A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

PHASE2CompletedINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

February 14, 2023

Study Completion Date

November 7, 2024

Conditions
Cancer of Unknown Primary Site
Interventions
DRUG

Alectinib

Alectinib will be administered orally at the label-recommended dose (600 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Vismodegib

Vismodegib will be administered orally at the label-recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Ipatasertib

Ipatasertib will be administered orally at the label-recommended dose (400 mg) once daily on Days 1-21 of each 28-day Cycle in combination with paclitaxel, and as monotherapy after the final administration of paclitaxel, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Olaparib

Olaparib will be administered orally at the label-recommended dose (400 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Erlotinib

Erlotinib will be administered orally in combination with Bevacizumab at the label recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Bevacizumab

Bevacizumab will be administered intravenously at 15mg/kg every 3 weeks in combination with Erlotinib until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Vemurafenib

Vemurafenib will be administered orally, 960 mg twice daily, in combination with Cobimetinib, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Cobimetinib

Cobimetinib will be administered orally, 60mg once daily, in combination with Vemurafenib, on Days 1-21 of each 28-day Cycle, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Trastuzumab Subcutaneous (SC)

Trastuzumab will be administered subcutaneously, 600 mg every 3 weeks, in combination with Pertuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Pertuzumab

Pertuzumab will be initially be administered intravenously, 840 mg, followed by 420 mg every 3 weeks, in combination with Trastuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

DRUG

Atezolizumab

Atezolizumab will be administered intravenously at the label-recommended dose (1200 mg), alone or in combination with chemotherapy, every 3 weeks until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Carboplatin

Carboplatin will be administered intravenously at the area under the curve (AUC) dose once every 3 weeks for up to 9 Cycles (Cycle = 21 days) in some combination with the following: Paclitaxel, Gemcitabine, Atezolizumab, Pertuzumab, and Trastuzumab SC.

DRUG

Paclitaxel

Paclitaxel will be administered intravenously, 175 mg/m\^2, once every 3 weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Carboplatin, Ipatasertib, Atezolizumab, Pertuzumab, and Trastuzumab SC

DRUG

Cisplatin

Cisplatin will be administered intravenously, 60-75 mg/m\^2, once every three weeks, for up to 9 cycles (Cycle = 21 days) in some combination with the following: Gemcitabine, Paclitaxel, Atezolizumab, Pertuzumab, and Trastuzumab SC.

DRUG

Gemcitabine

Gemcitabine will be administered intravenously, 1000 mg/m\^2, twice every three weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Cisplatin, Carboplatin, Atezolizumab, Pertuzumab, and Trastuzumab SC.

DRUG

Entrectinib

Entrectinib will be administered orally at the label-recommended dose (600 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

DRUG

Ivosidenib

Ivosidenib will be administered orally at the label-recommended dose (500mg) once daily across a 28-day treatment cycle until loss of clinical benefit or unacceptable toxicity.

DRUG

Pemigatinib

Pemigatinib will be administered orally at the label-recommended dose (13.5mg) once daily across a 21-day treatment cycle until loss of clinical benefit or unacceptable toxicity.

Trial Locations (130)

41

Oncosalud Sac, Lima

1090

Medizinische Universität Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

1145

Budapesti Uzsoki Utcai Kórház, Budapest

1330

MHAT Nadezhda, Sofia

1478

Akershus universitetssykehus HF, Lørenskog

1632

MBAL Serdika EOOD, Sofia

2065

GenesisCare North Shore, St Leonards

2100

Rigshospitalet, København Ø

3000

Peter MacCallum Cancer Center, Melbourne

4031

Universitaetsspital Basel, Basel

4101

Icon Cancer Foundation, South Brisbane

4604

Sørlandet Sykehus Kristiansand, Kristiansand

5020

Lkh Salzburg - Univ. Klinikum Salzburg, Salzburg

5042

Flinders Medical Centre, Bedford Park

6000

Bács-Kiskun Vármegyei Oktatókórház, Kecskemét

8036

Lkh-Univ. Klinikum Graz, Graz

8091

UniversitätsSpital Zürich, Zurich

8200

Aarhus Universitetshospital, Aarhus N

10000

Clinical Hospital Centre Zagreb, Zagreb

10400

Ramathibodi Hospital;Medicine/Oncology, Bangkok

10700

Faculty of Med. Siriraj Hosp., Bangkok

11001

Clinica del Country, Bogotá

13273

Institut Paoli-Calmettes, Marseille

13353

Charité-Universitätsm. Berlin, Berlin

13419

North Estonia Medical Centre, Oncology and hematology Clinic, Tallinn

14076

CRLCC-Francois Baclesse, Caen

15038

Instituto Nacional de Enfermedades Neoplasicas, Lima

20162

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda), Milan

22030

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi, Edirne

23758

RED-Oncology GmbH, Oldenburg / Holstein

24128

Asst Papa Giovanni XXIII, Bergamo

25030

CHRU Besançon, Besançon

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

31008

Complejo Hospitalario de Navarra, Pamplona

33076

Institut Bergonie, Bordeaux

33520

Tampere University Hospital, Tampere

34098

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty, Istanbul

34298

Institut régional du Cancer Montpellier, Montpellier

35042

Centre Eugene Marquis, Rennes

35128

IRCCS Istituto Oncologico Veneto (IOV), Padua

35575

?zmir Medical Point, Kar?iyaka

36312

Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro, Vigo

41009

Hospital Universitario Virgen Macarena, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

