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)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Unknown Primary Site
• Intervention / Treatment: Drug: Paclitaxel; Drug: Ivosidenib; Drug: Pemigatinib; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Alectinib; Drug: Vismodegib; Drug: Ipatasertib; Drug: Olaparib; Drug: Erlotinib; Drug: Bevacizumab; Drug: Vemurafenib; Drug: Cobimetinib; Drug: Trastuzumab Subcutaneous (SC); Drug: Pertuzumab; Drug: Atezolizumab; Drug: Entrectinib

• Study Type: Interventional
• Enrollment (Actual): 529
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Blacktown Hospital
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare North Shore
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
• Austria
  • Graz, Austria, 8036
    • Lkh-Univ. Klinikum Graz
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg
  • Vienna, Austria, 1090
    • Medizinische Universität Wien
• Brazil
  • Rio de Janeiro, Brazil, 20560-120
    • Instituto Nacional de Câncer - INCA
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Hospital Sao Rafael - HSR
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Hospital de Cancer de Barretos
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Bulgaria
  • Sofia, Bulgaria, 1330
    • MHAT Nadezhda
  • Sofia, Bulgaria, 1632
    • MBAL Serdika EOOD
• Chile
  • Recoleta, Chile, 8420383
    • Bradford Hill Centro de Investigaciones Clinicas
  • Temuco, Chile, 4800827
    • James Lind Centro de Investigacion del Cancer
• Colombia
  • Bogotá, Colombia
    • Inst. Nacional de Cancerologia
  • Bogotá, Colombia, 11001
    • Clinica del Country
  • Montería, Colombia, 230002
    • Oncomedica S.A.
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv Onkologicky Ustav
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Prague, Czechia, 128 08
    • Fakultni Poliklinika Vseobecne Fakultni Niemocnice
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre, Oncology and hematology Clinic
• Finland
  • Helsinki, Finland, 00250
    • Helsinki University Central Hospital
  • Tampere, Finland, 33520
    • Tampere University Hospital
• France
  • Angers, France, 49000
    • ICO - Paul Papin
  • Besançon, France, 25030
    • CHRU Besançon
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Caen, France, 14076
    • CRLCC-Francois Baclesse
  • Clermont-Ferrand, France, 63003
    • Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille, France, 13273
    • Institut Paoli-Calmettes
  • Montpellier, France, 34298
    • Institut Régional du Cancer Montpellier
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75231
    • Institut Curie
  • Pierre-Benite (Lyon), France, 69495
    • CHU Lyon - Centre Hospitalier Lyon Sud
  • Rennes, France, 35042
    • Centre Eugène Marquis
  • Strasbourg, France, 67098
    • CHU Strasbourg Hpital Hautepierre
  • Suresnes, France, 92151
    • Hôpital Foch
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Augsburg, Germany, 86156
    • Universitätsklinikum Augsburg
  • Berlin, Germany, 13353
    • Charité-Universitätsm. Berlin
  • Dachau, Germany, 85221
    • Onkologisches Zentrum - Onkologie Dachau
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt, UCT
  • Heilbronn, Germany, 74078
    • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
  • Jena, Germany, 07740
    • Universitätsklinikum Jena, Klinik für Innere Medizin II
  • Mannheim, Germany, 68167
    • Klinikum Mannheim III. Medizinische Klinik
  • München, Germany, 81377
    • Klinikum der LMU München, Campus Großhadern, Krebszentrum München
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie
  • Oldenburg / Holstein, Germany, 23758
    • RED-Oncology GmbH
• Greece
  • Athens, Greece, 155 62
    • IASO General Hospital of Athens
  • Athens, Greece, 115 22
    • Anticancer Hospital Ag Savas
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion
  • Ioannina, Greece, 455 00
    • Uni Hospital of Ioannina
  • Thessaloniki, Greece, 540 07
    • Theagenio Anticancer Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1145
    • Budapesti Uzsoki Utcai Korhaz
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Vármegyei Oktatókórház
• Ireland
  • Dublin, Ireland, D04 T6F4
    • St Vincent'S Uni Hospital
  • Waterford, Ireland, X91 ER8E
    • Waterford Regional Hospital
• Israel
  • Petah Tikva, Israel, 4941492
    • Rabin MC
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba medical center, Oncology division
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Ctr
• Italy
  • Basilicate
    • Pisa, Basilicate, Italy, 56100
      • U. O. Oncologia Medica, Ospedale Santa Chiara
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Policlinico Univ. - A.O. Mater Domini
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
  • Emilia-Romagna
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • Arcispedale Santa Maria Nuova
  • Lombardy
    • Bergamo, Lombardy, Italy, 24128
      • ASST Papa Giovanni XXIII
    • Milan, Lombardy, Italy, 20162
      • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
  • Veneto
    • Padua, Veneto, Italy, 35128
      • IRCCS Istituto Oncologico Veneto (IOV)
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
• Latvia
  • Riga, Latvia, LV-1079
    • Riga East Clinical University Hospital Latvian Oncology Centre
• Mexico
  • Mexico CITY (federal District)
    • CD Mexico, Mexico CITY (federal District), Mexico, 03810
      • Health Pharma Professional Research
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64710
      • AVIX Investigación Clínica S.C
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Venlo, Netherlands, 5912 BL
    • Ziekenhuis VieCuri Medisch Centrum
• Norway
  • Kristiansand, Norway, 4604
    • Sørlandet Sykehus Kristiansand
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus HF
  • Oslo, Norway, 0450
    • Oslo universitetssykehus HF, Ullevål, Kreftsenteret
• Peru
  • Lima, Peru, 15038
    • Instituto Nacional de Enfermedades Neoplasicas
  • Lima, Peru, 41
    • Oncosalud Sac
• Poland
  • Krakow, Poland, 30-688
    • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
• Portugal
  • Porto, Portugal, 4200-072
    • IPO do Porto
• Romania
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
  • Craiova, Romania, 200347
    • Centrul de Oncologie Sfantul Nectarie
  • Iași, Romania, 700483
    • Institutul Regional de Oncologie Iasi
  • Timi?oara, Romania, 300166
    • Oncocenter Timisoara
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 120-752
    • Severance Hospital, Yonsei University Health System
• Spain
  • Barcelona, Spain, 08908
    • Institut Catala d Oncologia Hospital Duran i Reynals
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Málaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Hospital Sant Joan Despi- Moises Broggi
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Complejo Hospitalario de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Zurich, Switzerland, 8091
    • UniversitätsSpital Zürich
• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital;Medicine/Oncology
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
  • Ankara, Turkey (Türkiye), 06100
    • Ankara University Medical Faculty
  • Ankara, Turkey (Türkiye), 06200
    • Ankara Oncology Hospital
  • Antalya, Turkey (Türkiye), 07070
    • Akdeniz University Medical Faculty
  • Edirne, Turkey (Türkiye), 22030
    • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty
  • Kar?iyaka, Turkey (Türkiye), 35575
    • ?zmir Medical Point
  • S?hhiye, Ankara, Turkey (Türkiye), 06100
    • Hacettepe Uni Medical Faculty Hospital
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre Cancer Centre
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital Nhs Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Torquay, United Kingdom, TQ27AA
    • Torbay Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Molecularly-Guided Therapy; Participants will be assigned to molecularly-guided therapy based on genomic profile.	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: 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.; 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: 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).
Active Comparator: Platinum-Based Chemotherapy; Participants will receive platinum-based chemotherapy (Carboplatin or Cisplatin in combination with Gemcitabine or Paclitaxel).	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: 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: 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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)	This efficacy objective was to evaluate the efficacy of MGT vs platinum chemotherapy in term of PFS in participants with CUP whose best response to 3 cycles of platinum induction chemotherapy was assessed CR, PR, or SD.	From randomization to the first occurrence of disease progression or death from any cause, until 330 PFS events were observed (approx. 4.3 years for MGT Cat 1 and 3.4 years for Chemotherapy Cat 1).

