000 30

mg oral BIW and nivolumab IV at specific doses on specific days, under the same schedule as

described above. For adolescents weighing < 40 kg, nivolumab will be dosed at specific doses

every 4 weeks. Nivolumab will be administered on Day 1 of each cycle.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Histopathologically confirmed diagnosis of non-uveal, Stage III (unresectable), or

Stage IV (metastatic) melanoma according to AJCC staging system (8th edition).

2. Known BRAF V600 mutation status or consent to BRAF V600 mutation testing before

randomization.

3. Tumor tissue available for PD-L1 testing at central lab. PD-L1 expression level is

required for randomization. In order to be randomized, a patient must be classified as

PD-L1 positive or PD-L1 negative according to the following criteria:

- PD-L1 positive (≥ 1% tumor cell membrane staining in a minimum of a hundred

evaluable tumor cells) vs

- PD-L1 negative (< 1% tumor cell membrane staining in a minimum of a hundred

evaluable tumor cells).

Note: If an insufficient amount of tumor tissue from an unresectable or metastatic

site is available prior to the start of the Screening Phase, patients must consent to

allow the acquisition of additional tumor tissue for assessment of the biomarker.

4. Males or females 12 years of age or older.

5. ECOG performance status ≤1 for age ≥18 years, Lansky performance score ≥80% for age 12

to 17 years.

6. At least one measurable lesion defined by RECIST 1.1 criteria, (separate from the

lesion to be used for tumor tissue collection for PD-L1 testing) not counting brain

metastasis with:

- Longest diameter ≥10 mm by CT (when slice thickness is ≤5 mm); or ≥ 2× slice

thickness (when slice thickness is >5 mm)

- Pathologically enlarged lymph node: ≥15 mm in short axis by CT (when slice

thickness is ≤5 mm)

- Clinical: ≥10 mm (that can be accurately measured with calipers).

7. Have not received anti-PD-1, anti-PD-L1 or other systemic therapy for unresectable or

metastatic melanoma, except for the following, provided that the patient has recovered

from all treatment-related toxicities:

- BRAF mutation targeting therapy > 4 weeks before administration of Study

Treatment.

- Adjuvant or neoadjuvant therapy with PD-1 or PD-L1 inhibitors or anti-CTLA-4) is

allowed if disease progression/or recurrence occurred at least 6 months after the

last dose and no clinically significant immune related toxicities leading to

treatment discontinuation were observed

- Adjuvant interferon therapy must have been completed > 6 weeks before

administration of Study Treatment

8. Any prior radiotherapy or minor surgery must be completed at least 2 weeks and 1 week

respectively before Day 1 dosing and recovered from all treatment related toxicities

9. Screening laboratory results within 14 days prior to randomization:

- Hematology: WBC ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100 × 103/μL,

hemoglobin ≥10.0 g/dL independent of transfusion. The use of erythropoietic

growth factor to achieve hemoglobin (Hgb) ≥ 10 g/dl is acceptable.

- The CrCL≥ 30 mL/min using Cockcroft-Gault formula.

- AST and ALT ≤3 × ULN, alkaline phosphatase ≤2.5 × ULN unless bone metastases

present (patients with documented bone metastases: alkaline phosphatase <5 x

ULN), bilirubin ≤ 1.5 × ULN (unless known Gilbert's disease where it must be ≤ 3

× ULN), serum albumin ≥ 3.0 g/dL).

10. Negative serum pregnancy test at baseline for women of childbearing potential.

11. Females of childbearing potential (non-surgically sterile or premenopausal female

capable of becoming pregnant) and all males (due to potential risk of drug exposure

through the ejaculate) must agree to use adequate birth control measures from study

start, during the study and for 5 months after the last dose of Study Drug. Acceptable

methods of birth control in this trial include two highly effective methods of birth

control (as determined by the Investigator; one of the methods must be a barrier

technique) or abstinence.

12. Have the ability to understand and the willingness to sign a written informed consent

document, comply with study scheduled treatment, visits and assessments.

Exclusion Criteria:

1. History of ≥ Grade 3 hypersensitivity reactions to monoclonal antibodies.

2. Previous treatment with a PD-1, PD-L1, PD-L2, CTLA-4 inhibitor, or any other agents

targeting T-cell co-stimulation or immune checkpoint pathways for unresectable or

metastatic melanoma.

3. History of a cardiovascular illness including: congestive heart failure (New York

Heart Association Grade III or IV); unstable angina or myocardial infarction within

the previous 6 months; or symptomatic cardiac arrhythmia despite medical management.

QT interval corrected by heart rate using QTcF >450 ms in males or >470 ms in females,

or congenital long QT syndrome.

