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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 (CUPISCO)

Primary Purpose

Cancer of Unknown Primary Site

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Alectinib
Vismodegib
Ipatasertib
Olaparib
Erlotinib
Bevacizumab
Vemurafenib
Cobimetinib
Trastuzumab Subcutaneous (SC)
Pertuzumab
Atezolizumab
Carboplatin
Paclitaxel
Cisplatin
Gemcitabine
Entrectinib
Ivosidenib
Pemigatinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Unknown Primary Site

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP
  • No prior lines of systemic therapy for the treatment of CUP
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy)
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  • Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample </= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory

Exclusion Criteria:

  • Squamous cell CUP
  • Participants who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis CUP subsets): Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive, CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast; high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF; IHC profile compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver
  • Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only)
  • Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma
  • History or known presence of leptomeningeal disease
  • Known human immunodeficiency virus (HIV) infection
  • Significant cardiovascular disease
  • Prior allogeneic stem cell or solid organ transplantation
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 7 months after the final dose of treatment

Sites / Locations

  • Blacktown Hospital
  • Northern Cancer Institute
  • Icon Cancer Foundation
  • Flinders Medical Centre
  • Peter MacCallum Cancer Center
  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
  • Hospital Sao Rafael - HSR
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Hospital Nossa Senhora da Conceicao
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • MHAT Nadezhda
  • MBAL Serdika EOOD
  • Bradford Hill Centro de Investigaciones Clinicas
  • James Lind Centro de Investigación Del Cáncer
  • Clinica del Country
  • Inst. Nacional de Cancerologia; Clinica de Seno
  • Oncomedica S.A.
  • Clinical Hospital Centre Zagreb
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
  • Aarhus Universitetshospital; Afdeling for Eksperimentel Klinisk Onkologi
  • Rigshospitalet; Onkologisk Klinik
  • North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy
  • Helsinki University Central Hospital; Dept of Oncology
  • Tampere University Hospital; Dept of Oncology
  • Ico - Paul Papin
  • CHRU Besançon
  • Institut Bergonie; Oncologie
  • CRLCC-Francois Baclesse; Oncologie Médicale
  • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
  • Centre Leon Berard
  • Institut Paoli-Calmettes; Oncologie Medicale 1
  • Institut régional du Cancer Montpellier
  • Centre Antoine Lacassagne
  • Institut Curie; Oncologie Medicale
  • CHU Lyon - Centre Hospitalier Lyon Sud
  • Centre Eugene Marquis; Service d'oncologie
  • CHU Strasbourg Hôpital Hautepierre
  • Hopital Foch; Oncologie
  • Institut Gustave Roussy
  • Universitätsklinikum Augsburg; II. Med. Klinik
  • Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
  • Onkologisches Zentrum - Onkologie Dachau
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
  • Universitätsklinikum Düsseldorf; Klinik für Hämatologie, Onkologie und Klinische Immunologie
  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
  • Universitätsklinikum Frankfurt, UCT; Universitäres Centrum für Tumorerkrankungen