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	From randomization to death from any cause (approx. 4 years)
Objective Response Rate (ORR)	Two consecutive occurrences of complete or partial response >/=4 weeks apart (up to approximately 4 months)
Duration of Response (DOR)	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 4 years)
Disease Control Rate (DCR)	From randomization to death from any cause, through the end of study (approximately 4 years)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Foundation Medicine
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Kramer A, Bochtler T, Pauli C, Shiu KK, Cook N, de Menezes JJ, Pazo-Cid RA, Losa F, Robbrecht DG, Tomasek J, Arslan C, Ozguroglu M, Stahl M, Bigot F, Kim SY, Naito Y, Italiano A, Chalabi N, Duran-Pacheco G, Michaud C, Scarato J, Thomas M, Ross JS, Moch H, Mileshkin L. Molecularly guided therapy versus chemotherapy after disease control in unfavourable cancer of unknown primary (CUPISCO): an open-label, randomised, phase 2 study. Lancet. 2024 Aug 10;404(10452):527-539. doi: 10.1016/S0140-6736(24)00814-6. Epub 2024 Jul 31.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): November 7, 2024

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Neoplasms, Unknown Primary; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Amides; Indoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Platinum Compounds; Sulfonamides; Sulfones; Quinazolines; Erlotinib Hydrochloride; Bevacizumab; Vemurafenib; Gemcitabine; Carboplatin; Paclitaxel; Cisplatin; pertuzumab; ipatasertib; atezolizumab; olaparib; cobimetinib; entrectinib; pemigatinib; alectinib; HhAntag691; ivosidenib
• Other Study ID Numbers: MX39795; 2017-003040-20 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• 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