4. Uncontrolled hypertension, systolic blood pressure (SBP) >160 mmHg or diastolic blood

pressure (DBP) >100 mmHg.

5. Patients with new, active, or progressive brain metastases or leptomeningeal disease

with except when considered for a separate special open-label cohort described in

protocol Section 5.3 or "Inclusion of Patients with Progressive Brain Metastasis"

section in the protocol synopsis.

6. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled

peptic ulcer, or bowel resection that affects absorption of orally administered drugs.

7. Active, known, or suspected autoimmune disease, except for Type I diabetes mellitus,

hypothyroidism requiring only hormone replacement, or skin disorders (such as

vitiligo, psoriasis, or alopecia) not requiring systemic therapy.

8. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.

9. Known history of testing positive for HIV, known AIDS.

10. Hepatitis B surface antigen positive or hepatitis C antibody positive. Further

investigation per institutional practices may be performed to exclude active

infection.

11. Patients with a condition requiring chronic systemic treatment with either

corticosteroids (>10 mg daily prednisone or equivalents) or other immunosuppressive

medications within 14 days before administration of Study Treatment. Inhaled or

topical steroids, or adrenal replacement dose of corticosteroids at dose ≤ 10 mg/day

prednisone equivalent are permitted.

12. Use of another investigational agent (drug or vaccine not marketed for any indication)

28 days or before administration of Study Treatment. If the investigational agent is a

monoclonal antibody then within 3 months before administration of Study Treatment

13. Pregnant or breast-feeding women.

14. Second malignancy unless in remission for 2 years or locally curable cancers that have

been treated with curative intent with no evidence of recurrence, such as:

- Basal or squamous cell skin cancer

- Superficial bladder cancer

- Carcinoma in situ of cervix or breast

- Incidental prostate cancer

- Non melanomatous skin cancer

- Carcinoma in situ of the cervix treated with curative intent

- Prostate cancer treated with curative intent with serum prostate specific antigen

(PSA) < 2.0 ng/mL

15. Patients with medical conditions requiring administration of strong cytochrome P450

(CYP), CYP3A4 Inducers and Inhibitors.

16. Uncontrolled adrenal insufficiency or active chronic liver disease.

17. Has received approved live vaccine/live attenuated vaccines within 30 days of planned

Cycle 1 Day 1. Inactivated viral vaccines or vaccines based upon subviral component

are allowed; however intranasal influenza vaccines (e.g. Flu-Mist) are not allowed.

COVID-19 vaccination should be administered at least 7 days before Cycle 1 Day 1.

18. Underlying medical conditions that, in the Investigator's opinion, will make the

administration of Study Treatment hazardous or obscure the interpretation of toxicity

determination or AEs.

19. Unwilling or unable to comply with procedures required in this protocol.

Studien-Rationale

Primary outcome:

1. Primary Outcome (Time Frame - From date of randomization until disease progression or unacceptable toxicity, assessed up to 48 months):
Objective Response Rate (ORR) defined as the percentage of patients enrolled in each study arm with a best response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the blinded independent review committee (BIRC).

2. Primary Outcome (Time Frame - From date of randomization to the earliest date of documented progressive disease (PD), assessed up to 48 months):
Progression-free Survival (PFS) defined as the time from the date of randomization to the first date of documented disease progression as determined by BIRC, or the date of death due to any cause, whichever occurs first.

Secondary outcome:

1. Secondary Outcome (Time Frame - From date of randomization to death due to any cause, assessed up to 48 months):
Overall Survival (OS) defined as the time from date of randomization to the date of death due to any cause.

2. Secondary Outcome (Time Frame - From date of randomization until the end of study, assessed up to 48 months):
Safety defined as incidence rate of adverse events (AEs), severity (CTCAE v.5.0), causal relationship assessment, and outcomes of reported AEs.

Studien-Arme

  • Experimental: Test Arm
    HBI-8000 30 mg oral BIW + nivolumab IV at specific doses on specific days
  • Placebo Comparator: Control Arm
    Placebo oral BIW + nivolumab IV at specific doses on specific days

Geprüfte Regime

  • HBI-8000 in combination with nivolumab (For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®):
    Patients will take 30 mg of HBI-8000 orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV will be administered by intravenous infusion at specific doses on specific days in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice. In adolescent patients with body weight < 40 kg, nivolumab will be dosed at specific doses on specific days.
  • Placebo in combination with nivolumab (For nivolumab: OPDIVO®):
    Patients will take 30 mg of Placebo orally approximately 30 minutes after a full meal, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab IV at specific doses will be administered by intravenous infusion in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice.

Quelle: ClinicalTrials.gov


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