  • Universitätsklinikum Heidelberg;Innere Medizin V, Hämatologie/Onkologie
  • SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.
  • Universitätsklinikum Jena, Klinik für Innere Medizin II; Hämatologie und Internistische Onkologie
  • Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
  • Klinikum Mannheim III. Medizinische Klinik
  • Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU
  • Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
  • RED-Oncology GmbH; Dres.Gerdt Hübner/Clemens Engels (Oldenburg)/Yael Bonnin-Gruber (Eutin)
  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • IASO General Hospital of Athens
  • Univ General Hosp Heraklion; Medical Oncology
  • Uni Hospital of Ioannina; Oncology Dept.
  • Theagenio Anticancer Hospital; 3Rd Oncology Clinic
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály
  • Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ
  • St Vincent'S Uni Hospital; Medical Oncology
  • Waterford Regional Hospital; Department Of Medical Oncology
  • Rabin MC; Davidof Center - Oncology Institute
  • Chaim Sheba medical center, Oncology division
  • Tel Aviv Sourasky Medical Ctr; Oncology
  • U. O. Oncologia Medica, Ospedale Santa Chiara
  • Policlinico Univ. - A.O. Mater Domini; U.O. Di Oncoematologia
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Arcispedale Santa Maria Nuova; Oncologia
  • Asst Papa Giovanni XXIII; Oncologia Medica
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Aichi Cancer Center
  • National Cancer Center Hospital East
  • National Hospital Organization Kyushu Cancer Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System; Oncology
  • Riga East Clinical University Hospital Latvian Oncology Centre
  • Health Pharma Professional Research
  • AVIX Investigación Clínica S.C
  • Erasmus MC
  • Universitair Medisch Centrum Utrecht
  • Ziekenhuis VieCuri Medisch Centrum
  • Sørlandet Sykehus Kristiansand
  • Akershus universitetssykehus HF
  • Oslo universitetssykehus HF, Ullevål, Kreftsenteret
  • Oncosalud Sac; Oncología
  • Instituto Nacional de Enfermedades Neoplasicas
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz
  • IPO do Porto; Servico de Oncologia Medica
  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
  • Centrul de Oncologie Sfantul Nectarie
  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie
  • Oncocenter Timisoara
  • Hospital Sant Joan Despi- Moises Broggi; Servicio de Oncologia
  • Complejo Hospitalario de Navarra; Servicio de Oncologia
  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Institut Catala d Oncologia Hospital Duran i Reynals
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Hospital Universitari i Politecnic La Fe; Oncologia
  • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Universitaetsspital Basel; Onkologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Ankara University Medical Faculty; Medikal Onkoloji
  • Ankara Oncology Hospital; Oncology
  • Akdeniz University Medical Faculty; Medical Oncology Department
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
  • ?zmir Medical Point; Oncology
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Royal United Hospital; Oncology Department
  • Velindre Cancer Centre
  • Western General Hospital; Edinburgh Cancer Center
  • Beatson West of Scotland Cancer Centre
  • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Hammersmith Hospital; Garry Weston Centre
  • Christie Hospital NHS Trust
  • Freeman Hospital
  • Southampton General Hospital
  • Torbay Hospital; Oncology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Molecularly-Guided Therapy

Platinum-Based Chemotherapy

Arm Description

Participants will be assigned to molecularly-guided therapy based on genomic profile.

Participants will receive platinum-based chemotherapy (Carboplatin or Cisplatin in combination with Gemcitabine or Paclitaxel).

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS1)

Secondary Outcome Measures

Overall Survival (OS)
Objective Response Rate (ORR1)
Duration of Response (DOR1)
Disease Control Rate (DCR1)
Percentage of Participants with Adverse Events (AEs)

Full Information

First Posted
April 5, 2018
Last Updated
August 24, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Foundation Medicine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03498521
Brief Title
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
Acronym
CUPISCO
Official Title
A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
June 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Foundation Medicine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Unknown Primary Site

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
790 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Molecularly-Guided Therapy
Arm Type
Experimental
Arm Description
Participants will be assigned to molecularly-guided therapy based on genomic profile.
Arm Title
Platinum-Based Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive platinum-based chemotherapy (Carboplatin or Cisplatin in combination with Gemcitabine or Paclitaxel).
Intervention Type
Drug
Intervention Name(s)
Alectinib
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Vismodegib
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Vemurafenib
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Subcutaneous (SC)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Entrectinib
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Ivosidenib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS1)
Time Frame
From randomization to the first occurrence of disease progression as assessed by the investigator according to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) or death from any cause, through the end of study (approximately 70 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause, through the end of study (approximately 70 months)
Title
Objective Response Rate (ORR1)
Time Frame
Two consecutive occurrences of complete or partial response >/=4 weeks apart
Title
Duration of Response (DOR1)
Time Frame
From the first documentation of a complete response (CR) or partial response (PR) to disease progression or death from any cause, whichever occurs first (up to approximately 70 months)
Title
Disease Control Rate (DCR1)
Time Frame
From randomization to death from any cause, through the end of study (approximately 70 months)
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
From baseline through the end of study (approximately 70 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP No prior lines of systemic therapy for the treatment of CUP Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample </= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory Exclusion Criteria: Squamous cell CUP Participants who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis CUP subsets): Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive, CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast; high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF; IHC profile compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only) Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma History or known presence of leptomeningeal disease Known human immunodeficiency virus (HIV) infection Significant cardiovascular disease Prior allogeneic stem cell or solid organ transplantation Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 7 months after the final dose of treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Blacktown Hospital
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Northern Cancer Institute
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Icon Cancer Foundation
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Peter MacCallum Cancer Center
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Facility Name
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
MHAT Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
MBAL Serdika EOOD
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
Facility Name
Bradford Hill Centro de Investigaciones Clinicas
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Facility Name
James Lind Centro de Investigación Del Cáncer
City
Temuco
ZIP/Postal Code
4800827
Country
Chile
Facility Name
Clinica del Country
City
Bogota
ZIP/Postal Code
11001
Country
Colombia
Facility Name
Inst. Nacional de Cancerologia; Clinica de Seno
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Aarhus Universitetshospital; Afdeling for Eksperimentel Klinisk Onkologi
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet; Onkologisk Klinik
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Helsinki University Central Hospital; Dept of Oncology
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Facility Name
Tampere University Hospital; Dept of Oncology
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Ico - Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHRU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie; Oncologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CRLCC-Francois Baclesse; Oncologie Médicale
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Paoli-Calmettes; Oncologie Medicale 1
City
Marseille Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
CHU Lyon - Centre Hospitalier Lyon Sud
City
Pierre-Benite (Lyon)
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Eugene Marquis; Service d'oncologie
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
CHU Strasbourg Hôpital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Foch; Oncologie
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum Augsburg; II. Med. Klinik
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Onkologisches Zentrum - Onkologie Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf; Klinik für Hämatologie, Onkologie und Klinische Immunologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitätsklinikum Frankfurt, UCT; Universitäres Centrum für Tumorerkrankungen
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Heidelberg;Innere Medizin V, Hämatologie/Onkologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin II; Hämatologie und Internistische Onkologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Mannheim III. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
RED-Oncology GmbH; Dres.Gerdt Hübner/Clemens Engels (Oldenburg)/Yael Bonnin-Gruber (Eutin)
City
Oldenburg / Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
IASO General Hospital of Athens
City
Athens
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Univ General Hosp Heraklion; Medical Oncology
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
Uni Hospital of Ioannina; Oncology Dept.
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Theagenio Anticancer Hospital; 3Rd Oncology Clinic
City
Thessaloniki
ZIP/Postal Code
546 39
Country
Greece
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
St Vincent'S Uni Hospital; Medical Oncology
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Waterford Regional Hospital; Department Of Medical Oncology
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba medical center, Oncology division
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
U. O. Oncologia Medica, Ospedale Santa Chiara
City
Pisa
State/Province
Basilicata
ZIP/Postal Code
56100
Country
Italy
Facility Name
Policlinico Univ. - A.O. Mater Domini; U.O. Di Oncoematologia
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova; Oncologia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System; Oncology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Riga East Clinical University Hospital Latvian Oncology Centre
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
AVIX Investigación Clínica S.C
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Ziekenhuis VieCuri Medisch Centrum
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Sørlandet Sykehus Kristiansand
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Akershus universitetssykehus HF
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Oncosalud Sac; Oncología
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Centrul de Oncologie Sfantul Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Oncocenter Timisoara
City
Timi?oara
ZIP/Postal Code
300166
Country
Romania
Facility Name
Hospital Sant Joan Despi- Moises Broggi; Servicio de Oncologia
City
Sant Joan Despí
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Facility Name
Complejo Hospitalario de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe; Oncologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Facility Name
Ankara University Medical Faculty; Medikal Onkoloji
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Oncology Hospital; Oncology
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Akdeniz University Medical Faculty; Medical Oncology Department
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
?zmir Medical Point; Oncology
City
Kar?iyaka
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Royal United Hospital; Oncology Department
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Western General Hospital; Edinburgh Cancer Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Hammersmith Hospital; Garry Weston Centre
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Torbay Hospital; Oncology Department
City
Torquay
ZIP/Postal Code
TQ27AA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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