45136

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

48149

Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie, Münster

49000

Ico - Paul Papin, Angers

50009

Hospital Universitario Miguel Servet, Zaragoza

56100

U. O. Oncologia Medica, Ospedale Santa Chiara, Pisa

60590

Universitätsklinikum Frankfurt, UCT, Frankfurt

63003

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne, Clermont-Ferrand

64710

AVIX Investigación Clínica S.C, Monterrey

67098

CHU Strasbourg Hôpital Hautepierre, Strasbourg

68167

Klinikum Mannheim III. Medizinische Klinik, Mannheim

69008

Centre Leon Berard, Lyon

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon)

74078

SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III, Heilbronn

75231

Institut Curie, Paris

80131

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

81377

Klinikum der LMU München, Campus Großhadern, Krebszentrum München, München

85221

Onkologisches Zentrum - Onkologie Dachau, Dachau

86156

Universitätsklinikum Augsburg, Augsburg

88100

Policlinico Univ. - A.O. Mater Domini, Catanzaro

92151

Hopital Foch, Suresnes

94805

Institut Gustave Roussy, Villejuif

200347

Centrul de Oncologie Sfantul Nectarie, Craiova

230002

Oncomedica S.A., Montería

300166

Oncocenter Timisoara, Timi?oara

400015

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca, Cluj-Napoca

700483

Institutul Regional de Oncologie Iasi, Iași

4800827

James Lind Centro de Investigación Del Cáncer, Temuco

4941492

Rabin MC, Petah Tikva

5262000

Chaim Sheba medical center, Oncology division, Ramat Gan

6423906

Tel Aviv Sourasky Medical Ctr, Tel Aviv

8420383

Bradford Hill Centro de Investigaciones Clinicas, Recoleta

NSW 2148

Blacktown Hospital, Blacktown

41253-190

Hospital Sao Rafael - HSR, Salvador

14784-400

Hospital de Cancer de Barretos, Barretos

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

20560-120

Instituto Nacional de Cancer - INCa, Rio de Janeiro

Unknown

Inst. Nacional de Cancerologia, Bogotá

656 53

Masarykuv onkologicky ustav, Brno

779 00

Fakultni nemocnice Olomouc, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice, Prague

00250

Helsinki University Central Hospital, Helsinki

06189

Centre Antoine Lacassagne, Nice

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

07740

Universitätsklinikum Jena, Klinik für Innere Medizin II, Jena

115 22

Anticancer Hospital Ag Savas, Athens

155 62

IASO General Hospital of Athens, Athens

711 10

Univ General Hosp Heraklion, Heraklion

455 00

Uni Hospital of Ioannina, Ioannina

540 07

Theagenio Anticancer Hospital, Thessaloniki

D04 T6F4

St Vincent'S Uni Hospital, Dublin

X91 ER8E

Waterford Regional Hospital, Waterford

277-8577

National Cancer Center Hospital East, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

LV-1079

Riga East Clinical University Hospital Latvian Oncology Centre, Riga

03810

Health Pharma Professional Research, CD Mexico

3015 GD

Erasmus MC, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

5912 BL

Ziekenhuis VieCuri Medisch Centrum, Venlo

0450

Oslo universitetssykehus HF, Ullevål, Kreftsenteret, Oslo

30-688

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Krakow

4200-072

IPO do Porto, Porto

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

120-752

Severance Hospital, Yonsei University Health System, Seoul

08970

Hospital Sant Joan Despi- Moises Broggi, Sant Joan Despí

08036

Hospital Clínic i Provincial, Barcelona

08908

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

01250

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital, Adana

06100

Ankara University Medical Faculty, Ankara

Hacettepe Uni Medical Faculty Hospital, S?hhiye, Ankara

06200

Ankara Oncology Hospital, Ankara

07070

Akdeniz University Medical Faculty, Antalya

BA1 3NG

Royal United Hospital, Bath

CF14 2TL

Velindre Cancer Centre, Cardiff

EH4 2XU

Western General Hospital, Edinburgh

W12 0HS

Hammersmith Hospital, London

M20 4BX

Christie Hospital NHS Trust, Manchester

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

SO16 6YD

Southampton General Hospital, Southampton

TQ27AA

Torbay Hospital, Torquay

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Foundation Medicine

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY